Automatic analyser

IS 2 174 154 T3

DESCRIPTION

Automatic analyzer.

Background

The present invention relates generally to methods and structures that determine an element of interest in a sample.

To obtain information about the health of a patient, various analyzes can be performed on a sample from the patient, such as the patient's body fluids. These bodily fluids can include blood, urine, etc. Tests performed on the patient's body fluids can determine an item of interest in the body fluids. Based on the determination of the element of interest in the patient's body fluids, information about the patient's health status can be obtained.

WO-A-96/25712 describes a system and method for directing sample containers to an analysis station. The known system provides several auxiliary lines and glue lines containing a plurality of samples. No process steps are performed in the auxiliary lines or in the tail lines. Instead, the samples are moved or aspirated to the testing equipment where testing is performed to determine an item of interest. The analysis equipment can be any known type of analyzer.

FR-A-2 144 110 describes a routing structure similar to that of WO-A-95/25712. Specifically, FR-A-2 144 110 has a service line that reaches an extraction station that includes a calibrated needle adapted to extract a given quantity of substance from a cuvette, the given quantity being transported by known means to a station. analyzer. Exit lines and waiting lines have also been planned. In one embodiment of FR-A-2 144 110 the various lines are defined by circular rails at the peripheral edge of a rotating plate, with piston-like transfer stations that move the trays transversely between the lines.

DE-A-39 34 890 describes a system for routing a sample cup between at least two analysis modules. In the known apparatus of DE-A-39 34 890 a cup is directed to an analysis route or a bypass route associated with an analysis module depending on whether the sample contained in the sample cup requires analysis of a particular element that it can be analyzed by the particular analysis module. The known apparatus from DE-A-39 34 890 merely inserts a sample cup into an analysis module if and only if the sample has to be analyzed by said analysis module. Thus, in other terms, if a sample cup is directed to an analysis module, said sample will be analyzed by said module.

EP-A-567 892 describes a processing station for performing fluorescence polarization measurement in an assay device. The known device includes a conveyor from which the cuvettes are automatically fed to a measuring device along a circular path in a carousel.

US-A-5 244 633 describes an analyzer incubator with multiple independently moved rings supporting cuvettes. An outer ring of the analyzer is provided with slots that house the cuvettes and open towards the axis of the inner ring. The inner ring does not include grooves. Transfer stations have been arranged to transversely move the trays from the outer ring to the inner and vice versa, the transfer stations being equipped with transversely acting push rods.

EP-A-712 000 describes an automated cuvette ring immunoassay analyzer.

In view of the foregoing, the present invention provides a structure and method for performing a process to determine an item of interest in a sample, as defined in claims 1 and 16.

Other advantageous features of the present invention are defined in the dependent claims.

Brief description of the drawings

Figure 1 is a perspective view of a component of an analyzer.

Figure 2 shows the component of Figure 1 with its elements removed for clarity.

IS 2 174 154 T3

Figure 3 is a perspective view of an element of the component shown in Figure 1.

Figure 4 is a top view of the component of Figure 1 with its elements removed for clarity.

Figures 5A and 5B show another element of the component of Figure 1 that is connected with the structure shown in Figure 2.

Figure 6 is an enlarged sectional view of the component of Figure 1 with elements removed for clarity.

Figure 7A is a perspective view of a container for use with the component of Figure 1.

Figure 7B is a perspective view of another container for use with the component of Figure 1.

Figure 8 is an enlarged sectional view of a portion of the component of Figure 1 showing interaction with the container of Figure 7B.

Figure 9 is an enlarged sectional view, substantially similar to that of Figure 8, of another portion of the component of Figure 1.

Figure 10 is substantially similar to Figure 9, but shows another portion of the component of Figure 1.

Figure 11 is substantially similar to Figure 10, but shows another portion of the component of Figure 1.

Figure 12 is a perspective view of an element of the component of Figure 1.

Figure 13 is an enlarged sectional view of a section of another embodiment of the component shown in Figure 1.

Figure 14 is a perspective view of an element of the component of Figure 1.

Figure 15 is a perspective view of an element of the component of Figure 1.

Figure 16 is a generic view of the component of Figure 1 that cooperates with other portions of an analyzer.

Figure 17 is a perspective view of a frame for the structures shown in Figure 16.

Figures 18A, 18B and 18C illustrate an element of the component shown in Figure 1.

Figure 19 is an enlarged sectional view of a section of another embodiment substantially similar to that shown in Figure 13.

Figures 20A and 20B are generic views of other related analyzers having counter-directed components substantially similar to the component of Figure 1.

Figures 21A, 21B and 21C show an embodiment of a high-density data carrier that can be used with the component of Figure 1.

Figure 22 is an isometric view of a container for use with the process path of Figure.

1.

Figures 23A, 23B and 23C show another container for use with the process path of Figure

1.

Figures 24A and 24B are enlarged sectional views of a portion of the container of Figures 23A, 23B and 23C operatively associated with a support.

IS 2 174 154 T3

Figure 25 is an isometric view of a seal that can be used with the containers of Figures 22, 23A, 23B, and 23C.

Figure 26 is an enlarged sectional view of another application of the process path of Figure

1.

Figure 27 is an enlargement of a portion of Figure 27.

Figure 28 is a generic view of another related analyzer having a component substantially similar to the component of Figure 1.

Figure 29 is an illustration of two components of Figure 1 joined together.

Figure 30 is an enlarged view of a portion of Figure 29.

Figures 31A, 31B and 31C show another container for use with the process path of Figure

1.

And Figures 32A and 32B illustrate portions of another embodiment of the process path.

Detailed description of preferred embodiments

The embodiments described herein relate to methods and structures for determining an item of interest in a sample. The element of interest can be an antibody, an antigen, concentrations of the first or last or any other desired element of the sample. In an exemplary embodiment, the item of interest is selected, but not limited to, antibodies to HCV, antibodies to HIV 1 / HIV 2, antibodies to hepatitis B nuclear antigen (HBcAb), carcinoembryonic antigen (CEA), cancer antigen 19 -9 (CA19-9), hepatitis B surface antigen (HBsAb), antibodies to hepatitis B surface antigen (HBsAb), alpha-fetoprotein (AFP), total prostate-specific antigen (total PSA), free PSA, thyroid stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone (FSH), beta human chorioenic gonadotropin (B-hCG), free thyroxine (free T4), free triiodothyronine (free T3), total T4, T3 total, progesterone, testosterone, estradiol, prolactin, vitamin B12 (B12), folate, glycated hemoglobin, and ferritin. The structures and methods can be used in several different configurations.

For reasons of clarity of understanding, the structures and methods will be explained with respect to their use in an immunoassay analyzer that performs approximately 200 determinations of elements of interest in a sample in one hour. It should be noted that the structures and methods can be used in other applications, such as analyzers that make 600, 400, 100, 50, etc. determinations in one hour. Several analyzers can be joined or integrated to satisfy individual needs, such as modifying the number of analyzes performed in a given period of time (production), customizing the elements of interest to be determined, etc. For example, an X number of analyzers making Y determinations in a given hour may be connected such that the connected analyzers make XY determinations in one hour.

It is to be noted that such analyzers perform all item-of-interest determinations in substantially the same way. For example, all steps in the determination process for all items of interest are performed within the same time interval, such as 18 seconds, regardless of the number or type of determinations to be performed with the given analyzer. These analyzers can include common items, such as reagents, disposable items, items, such as fluids and analogs, management technologies, mechanisms for performing determination steps, software, etc.

In other applications, the analyzer may be linked, for example, with a carrier system and analogs, along with supporting hardware and software, such that the analyzer can be used with different analyzers, such as clinical chemistry or hematology analyzers and anaeologists, in the same environment. This conveyor system can move samples between analyzers in such a way that different determinations can be made with respect to a sample. Furthermore, although the operation of the analyzer is described herein with respect to one analyzer only, for the sake of clarity, it should be remembered that multiple analyzers may operate identically or differently, simultaneously or at different times. In addition, steps from one operating method can be combined with steps from another operating method to obtain more operating methods.

IS 2 174 154 T3

As illustrated in Figure 1, the analyzer includes a process path 10. It is understood that there are other elements (not shown), such as fluid management mechanisms, suppliers, and analogs, of the analyzer that support the operation of the process path. Process 10. Although the process path 10 is illustrated in a substantially circular configuration, the process path 10 may assume other configurations, such as linear, serpentine, etc., as desired.

The process path 10 includes a cover 12 and a base 14. The base 14 can be attached to a support frame (Figure 17) and the cover 12 is attached to the base 14. The cover 12 can be a single piece or it can include multiple pieces, sometimes 6. Various elements, some of which are described below, of process path 10 are connected to at least one of cover 12 and base 14. Cover 12 and base 14 include structures, such as holes and analogs, to house some of the elements. In one embodiment, the base 14 has an internal diameter of approximately 64.97 cm (25.58 inches), an outer diameter of approximately 76.40 cm (30.08 inches), and a height of approximately 5.05 cm (1 , 99 inches). Base 14 can be made of any suitable material, such as metal, polymer, and the like. In one embodiment, the base 14 is made of anodized aluminum, including a reduced friction coating, such as an anodized coating impregnated with PTFE. In one particular embodiment, the base 14 is made of 6061-T6 aluminum with a MIL-A63576, Type I finish. The cover 12 can be made of a material that is substantially similar to the material of the base 14.

Figure 2 shows the process path 10 with the cover 12 removed from the base 14. With the cover 12 removed, a disc 16 can be seen. The disc 16 is located between the cover 12 and the base 14 and can be moved with relative to cover 12 and base 14.

In some embodiments, the disk 16 may be replaced by a belt 16 *, shown in Figures 32A and 32B, driven by a wheel 17. The use of the belt 16 * provides orientations other than substantially circular, i.e. serpentine and analogs, process path 10. Belt 16^* moves relative to cover 12 and base 14 in substantially the same way as disk 16. In other respects, the construction of process path 10 is substantially similar regardless of the use of disk 16 or belt 16^* .

Disc 16, illustrated more clearly in Figure 3, has, in one embodiment, an inner radius of approximately 64.0 cm (25.2 inches) and an outer radius of approximately 74.42 cm (29.3 inches). Disc 16 can be approximately 1.6mm (0.063 inch) thick. Disc 16 can be formed of any suitable material, such as a polymer and the like. In one particular embodiment, the disk 16 is made of polyvinyl chloride. Disc 16 can be machined, molded, or the like. In an exemplary embodiment, the material including the disc 16 is chosen relative to the material of the base 14 to reduce friction between the base 14 and the disc 16.

A plurality of slots 18, 112 in the illustrated embodiment are disposed on disk 16. As explained in more detail later, slots 18 cooperate with structures in base 14 to move containers 15 (Figures 7A and 7B) to along process path 10. Each slot 18 has, relative to disc 16 in an exemplary embodiment, a radial length of approximately 4.45 cm (1.75 inches) and a tangential width of approximately 11.43 mm (0.45 inches), with a centerline of grooves 18 in a radius of approximately 34.58 cm (13.614 inches). As further explained below, slot 18 has a longitudinal axis and container 15 is capable of moving within slot 18 along the longitudinal axis of slot 18. To facilitate movement of container 15 along the axis longitudinal of slot 18, process path 10 may include a configuration, such as a surface, diverter, prime mover engageable with container 15, and the like. In another embodiment, one end of slot 18 may include an expanded latitude width (FIG. 13) to facilitate removal of a container 15 from disk 16. In another embodiment, the expanded latitude width may be located in another region of the disk. slot 18 (figure 19).

Disc 16 is configured to facilitate movement of disc 16 relative to cover 12 and base 14. In one embodiment, a plurality of teeth 20 are disposed along an outer diameter surface of disc 16. In an exemplary embodiment, the number of teeth 20 may be about 938 with a diametral pitch of about 32, a pressure angle of about 20 degrees, and a pitch diameter of about 74.45375 cm (29.3125 inches).

As shown in Figure 6, the teeth 20 engage a gear 22 that is driven by a prime mover 24 attached to the base 14 by a bracket 26. In an exemplary embodiment, the gear 22

ES 2 174 154 T3 is made from Estane 58130 natural 92A / 50D polyurethane and motor 24 is a model P21 available from Pacific Scientific of Rockford, Illinois. The prime mover 24, the entire process path 10 and its supporting elements, are connected and operated with a suitable controller, such as a computer (not shown) that executes an appropriate routine and the like. In this manner, disk 16 is moved in response to movement of gear 22 by prime mover 24. In a particular embodiment, prime mover 24 is a stepper motor.

Referring to Figure 4, base 14 includes structures to facilitate the determination of an item of interest in a sample. Base 14 includes at least one track 28 to guide movement of container 15 along process path 10 in response to movement of disk 16. As disk 16 moves in response to activation of prime mover 24, container 15 moves along track 28 from one processing station to another to complete the determination of the element of interest in the sample.

In the illustrated embodiment, there is a first processing track 28 and a loading track 30 in the process path 10. Complementary portions of the tracks 28 and 30 are formed on the cover 12 and base 14. Since these two tracks 28 and 30 are substantially conchoentric, the disc 16, which is adjacent to both tracks 28 and 30, and its grooves 18 are sized to accept and support containers 15 arranged in the process track 28 and the loading track 30 in substantially the same circumferential position, albeit radially offset, on disk 16. In an exemplary embodiment, the tracks 28 and 30 are approximately 3.0866 mm (0.279 inches) wide at the top and have a bank angle of approximately 1.5 degrees.

As shown in Figures 18A, 18B and 18C, in one embodiment, the loading track 30 accepts and orients containers 15 from a supply or hopper 102 of containers 15. A disk 104 including a boss 106 travels within the hopper. 102 by a prime mover 108. In some embodiments, structures such as a deflector to direct movement of containers 15 within hopper 102 in response to movement of disk 104 may be included with hopper 102, an "inherent flat spring" actuated by an associated eccentrically driven mechanism. with disk 104 to move containers 15 within hopper 102, and anaologues, to facilitate movement of containers 15. As disk 104 moves within hopper 102, protrusion 106 is inserted via upper surface 42 of a container 15 into hopper 102. Protrusion 106 carries container 15 toward a loading mechanism 110, which may include a motor. 111, such as a canon and anologue eccentric, for approaching a container 15 from hopper 102 toward loading track 30. As container 15 approaches loading track 30, in one embodiment, another moving device 112, such as a solenoid-driven rod and the like, moves container 15 into a slot 18 in disk 16 on the loading track. 30. Alternatively, the container 15 may be moved from one end of the motor 111 into a slot 18 in the disk 16 on the loading track 30 under the influence of gravity.

In an exemplary embodiment, the hopper 102 is made from Lexan WR2210 (GE Plastics of Pittsfield, Massachusetts) with a black SPI B1 finish and has a volume substantially within the range of about 6489.2 to about 88506 cm.³ (approximately 396 to approximately 540 cubic inches), thereby allowing hopper 102 to hold approximately 1000 containers

fifteen. Disc 104 is made of Lexan 500 with a gray SPI B1 finish and the 106 boss is made of Lexan WR2210 with a black SPI B1 finish. Disc 104 includes four boss assemblies 106 spaced equidistantly along a circumference of disc 104, ie every 90 degrees, within a radius of approximately 11.43 cm (4.5 inches) from a center of disc 102. To assist movement of containers 15 within hopper 102, disk 102 includes a plurality, such as four, of buttons having a spherical radius of approximately 4.191 cm (0.165 inches) spaced equidistantly along a circumference of the disk. 104, that is every 90 degrees, within a radius of approximately 8.412 cm (3.312 inches) from a center of disk 102. The boss 106 has a nominal thickness of about 2.54mm (0.1 inch) and a length of about 22.86mm (0.9 inch). The protrusion 106 was aligned substantially tangentially at a radius of 11.43 cm (4.5 inches) of the disk 102. The motor 108 may be # 78431-101 from Pacific Scientific of Elgin, Illinois. The 111 motor includes a screw made from Delrin 500 that has a black SPI B1 finish. The screw is approximately 18.1 cm (7.126 inches) long and has 18 threads with a diameter measuring approximately 17.9342 mm (0.706 inches) and a pitch of approximately 10.0076 mm (0.394 inches). The screw is connected to a drive gear made of Celcon M90 that has a black SPI B1 finish. The drive gear is an evolving profile gear having 24 teeth with a diametral pitch of approximately 32, a pressure angle of approximately 20 degrees, and a pitch diameter of approximately 19.05 mm (0.75 inches). Engine 112 may be the n^° 78851-102 available from Hayson Switch & Instrument of Waterbury, Connecticut. On

In other embodiments, No. 78425-101 available from SPM / Portland of Hillsboro, Oregon can be used for some of the components.

As shown in Figures 7A and 7B, the container 15 includes a sample receiving chamber 32 and a pair of support surfaces 34A and 34B connected with the sample receiving chamber 32. As shown in Figure 8, the Support surfaces 34A and 34B rest on portions of disk 16 that limit slot 18. Chamber 32 is formed by two sets of side walls 36A, 36B, 38A, and 38B and a bottom wall 40. In an exemplary embodiment, the largest external distance between the side walls 36A and 36B, which have a rib with a width of approximately 0.508 mm (0.020 inch), is approximately 6.604 mm (0.26 inch), the largest external distance between side walls 38A and 38B is approximately 11.176mm (0.44 inch), support surfaces 34A and 34B extend a distance measuring approximately 2.159mm (0.085 inch) from side walls 38A and 38B, respectively, the maximum length of the container 15 is approximately 36.703 mm (1.445 inch), an open end of the sample receiving chamber 32 measures approximately 9.9314 mm (0.391 inch) by approximately 5.5626 mm (0.219 inch), a Nominal wall thickness 36A, 36B, 38A, and 38B is approximately 0.762 mm (0.030 in.), An interior depth of the sample receiving chamber 32 is approximately 34.036 mm (1.34 inches) having a volume of approximately 1.4 ml and a volume of the sample receiving chamber 32 at a position, from which They make the determination measurements, which measures approximately 17.7546 mm (0.699 inch) from the bottom of the container 15 is approximately 0.45 ml. An upper surface 42 of container 15 is located at a distance measuring approximately 4.572 mm (0.18 inch) from support surfaces 34A and 34B. Container 15 can be made from Escorene 3345-E5 (Exxon, Houston, Texas) or Montell PD701N (Wilmington, Delaware) with a polished SPE / SPE 1 B-2 interior finish.

Returning to Figures 4 and 8, the cooperation between container 15, grooves 18 in disk 16, and tracks 28 and 30 facilitate movement of container 15 along process path 10. Specifically, the dimensions of the container 15, the grooves 18, and the tracks 28 and 30 are predetermined such that the support surfaces 34A and 34B of the container 15 radially slidably engage the disk 16 adjacent to the groove 18 in which it will be located. arranged the container 15 while restricting the rotation of the container 15 itself within the slot 18. In one embodiment, the process track 28 has a radius of approximately 70.104 cm (27.6 inches) and a width of approximately 7.112 mm (0.28 inches) while the loading track 30 has a smaller radius, but a similar width. Container 15 is arranged such that sidewall axes 36A and 36B are positioned substantially radially with respect to process path 10 and support surfaces 34A and 34B are substantially circumferentially aligned with respect to process path. process 10. In this manner, when disk 16 moves in response to activation of prime mover 24, container 15 within slot 18 moves substantially tangential to process path 10 within tracks 28 and 30.

When process path 10 can be used with biological samples, it is desirable to maintain process path 10, or portions thereof, at a suitable temperature, such as 37 degrees Celsius, to facilitate determination of the element of interest. Thus, a heater (not shown), such as an electric heater and the like, may be thermally associated with process path 10. In an exemplary embodiment, a plurality of flexible sheet resistive electrical heaters, such as with a suitable adhesive and the like, may be applied to the cover 12 and / or the base 14 of the process path 10. These heaters apply sufficient thermal energy to the process path 10 such that the contents of container 15 are maintained at the desired temperature. Also, since the loading track 30 is part of the process path 10, it is possible to bring the container 15 to the desired temperature before adding something to the container 15. For example, if the determination of an element of interest in a sample is carried out optimally at a given temperature, the container 15 in the loading track 30 can be brought to that given temperature in a certain period of time after the introduction of the container 15 from the hopper to the loading track 30, but before the container 15 has to make the desired determination. Suitable temperature control devices, such as thermistors and analogs, are also provided along process path 10. Additionally, in some embodiments, materials, such as reagents and the like, to be added to container 15 can be heated prior to They add it to the container 15. In some cases, the material supply apparatus, such as a fluid conduit and the like, may be associated with appropriate heaters and thermal sensors.

When a container 15 is needed to perform a determination of a given item of interest, the container 15 moves from the loading track 30 to the process track 28. This function is performed at the position 48 shown in Figure 4. To move the container 15 from loading track

ES 2 174 154 T3 towards the process track 28, as shown in Figure 10, a prime mover 44, mounted on the process path 10, is started. A container 15 latch member 46 operatively connected to prime mover 44 is supported against side wall 36A of container 15 and moves container 15 radially outward relative to disk 16 within slot 18 from loading track 30 toward process track 28 in response to activation of prime mover 44. In an exemplary embodiment, element 46 is made from 6061-T6 aluminum with a MIL-A-63576, Type I finish. Element 46 may include structures, such as a slot, that mate with complementary structures, such as a pin, in prime mover 44 to provide the desired alignment of motor 44 and arm 46 and to limit unwanted movement, such as movement. of element 46. Operation of prime mover 44 causes element 46 to move a distance of approximately

12.7 mm (0.5 inch) with a minimum breakout force of approximately 7.08 / 0.25 g / oz (7.08 g corresponds to 0.25 ounces) and a minimum breaking force of approximately 56, 7 / 2.0 g / oz (56.7 g corresponds to 2.0 ounces).

To accommodate the movement of vessel 15, a passage 50 is formed in cover 12 and base 14 connecting process track 28 with loading track 30. Once vessel 15 is on process track 28, the motor Primary 44 moves container 15 latch 46 away from newly moved container 15 to a standby position to move another container 15 from loading track 30 toward process track 28. In an exemplary embodiment, prime mover 44 is a solenoid, pneumatically actuated motor, linear positioner, or analog. In one particular embodiment, prime mover 44 is an electric solenoid with its windings modified in such a way that advancement of the solenoid occurs without splashing or spilling the contents of container 15.

Now that the container 15 has been moved from the loading track 30 to the process track 28, the movement of the disk 16 causes the container 15 to move along the process track 28 to perform the determination of an element of control. interest in a sample. In some cases, the sample, such as blood or other body fluids, added to the container 15 is in the form of a liquid. In addition, in some cases, other substances, such as reagents and analogs, are added to the sample in container 15 during the determination of an item of interest in the sample. These other substances can also be in liquid form.

When these liquids are added to container 15, some of the liquids may not end up within container 15, but may remain on disk 16 or other portions of process path 10. To substantially remove these liquids, conduits have been provided. drain 52 at the base 14 of the process path 10. These drain ducts 52 are recessed from a slot 54 in the base 14 in which the disc 16 is arranged. In one exemplary embodiment, drain conduits 52, approximately 112 numbered, are equidistantly spaced along a circumference of base 14, are recessed a distance of approximately 3.175 mm (0.125 inch) from slot 54, have a internal angle of approximately 90 degrees and are approximately 1.27 mm (0.05 inch) deep and approximately 4.7625 mm (0.1875 inch) wide. In some embodiments, drain conduits 52 may be sloped toward process track 28 such that liquid within drain conduits 52 will move under the influence of gravity toward and into process track 28. In the illustrated embodiment , the drain conduits 52 are oriented in a direction expected from the rotation of the disc 16. In this embodiment, the movement of the liquid within the drain lines 52 is promoted by the movement of the disk 16. Similar drain lines 52 can be formed in the cover 12. To facilitate substantial removal of the liquids from the process track. 28, drain holes 56 are provided in base 14 at various locations along lower portions of process track 28.

The process of determining an item of interest in a sample includes several steps. However, given the specific element of interest to be determined, different steps have to be taken. For example, for the determination of a first element of interest, three process steps have to be carried out, while for a second element of interest, only two process steps have to be carried out. These process steps may include, for example, separation (eg, magnetic) of solid / liquid phase, aspiration of the contents of container 15, washing of the contents of container 15, etc. To provide determination of both the first and second items of interest, the process path 10 includes structures for the selective automatic performance of the process steps. However, it is to be noted that the process path 10 includes all the structures necessary to perform all the process steps to determine a predetermined set of items of interest.

At least in one position along the process track 28, structures or elements have been arranged for the selective automated realization of an element of interest determination process step.

IS 2 174 154 T3

As shown in Figure 4, in one embodiment, these structures or elements are located in a bypass region of process path 10. In the illustrated embodiment, process path 10 includes three bypass regions 58A, 58B, and 58C. In bypass regions 58A, 58B, and 58C, process track 28 will be radially expanded relative to other portions of process track 28. In an exemplary embodiment, process track 28 in bypass regions 58A, 58B, and 58C is approximately 16.51mm (0.65 inch) in radial width. Radial expansion of process track 28 in bypass regions 58A, 58B, and 58C allows vessel 15 to be positioned in multiple locations longitudinally along slot 18 and radially with respect to disk 16 in bypass regions 58A, 58B and 58C. Depending on the position of the container 15 within the slot 18 in the disk 16, the container 15 may or may not participate in the step of the element of interest determination process performed in the bypass regions 58A, 58B and 58C.

In an alternative embodiment, the structures or elements for the selective automated realization of an item of interest determination process step may include routines, such as those performed in software, hardware and analogs, to selectively activate or deactivate some elements of the path of interest. process 10, such as a wash zone and analogs, selectively inserting and removing elements of process path 10 from a process step performing position relative to process path 10, such as moving a magnet and the like, or any appropriate combination of the methods discussed herein.

Cover 12 also includes structures that form bypass regions 58A, 58B, and 58C in process path 10. As shown in Figures 5A and 5B, a wall in cover 12 separates process track 28 in cover 12. in bypass regions 58A, 58B, and 58C to a process step realization track and a radially offset process step avoidance track in cover 12. The wall engages a portion of the adjacent side walls 36A and 36B of the upper surface 42 of the container 15 to guide the container 15 through the process pass realization track 62 or the process path avoidance track 64.

To push the desired container 15 to the desired track of the process step realization track 62 or the process step avoidance track 64, a prime mover 44 connected with a container latch 46 attached to the path is provided. Process 10, as shown in Figure 9. The structure illustrated in Figure 9 is substantially similar to the construction illustrated in Figure 10, therefore the reference numbers are analogous. Activation of prime mover 44 allows selective radial positioning of container 15 on an inner or outer radial edge (Figures 5A and 5B) of process track 28. Once so positioned, advancement of disk 16 with respect to base 14 moves the container 15 to the preselected track of the process step realization track 62 or the process step bypass track 64.

In some embodiments, prime mover 44, and / or wall 60 may be constructed to take advantage of the natural movement of vessel 15 on process track 16. For example, vessel 15 may tend to move radially outward along process track 28. In this case, the prime mover 44 and / or wall 60 can be constructed in such a way that a container 15 moved toward the process step avoidance track 64 moves toward said track 64 under centrifugal force without any assistance from the prime mover. 44. In this case, the prime mover 44 will only act on a container 15 to be moved to the process step realization track 62.

In the illustrated embodiment, bypass regions 58A, 58B, and 58C will be located along process track 28 depending on the anticipated frequency of performance and avoidance of a particular process step. In turn, this frequency depends on a particular step of the determinations of elements of interest to be carried out with the process path 10. Furthermore, depending on the determinations to be made, more or less bypass regions 58A, 58B and 58C can be provided.

Illustrated better with an example, process track 28 diverges radially before entering bypass region 58A (Figures 5A and 5B). Process track 28 enters bypass region 58A along its outer radial edge. Since the process step realization occurs in the process step realization inner track 62 of the bypass region 58A, the prime mover 44 associated with the bypass region 58A moves the container 15 radially inward toward the bypass track. perform process step 62 only if you want to perform this process step. If performance of this process step is not desired, prime mover 44 will not be activated and container 15 will remain on the outer radial surface of process track 28 and move to process step avoidance track 64 upon movement of the disk 16. This construction favors the realization of a set of determinations where the realization of the relevant process step is required for the least part of

ES 2 174 154 T3 the determinations to be made.

If the set of determinations had to be changed in such a way that the relevant process step is required for most of the determinations to be made, it may be desirable to construct the bypass region 58A substantially the same as the bypass regions 58B. and 58C. In bypass regions 58B and 58C, process track 28 enters bypass regions 58B and 58C at its inner radial edge. Thus, if the prime mover 44 was not activated, the container 15 moved under the influence of the movement of the disk 16 to the process step performing track 62 and the process step was performed. The prime mover 44 was activated only to move the vessels 15 which did not require the completion of this process step. Naturally, this represented the least part of the determinations to be made with process path 10.

Once a container 15 is in one of bypass regions 58A, 58B, or 58C, movement of container 15 through bypass region 58A, 58B, or 58C is controlled by cooperation between disk 16, the edges of process step realization and avoidance tracks 62 and 64 and wall 60. Container 15 moves substantially tangentially through process path 10 under the influence of the rotation of disk 16. The position of the container 15 radially within the radially inner track of the process step realization track 62 (for example, the bypass region 58A) or the process step avoidance track 64 (for example, the bypass region 58B) is held by an inner radial edge of wall 60. A radius defining this inner radial edge of wall 60 gradually increases along wall 60 from a first end 70 to its second end 72. Vessel 15 moves radially outward as vessel 15 travels through bypass region 58A, 58B, or 58C. A radius defining an inner edge of the process step realization track 62 (for example, bypass region 58A) and process step avoidance track 64 (for example, bypass region 58B) also increases from one end of bypass region 58A, 58B, or 58C adjacent to first end 70 of wall 60 to an opposite end of bypass region 58A, 58B, or 58C adjacent to second end 72 of wall 60. Thus, a portion of container 15 adjacent to its top surface 42 remains adjacent to wall 60, thereby maintaining the intended placement of container 15 within bypass regions 58A, 58B, and 58C.

After the determination of an item of interest is finished, the relevant container 15 is removed from the process track 28 and the process path 10. As shown in Figure 11, a prime mover 74 was connected to the process path. Process 10. Prime motor 74 drives a container 15 engaging surface 76 which acts on container 15 adjacent to upper surface 42 of container 15. Prime motor 74, which may be a stepper motor and the like, moves container engaging surface 76 to rotate container 15 approximately 90 degrees relative to the disk.

16. This occurs at position 78 shown in Figure 4. Process path 10 at position 78 is configured to allow axial rotation of container 15 and includes a hole 80 having dimensions larger than the corresponding dimensions of container 15.

In an exemplary embodiment, prime mover 74 may be a solenoid such as P / N 197855-001 BTA 2 DV 90 * available from Lucas Control Systems Products of Vandalia, Ohio. Surface 76 can be made from 6061-T6 aluminum with a MIL-A-63576, Type I finish and moves approximately 90 degrees in response to operation of prime mover 74.

Once the container 15 has been rotated, the support surfaces 34A and 34B of the container 15 are no longer in engagement with the disk 16. Under the influence of gravity, the container 15 falls through the hole 80 in the process path 10 to a waste container (not shown). In some constructions, a chute may be provided to guide container 15 from process path 10 to the waste container. In other constructions, liquid present in container 15 can be removed from container 15 prior to meeting prime mover 74.

With container 15 removed from process track 28, another container 15 within the same slot 18 on disk 16 can be moved from loading track 30 to process track 28 as soon as the relevant slot 18 reaches the position 48. In some cases, it may not be desirable to remove a container from process track 28 once container 15 reaches position 78. In this case, prime mover 74 was not activated. Furthermore, a container 15 disposed within the same slot 18 on the disk but on the loading track 30 did not move from the loading track 30 to the process track 28 when the relevant slot 18 reaches position 48.

In an alternative embodiment shown in Figures 13 and 19, disk 16 is constructed to facilitate removal of a container 15 from process path 10. In this embodiment, the grooves 18 in the

The disk 16 includes an enlarged extraction zone 82 of the container 15. In addition, a diverter 84 is arranged in the process track 28 adjacent to position 78. The diverter 84, along with the movement of the disk 16, pushes container 15 radially outward with respect to disk 16 toward container extraction zone 82 of groove 18. Container extraction zone 82 is wider than the rest of slot 18 such that when container 15 reaches container extraction zone 82 from slot 18, gravity causes container 15 to fall off the disk. 16 and process path 10 through hole 80 and into the waste container. However, this embodiment does not allow a container 15 to move to position 78 and still remains with disk 16. But, if it were desirable to allow container 15 to remain with disk 16 in this embodiment, then diverter 84 can be replaced with a prime mover, similar to prime mover 44, to move container 15 into slot 18 toward the zone. container extraction 82.

Another construction of disk 16, groove 18, and container removal zone 82 is depicted in Figure 19. This construction operates in a manner substantially similar to that of Figure 13. It should be noted that, in the embodiment illustrated in FIG. Figure 19, one end of process track 28 is defined by hole 80.

Additional features can be incorporated into the process path 10 as desired. For example, liquid level sensing devices, such as radio frequency and analog liquid level sensing devices, may be incorporated at locations along process path 10 where liquid movement may occur. In addition, any suitable structures can be added, such as any of those described in US Patent Nos. 5,358,691, 5,536,471, and 5,482,861, sometimes with appropriate modifications. Said patents have been assigned to the assignee of the present case.

It may also be desirable to construct process track 28 to reduce light in portions of process track 28. In one embodiment, process track 28 is constructed such that there is radial divergence from process track 28 before and after any position in process path 10 where light measurements are made, such as chemiluminescently generated light. Such radial divergence of the process track 28 can increase the sensitivity of the light meter by reducing the introduction of diffuse or ambient light to the light measurement position of the process track 28.

The process path 10 described above allows the automatic sequential realization of multiple steps of the process of determining the item of interest. The movement of a container 15 along the process track 28 can be performed in discrete steps, that is, discrete with respect to time and with respect to position along the process track 28. At regular intervals of time, such as approximately 18 seconds, the disk 16 rotates a distance substantially equal to the angular distance between two adjacent grooves 18. This rotation causes each container 15 to move to position along the previously occupied process path 10. through the container 15 into the adjacent slot 18. Disc 16 and container 15 remain stationary for the remainder of the regular period of time before the next rotation or indexing of disc 16. Process track 28 can be considered to have a fixed number of process positions, positions in which A process step occurs including the determination of an element of interest in a sample, equal to the number of grooves 18 in disk 16.

In the examples described herein, there are 112 slots 18 in disk 16, and consequently process track 28 can be considered to have 112 process positions. The total processing time of a container 15 and its content can be considered to be integral multiples of the indexing period. For example, if the indexing period is 18 seconds, a container 15 in the 10th process position has undergone a total of 180 seconds of processing. Similarly, a process step that is carried out in 20 process positions takes a total of 360 seconds of process time in an individual container 15.

An example of the process steps that can be performed during the determination of an item of interest in a sample can be described by specifying the process position in which each process step occurs, as is done in the following examples. This example can be more easily understood with reference to Figure 16. The dashed line 129 indicates a boundary of a support on which the process path 10 was mounted.

A reagent carousel 131 is positioned substantially concocentrically with process path 10 and can rotate. The reagent carousel 131 can include one or more carousels and can perform axial rotation of individual vessels, i.e., magnetic microparticle vessels,

ES 2 174 154 T3 arranged in them. In one embodiment, reagent carousel 131 may include multiple substantially concentric carousels to provide simultaneous and / or shared access of multiple vessels by multiple pipette assemblies, such as assemblies 128 and 134. Such an arrangement may facilitate the performance of the formats discussed. more ahead. The reagent carousel 131 can be constructed substantially the same as the structure described in GB 2,081,118B issued September 7, 1983, with appropriate known bearings and gear trains provided as and where necessary (see Figure 24B), such as it is described on page 3, lines 86-91 of said patent. In an exemplary embodiment, carousel 131 may be # 77829-101 available from SPM / Portland of Hillsboro, Oregon, with appropriate motors available from Pacific Scientific, Turnamatic gears of Richardson, Texas, and SPM / Portland and Aromat sensors from Rolling Meadows, Illinois.

The reagent carousel 131 can be kept within a thermostaotically controlled environment. The thermostatically controlled environment can be accomplished by an air cooling unit that provides cold forced air to a box 133 (Figures 29 and 30) containing the reagent carousel 131. In an exemplary embodiment, box 133 can be similar to box 133.^° 76848 available from General Pattern of Blaine, Minnesota. This can reduce the evaporation of fluid from the containers held in the reagent carousel 131. To further reduce evaporation, the open mouths of the containers may be provided with a seal 184 as shown in Figure 25. The seal 184 can be made of a polymeric material, such as an elastoomer and analogs, and can include a slit 186 for a pipettor to access the interior of the container.

In one embodiment, reagent carousel 131 supports a plurality of reagent containers. These containers can be of at least four types, such as microparticle, conjugate, specific diluent for determination and pretreatment, depending on the type of reagent they contain. Figures 22, 23A, 23B and 23C give two exemplary container configurations. A lower portion 174 of canisters 176 (FIG. 22) and 177 (FIGS. 23A, 23B, and 23C) is constructed to mate with mating portions of reagent carousel 131.

As most clearly shown in Figures 24A and 24B, the lower portion 174 of the container 177 supports a protrusion 178 which engages a complementary portion 188 of the reagent carousel 131. The engagement between the projection 178 and the portion 188 of the reagent carousel 131 provides the user who is placing the container 177 on the reagent carousel 131 with positive feedback, that is, tactile feel, indicative of the correct positioning of the container 177 with respect to the carousel 131.

As shown in FIG. 24B, the portion 188 of the carousel 131 was operatively connected by a shaft 191 with a drive gear 190 which drive engages a gear 202 that is connected to a prime mover (not shown). Gear 202 engages all drive gears 190 associated with carousel 131. Operation of the prime mover drives gear 202 which, in turn, drives gear 190. Movement of gear 190 produces axial rotation, which may be bi-directional, of portion 188 and container 177. Shaft 191 also electrically contacts a plate 204 that is electrically connected to conductor 206. In this way, the plate 204 and the conductor 206, and possibly the portion 188 of the carousel 131, if it is an electrical conductor, include a portion of a radio frequency liquid level detection mechanism that determines the level of fluid within the container 177. .

To further facilitate handling of container 177, a substantially annular rib 180 (Figures 23A, 23B, and 23C) may be provided on an outer surface of container 177. Furthermore, if it is desirable to maintain the contents of the container in a substantially homogeneous state, that is, magnetic particles dispersed substantially uniformly in a liquid medium, at least one fin 182 (Figures 24A and 24B) may be provided on an interior surface, facing the fluid, of the container 177 to agitate the contents of the container to the axial rotation, discussed above, of the container 177.

Illustrating container constructions and seals with specific examples, containers can be made from DOW 30460M HDPE or Chevron 90512 HDPE with a SPI C1 finish. Fins 182 may be finished to SPI C1. The seals can be made from Lexington Medical 3401005 EPDM. The vessels may have an inside neck diameter measuring approximately 27.1576 mm (1.069 inch). The rib may have a thickness of approximately 0.635 mm (0.025 inch), a width, from an internal wall of the container, that measures approximately 7.874 mm (0.31 inch), a top geometry that measures approximately 45 degrees, and a bottom geometry tapering to a center at an angle of approximately 48 degrees. The seal may have a diameter of approximately 27.7876 mm (1.094 inch) when installed with a container, a maximum thickness of approximately 1.778 mm (0.070 inch) on a central lining of the seal.

ES 2 174 154 T3 watertight, and a reinforced hinged section measuring approximately 0.635 mm (0.025 inch) thick by approximately 1.5748 mm (0.062 inch) deep from a bottom side of a pipettor contact zone on the seal . The slit in the seal may include two slits that are approximately 12.7 mm (0.5 inch) in length across the center of the seal and offset approximately 90 degrees from each other.

To facilitate the identification of the containers, at least some of the containers may carry a label 133A, 133B or 133C, substantially similar to those shown in Figures 21A, 21B and 21C. Labels 133A, 133B, and 133C include a high-density data carrier 135A, 135B, and 135C, respectively, which includes information to facilitate determinations.

In a specific embodiment, the high-density data carrier 135A, 135B, and 135C is a two-dimensional barcode that uses PDF 417 technology to provide the desired data capacity. This technology allows the inclusion of more information than a common one-dimensional bar code. The use of such high-density data carrier 135A, 135B and 135C provides structural flexibility, that is, individual containers for a given determination do not have to be physically linked. The data carrier 135A, 135B and 135C contains information that is desirable for making a given determination. This information may include the main lot number, container lot number, container content, i.e. reagent, lot number and expiration date, calibration curve data, type of container content, etc. The information may also contain a serial number specific to the particular vessel to facilitate tracking of process path 10 resources.

In the illustrated embodiment, data carrier 135A is used with magnetic microparticle containers and contains approximately 185 characters of information. Data carrier 135A is approximately 38.1 mm (1.5 inches) high and approximately 19.05 mm (0.75 inches) wide, as seen by the barcode reader. Since the microparticle container is rotated as explained above, this rotation can be used at the same time as the data carrier 135A is read. In this case, the orientation of the data carrier 135A with respect to the barcode reader may not be important.

Data carriers 135B and 135C of the illustrated embodiment include two dimensional bar codes each containing approximately 15 characters of information. The data density of the 135B and 135C media is adjusted to allow the 135B and 135C media to be approximately 17.78 mm (0.7 inch) tall. In addition, the 135B and 135C data carrier is printed with error correction, X bar, Y bar, and a column count that allows the 135B and 135C carrier to be approximately 7.9375 cm (3.125 inches) wide. In this manner, data carrier 135B and 135C can be arranged along an outer circumference of a container such that carrier 135B and 135C is accessible to the barcode reader at approximately 220 to approximately 270 degrees of visibility. , depending on the size of the container. Alternatively, instead of carrier 135B that includes only one barcode, data carrier 135C includes a plurality of repeats of a similarly shaped, but narrower barcode, with intervals between adjacent code repeats. Additionally, various modifications of the data carriers 135A, 135B and 135C are also possible. For example, one-dimensional bar code could be used, but the surface area of ​​the one-dimensional bar code would have to be sufficient for the amount of data contained in the two-dimensional bar code.

Example

Determination of an element of interest in a sample

The process path 10 illustrated in Figure 1 is used to perform a sequence of process steps, executed with an indexing period of approximately 18 seconds. Each indexing step includes approximately 1 second of rotation of disk 16 (and consequent movement of containers 15 disposed within disk 16) and approximately 17 seconds during which containers 15 are stationary in their respective process positions. The process step performed at each process position is as follows:

IS 2 174 154 T3

<td></td><td>Process position</td><td>Step of process</td><td>Description</td>

<td> 5</td><td> 1</td><td>Container loading fifteen</td><td>Vessel 15 moves from loading track 30 to process track 28 as required</td>

<td> 10 15 20</td><td> 1</td><td>Sample pipettor</td><td>The sample is deposited into container 15 by pipetting system 128. The sample can be obtained from the position 130A or 130B that are located on appropriate conveyors, sample handlers, or structures associated with a laboratory automation system</td>

<td> 25</td><td> 2</td><td>Reagent pipettor 1</td><td>Reagent is obtained from reagent carousel 131 deposited in container 15 by pipetting system 132. Liquid present in pipetting system 132 can also be added to container 15.</td>

<td> 30</td><td> 3</td><td>Mixer</td><td>The content of the container 15 is mixed by a device 86 which imparts movement to the vessel 15</td>

<td> 35</td><td> 4-23</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature, approximately 37 degrees Celsius</td>

<td> 40</td><td> 24</td><td>Sample pipettor</td><td>The sample can be drawn from container 15 by pipetting system 128 for deposition into a second container 15 at position 1</td>

<td> 45</td><td> 25-39</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 50</td><td> 40</td><td>Beginning of the bypass region 58A</td><td>Container 15 is selectively positioned at the entrance to embodiment track 62 or bypass track 64 of bypass region 58A</td>

<td> 55</td><td> 41</td><td>Washing zone 1</td><td>Container 15 located on runway 62 undergoes magnetic separation and fluid addition</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 42</td><td>Washing zone 1</td><td>Container 15 located on track 62 undergoes magnetic separation, aspiration of container 15 contents, and fluid addition.</td>

<td> 43</td><td>Washing zone 1</td><td>Container 15 located on track 62 undergoes magnetic separation, aspiration of the contents of container 15, and addition of fluid.</td>

<td> 44</td><td>Washing zone 1</td><td>The container 15 located on the embodiment track 62 undergoes magnetic separation and aspiration of the contents of the container 15</td>

<td> 45.5</td><td>End of bypass region 58A</td><td>They join the track of realization 62 and avoidance track 64 of bypass region 58A (midway between positions 45 and 46)</td>

<td> 46</td><td>Loading of container 15 on loading track 30</td><td>New containers 15 are loaded onto loading lane 30</td>

<td> 48</td><td>Reagent pipettor 2</td><td>Reagent is selectively deposited into container 15 by pipetting system 134</td>

<td> 49</td><td>Mixer</td><td>The content of the container 15 is mixed by a device 86 which imparts movement to the vessel 15</td>

<td> 50-62</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 63</td><td>Regioán de derivacioán 58B</td><td>Container 15 is selectively positioned at the entrance to embodiment track 62 or avoidance track 64 of bypass region 58B</td>

<td> 64</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 experiences magnetic separation and fluid addition</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 65</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 66</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 67</td><td>Washing zone 2</td><td>Container 15 on runway 62 experiences magnetic separation and aspiration of the contents of container 15</td>

<td> 68</td><td>End of the bypass region 58B</td><td>Realization and avoidance tracks 62 and 64 of bypass region 58B join</td>

<td> 69-70</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 71</td><td>Reagent pipettor 2</td><td>reagent is selectively deposited into container 15 by pipetting system 134</td>

<td> 72</td><td>Mixer</td><td>The contents of container 15 are selectively mixed by a device 86 that imparts movement to container 15</td>

<td> 73-86</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 75</td><td>Motor / encoder</td><td>Gear 22 on prime mover 24 engages teeth 20 on disk 16 in this position</td>

<td> 81.5</td><td>Start sensor</td><td>There is an electrical, magnetic, optical or other sensor 136 to generate a signal corresponding to the position of the disk 16</td>

<td> 86</td><td>Regioán de derivacioán 58C</td><td>Container 15 is selectively positioned at the entrance to realization track 62 or avoidance track 64 of bypass region 58C</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 87</td><td>Washing zone 3</td><td>Vessel 15 on runway 62 undergoes magnetic separation and fluid addition</td>

<td> 88</td><td>Washing zone 3</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 89</td><td>Washing zone 3</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 90</td><td>Washing zone 3</td><td>Container 15 on runway 62 undergoes magnetic separation, and aspiration of the contents of container 15</td>

<td> 91</td><td>End of the bypass region 58C</td><td>Make and avoid tracks 62 and 64 of bypass region 58C join</td>

<td> 91-93</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 94</td><td>Pre-starter and mixer</td><td>Reagent is added to the container 15 and mechanically mixed</td>

<td> 95-97</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 98</td><td>Shutter, Reader, and Launcher</td><td>The indicator reaction (such as chemiluminescent reaction) is started and read with magnetic particles pulled out of solution with an magnet. The shutter blocks ambient light.</td>

<td> 99</td><td>Imóan</td><td>The magnetic particles are held on a wall of the container 15</td>

<td> 100</td><td>Aspirated from residue liquid</td><td>The magnetic particles are held on one wall of the container 15 and all the liquid in the container 15 is sucked up and disposed of.</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 110</td><td>Vessel discharge fifteen</td><td>Container 15 is selectively removed from process track 28</td>

<td> 111</td><td>Container discharge sensor fifteen</td><td>The system optically verifies that the slot 18 in the process track 28 is free before loading the second container 15.</td>

Increasing the specificity of the example, in a specific embodiment, the determination of an element of interest in a sample is an immunoassay. When process path 10 is used to perform an immunoassay, vessel 15 moves to process path 28 at position 1. Also at position 1, a known quantity of sample is deposited (for example, 50 μ! Of blood) into container 15 with a pipetting system 128. Pipetting system 128 includes a pipettor, which may be substantially similar to pipettors 116A, 116B, and 116C, mounted on an arm for up and down and angular movement, as shown in Figure 16.

After the container 15 is indexed to position 2, a known quantity of a first reagent is deposited into the container 15, possibly along with an amount of fluid present in the pipetting system 132, by a second pipetting system 132. The first The reagent may contain magnetically sensitive microparticles coated with antibodies or other binding substances that specifically bind to the element of interest in the sample. A specific assay diluent can be added to the first reagent. In some cases, the first reagent and a conjugate, possibly along with an amount of fluid present in pipetting system 132, can be added at position 2.

At position 3, a mechanical device 86 (illustrated in FIG. 12) is provided to mechanically move container 15 and produce mixing of the contents of container 15. Mechanical mixer device 86 includes a hole 88 formed within a body 89, which is eccentrically formed in the illustrated embodiment, which moves axially and rotationally under the influence of a prime mover 90 connected to the body 89. When prime mover 90 is activated, body 89 rotates clockwise, and a protrusion 92 connected to prime mover 90 moves into a slot 94 in a second body 96. Second body 96 rotates freely about an axis of rotation. prime mover drive 90.

As projection 92 moves into slot 94, body 89 and hole 88 move toward bottom 40 of receptacle 15 as body 89 rotates. When body 89 and hole 88 move toward container 15, hole 88 engages bottom 40 of container 15 and imparts orbital (but not rotary) motion to bottom 40 of container 15. Portions of container 15 adjacent top surface 42 remain relatively stationary within slot 18 in disk 16.

The mechanical movement imparted to container 15 mixes the sample with the first reagent. After the contents of container 15 have been mixed for a predetermined period of time, prime mover 90 rotates its drive shaft counterclockwise, causing projection 92 to move in the opposite direction within slot 94, thereby moving the shaft away. first body 89, hole 88 and second body 96 of bottom 40 of container 15.

Better illustrated with a specific example, in one embodiment, body 89 is made of PEEK with a black finish, boss 92 is made of AISI 301 stainless steel with a # 10 passivated finish, second body 96 is made of Acetron GP with a white finish and groove 94 is finished n^° 32. The hole 88 in the body 89 is offset from an axis of the body 89 and has a radius of approximately 0.508 mm (0.020 inch). An interface between the body 89 and the container 15 provides a minimum of about 1.27 mm (0.05 inch) of eccentric rotation of the container 15. The slot 94 provides an increase of about 8.001 mm (0.315 inch) over a rotation of the second body 96 of approximately 226.8 degrees. Prime motor 90 is a brushless motor

IS 2 174 154 T3

Y-Connected 8 Pole 3 Phase DC P / N DR538-504 available from Shinano Kenshi of California. Prime motor 90 receives a potential of 36 volts and operates substantially within the range of about 500 to about 5500 rpm with a constant torque of about 620 g * cm / A.

Container 15 is released from hole 88 and processing of the contents of container 15 continues. The contents of container 15 are then incubated for a predetermined period of time.

At position 24, depending on the particular element of interest in the sample to be determined, the first pipetting system 128 can remove a portion of the contents of container 15 to deposit it in another container 15 located at position 1. This may be appropriate when a particular determination requires pretreatment, such as preheating, heated incubation with a first reagent prior to introduction of a second reagent, and analogous, prior to introduction of magnetically sensitive microparticles including the first reagent.

At position 37, process path 10 selectively positions container 15 to perform or avoid a series of steps of magnetic separation and washing. Structures for performing the washing and separation include a washing station 114, shown in Figures 14 and 15.

Each wash station 114 includes a plurality, 3 in the illustrated embodiment, of mobile pipettors 116A, 116B, and 116C and at least one stationary nozzle (not shown) for introducing at least one fluid into and out of the container 15. In some embodiments , the mobile pipettors 116A, 116B and 116C can be used to draw fluids from container 15 while the at least one stationary nozzle introduces fluid into container 15. Sensors, such as thermistors and analogs, can be operatively associated with pipettors 116A, 116B, and 116C to verify fluid movements.

Pipettors 116A, 116B and 116C draw liquids into and out of container 15 while the nozzle only draws liquid into container 15. Mobile pipettors 116A, 116B and 116C are connected to a common base plate 118 that moves relative to the cover. 12 under the influence of a prime mover 120, such as a stepper motor and analogs. In response to prime mover 120, pipettors 116A, 116B, and 116C enter and exit container 15. Suitable fluid supply lines, not shown, are connected to pipettors 116A, 116B, and 116C and the mouthpiece. Pipettors 116A, 116B, and 116C are spring biased to facilitate replacement and cushion any contact between pipettors 116A, 116B, and 116C and other surfaces, such as the bottom 40 of container 15 and the like.

The pipettors 116A, 116B, and 116C can be moved to draw fluid from the container 15. Since the item of interest is connected to the magnetic particles, a magnet assembly 122 is also included in the wash station 114. The magnet assembly 122 is disposed in a receptacle 124 in base 14. Magnet assembly 122 includes a portion of the performance track 62 and holds a plurality of permanent magnets 126. In an exemplary embodiment, assembly 122 is made of 6061 T6 aluminum with a finish of MIL-A-63576 Type I and magnets 126 are neodymium iron boron (NdFeB) magnets with a residual flux density (Br) substantially within the range. range of about 12.1 to about 13.2 kg, a coercive force (Hc) substantially within the range of about 11.0 to about 12.0 KOe, an intrinsic coercive force (Hci) substantially within the range of about 17.0 to about 19.0 KOe and a total energy product (BHmax) substantially within the range of about 34.0 to about 41.0 MGOe. The field strength of magnets 126 at a distance of about 0.762 mm (0.030 inch) from container 15 is about 4470 gauss and at a distance of about 4.470 mm (0.176 inch) from container 15 is about 1570 gauss.

At the wash station 126, the magnets 126 retain the magnetic particles, and therefore the item of interest, against a side wall 36A or 36B of the container 15. This allows the extraction of the contents of the container 15 other than the magnetic particles and the element of interest attached to the magnetic particles. In some constructions, pipettors 116A, 116B, and 116C can be positioned such that pipettors 116A, 116B, and 116C travel substantially along a central axis of elongation of container 15, can be offset from a side wall 36A, or 36B against which magnetic particles are retained, or otherwise constructed to reduce the chances that pipettors 116A, 116B and 116C remove 15 magnetic particles and the element of interest attached to the magnetic particles from the container.

IS 2 174 154 T3

In an exemplary embodiment, pipettors 116A, 116B, and 116C are made from Inconel. Pipettors 116A, 116B, and 116C are arranged such that the central longitudinal lines of pipettors 116A, 116B, and 116C are offset by a distance measuring approximately 0.7366 mm (0.029 inch) from a center line of vessels 15 in the tubes. that pipettors 116A, 116B and 116C are introduced. This deflection moves the pipettors 116A, 116B, and 116C away from the magnetic particles within the vessels 15. When the pipettors 116A, 116B, and 116C dispense fluid to the vessels 15, the pipettors 116A, 116B, and 116C are positioned at a distance that measures approximately 8.6868 mm (0.342 inch) from a side wall of the vessels 15 adjacent to the magnets 126. Pipettors 116A, 116B and 116C are spring mounted to absorb up to 2.54 mm (0.1 inch) of overdrive. Pipettors 116A, 116B, and 116C are fluidly connected with a valve that allows bubble discharge without the use of a container 15. The stationary nozzle is made of 0.7874 mm (0.031 inch) inner diameter PEEK tubing. Baseplate 118 is a two-piece, thermally bonded assembly of acrylic with a clear Iridite finish on top and an opaque finish on the bottom to allow for fluid visibility and light shielding for a chemiluminescence reader.

If, for a particular determination, magnetic separation and flushing is required at position 37, container 15 is moved to runway 62. Containers 15 on runway 62 undergo, at each processing position between 41 and 44, magnetic separation (effected by permanent magnets 126 in fixed positions adjacent to runway 62), aspiration of fluid, and dispensing of fluid, made by fluid handling devices introduced through a hole 98 (figure 1) in the cover 12. In one embodiment, one of these wash stations (position 41) includes only a magnetic separation and fluid dispensing step that introduces a wash buffer into the container 15. In some cases, the wash buffer or other fluid is added from such that the amount of fluid present within container 15 facilitates (magnetic) separation of the fluid particles in container 15. Separation, fluid aspiration, and fluid dispensing occurs at positions 42 and 43. At position 44, the magnetic particles are separated from the fluid in container 15 by magnets 126 and fluid is aspirated. In this example, these steps will remove substantially all substances within container 15 that have not bound to binding conjugates on the magnetic particles deposited as the first reagent. Containers 15 within avoidance track 64 are not disturbed and incubation continues. The realization and avoidance tracks 62 and 64 are joined between positions 45 and 46.

A second reagent can be deposited into container 15 at position 48 (Figure 4) by a third pipetting system 134, followed again by a mechaonic device 86 at position 49 to mix the contents of container 15. The second reagent can include an indicator substance, such as a chemiluminescent substance, bound to binding elements that also bind to the element of interest (the remaining appearances of which bind to the magnetic particles of the first reagent). The contents of container 15 are incubated at positions 50-59.

The second bypass region 58B begins at position 60, where container 15 can selectively automatically undergo a set of magnetic separations, fluid aspirations, and fluid dispensing steps.

The third pipetting system 134 can deposit a third reagent into container 15 at position 71, with subsequent mixing at position 72 and incubation between positions 73 and 86.

The third bypass region 58C begins at position 86, where container 15 can selectively automaotically undergo a set of magnetic separations, fluid aspirations, and fluid dispensing steps.

In one embodiment, where it is assumed that substantially a greater portion of the containers 15 experienced magnetic separation, fluid aspiration, and fluid dispensing at positions 87-90, no bypass region 58C can be arranged at these positions. For example, these steps lead to the extraction of substantially all the indicator substances (chemiluminescent) that are not bound to the magnetic particles (by the analyte of interest), obtaining a container 15 containing indicator substance in an amount indicative of the amount of the element. of interest in the deposition of the initial sample. However, in some determinations, it is desirable to avoid process steps.

A pre-start reagent can be deposited by a fluid dispensing device at position 94.

IS 2 174 154 T3

A fluid dispensing device will deposit an initiating agent at position 98, causing the indicator reaction to occur. For example, a chemiluminescent release reagent may be deposited at position 94, which causes release of the reporter (chemiluminescent) substance from the magnetic particles.

The contents of container 15 are incubated between positions 95 and 97, inclusive.

Position 98 may also include a magnet, which separates or removes substantially all magnetic particles from the fluid within container 15. The magnet retains substantially all magnetic particles against a side wall 36A or 36B of container 15 prior to reading light from the chemiluminescent substance. Preferably, all the magnetic particles are taken from a chemiluminescent photon path of the chemiluminescent substance, which remains in solution in the fluid in container 15, to a light detection apparatus 138. This reading step is substantially similar to that described in EP 0 371 265 B1 issued January 1, 1994. The introduction of the initiating reagent will initiate a chemiluminescent reaction that will be detected and quantified by an optical detection system (not shown) such as a photomultiplier tube or photon counting system.

In an exemplary embodiment, apparatus 138 may include a reader assembly such as n^° 78262 available from Thorn Emi of Rockaway, New Jersey, a photomultiplier tube such as n^° 78252-101 available from Hammamatsu of Middlesex, New Jersey, and a substantially light tight shutter operable by a piston such as n^° 78200-101 available from Ironwood Industries of Libertyville, Illinois, and an engine such as n^° 78851-101 available from Hayson Switch &amp; Instrument of Waterbury, Connecticut.

The embodiment described in the following examples demonstrates its usefulness in processing multiple assays of different formats and timing requirements within a common process path 10. In these examples, the described embodiment allows the execution of at least the following four assay formats, of which the first three can be executed simultaneously without degradation of the processing capacity.

Format A

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (18 minutes)</td><td> 4-63</td>

<td>Separation and washing</td><td> 64-67</td>

<td>Introduction and mixing of a second reagent</td><td> 71-72</td>

<td>Second incubation (4 minutes)</td><td> 73-86</td>

<td>Separation and washing</td><td> 87-90</td>

<td>introduction and mixing of the pre-initiator</td><td> 94</td>

<td>Third incubation (1 minute)</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

For example, format A can be used to determine at least the following items of interest: HCV Antibodies, HIV 1 / HIV 2 Antibodies, Hepatitis B Nuclear Antigen (HBcAb), Carcinoembryonic Antigen (CEA), Cancer 19-9 Antigen (CA19-9), Hepatitis B Surface Antigen (HBsAb) , antibodies to hepatitis B surface antigen (HBsAb), alpha-fetoproteon (AFP), total prostate-specific antigen (total PSA), free PSA, thyroid stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone ( FSH), Human chorionic gonadotropin beta (B-hCG), free thyroxine (free T4), free triiodothyronine (free T3), total T4, total T3, prolactin and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. For example, this format can also be used to determine beta human chorionic gonadotropin (B-hCG), prolactin, and ferritin.

IS 2 174 154 T3

Format B

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-40</td>

<td>Separation and washing</td><td> 41-44</td>

<td>Introduction and mixing of a second reagent</td><td> 48-49</td>

<td>Second incubation (11 minutes)</td><td> 50-86</td>

<td>Separation and washing</td><td> 87-90</td>

<td>Introducing and mixing the pre-initiator</td><td> 94</td>

<td>Third incubation (1 minute)</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

Format B can be used, for example, to determine an element of interest in a sample where a relatively higher degree of sensitivity is desired, compared to other formats. It should be noted that almost any element of interest explained here can be determined using this format correctly.

Format C

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-40</td>

<td>Separation and washing</td><td> 41-44</td>

<td>Introduction and mixing of a second reagent</td><td> 48-49</td>

<td>Second incubation (4 minutes)</td><td> 50-63</td>

<td>Separation and washing</td><td> 64-67</td>

<td>Introduction and mixing of the third reagent</td><td> 71-72</td>

<td>Third incubation (4 minutes)</td><td> 73-86</td>

<td>Separation and washing</td><td> 87-90</td>

<td>Introducing and mixing the pre-initiator</td><td> 94</td>

<td>Fourth incubation (1 minute)</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

Format C can be used, for example, when the item of interest refers to hepatitis, such as determinations for anti-M, HBcAb-M and HAVAb-M.

Format D

Step Position

Introduction of sample 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer to the second container 15 at position 1 24

Introduction and mixing of a second reagent 2-3

Second incubation (11 minutes) 4-40

Separation and washing 41-44

Introduction and mixing of the third reagent 48-49

ES 2 174 154 T3 (Continued)

<td>He passed</td><td>Position</td>

<td>Third incubation (4 minutes)</td><td> 50-63</td>

<td>Separation and washing</td><td> 64-67</td>

<td>Introduction and mixing of the fourth reagent</td><td> 71-72</td>

<td>Fourth incubation (4 minutes)</td><td> 73-86</td>

<td>Separation and washing</td><td> 87-90</td>

<td>Introduction and mixing of the pre-initiator</td><td> 94</td>

<td>Fifth incubation</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

Format E

Step Position

Sample introduction 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer a portion of the contents of the container 15 to the second container 15, the rest of the container 15 continued in the process track 28 24

The contents of the first container 15 continued to the first incubation (11 minutes) 24-63

Introduction and mixing of the second reagent with the content of the second container 15 2-3

The first vessel 15 passes through the bypass region 58B 64-67

First incubation (18 minutes) of the second container 15 4-63

Introducing the fourth reagent into the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total) 71-72

Separation and washing of the second container 64-67

Fourth incubation (4 minutes - optional) of the first vessel 15 73-86

Introduction of the third reagent in the second container 15 and mix 71-72

The first vessel 15 passes through the bypass region 58C 87-90

Third incubation (4 minutes) of the second container 15 73-86

Introducing the pre-initiator into the first container 15 and mixing 94

Separation and washing of the second container 15 87-90

Start and read the value 1 (total Hb) from the first container 15 98

Introducing the pre-initiator into the second container 15 and mixing 94

Start and read value 2 (GlyHb) 98

Referred result = value 2 / value 1 x 100

IS 2 174 154 T3

For example, in format E, it is possible to modify the format not taking into account the first container 15 after the portion of the contents of container 15 has been transferred (position 24) to the second container 15. In that case, format E can be used to determine, for example, folate and vitamin B12.

Format F

Step Position

Introduction of sample 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer portion of the contents of the container 15 to the second container 15, the rest of the container 15 continues in the process track 28 24

The contents of the first container 15 continue the first incubation (11 minutes) 24-63

Introduction and mixing of the second reagent with the content of the second container 15 2-3

The first container 15 passes through the bypass region 58B 64-67

First incubation (11 minutes) of the second container 15 4-40

Introduction of the fourth reagent into the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total) 71-72

Separation and washing of the second container 41-44

Fourth incubation (4 minutes - optional) of the first container 15 73-86

Introduction of the third reagent in the second container 15 and mix 48-49

The first vessel 15 passes through the bypass region 58C 87-90

Third incubation (11 minutes) of the second container 15 50-86

Introducing the pre-initiator into the first container 15 and mixing 94

Separation and washing of the second container 15 87-90

Start and read value 1 (total Hb) from the first vessel 15 98

Introducing the pre-initiator into the second container 15 and mixing 94

Start and read value 2 (GlyHb) 98

Referred result = value 2 / value 1 x 100

This format can be used, for example, to determine at least one of the total and glycated hemoglobin. Furthermore, this format can be modified not taking into account the first container 15 as in Format E.

IS 2 174 154 T3

Format G

Step Position

Sample introduction 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer portion of the contents of the container 15 to the second container 15, the rest of the container 15 continued in the process track 28 24

The contents of the first container 15 continued to the first incubation (11 minutes) 24-63

Introduction and mixing of the second reagent with the content of the second container 15 2-3

Separation and washing of the first container 15 64-67

First incubation (18 minutes) of the second container 15 4-63

Introducing the fourth reagent into the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total) 71-72

Separation and washing of the second container 64-67

Fourth incubation (4 minutes - optional) of the first container 15 73-86

Introduction of the third reagent in the second container 15 and mix 71-72

Separation and washing of the first container 15 87-90

Third incubation (4 minutes) of the second container 15 73-86

Introducing the pre-initiator into the first container 15 and mixing 94

Separation and washing of the second container 15 87-90

Start and read value 1 (total Hb) from the first vessel 15 98

Introducing the pre-initiator into the second container 15 and mixing 94

Start and read value 2 (GlyHb) 98

Referred result = value 2 / value 1 x 100

As an example, this format can also be modified as can be done with Format F. With this modification, this format can be used to determine progesterone, testosterone and estradiol. Format H

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation</td><td> 4-86</td>

<td>Separation and washing</td><td> 87-90</td>

<td>Introducing the pre-starter and mixing</td><td> 94</td>

<td>Second incubation</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

IS 2 174 154 T3

As an example, this format can be used to determine, among other things, beta human chorioan gonadotropin (B-hCG), prolactin, progesterone, testosterone, estradiol, and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. Format I

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid Introducing the first reagent into the first container 15, a portion of the contents of the first container 15 is passed to the pipettor, the rest of the container continues in the process track 28, bypassing all the</td><td> 1</td>

<td>washing stations, in position 71.Introduction of the first reagent into the</td><td> 2</td>

<td>15 second bowl and mix</td><td> 2-3</td>

<td>First incubation of the second container 15 First incubation (18 minutes) of the</td><td> 4-23</td>

<td>second container 15 Introduction of the second reagent in the first reagent 15 and mixing (optional, improves the chemiluminescent signal Hb</td><td> 24-63</td>

<td>total)</td><td> 71-72</td>

<td>Separation and washing of the second container Fourth incubation (4 minutes - optional)</td><td> 64-67</td>

<td>of the first container 15 Introduction of the third reagent in the</td><td> 73-86</td>

<td>15 second bowl and mix The first container 15 passes through the region</td><td> 71-72</td>

<td>bypass 58C Third incubation (4 minutes) of the second</td><td> 87-90</td>

<td>container 15 Introduction of the pre-initiator in the first</td><td> 73-86</td>

<td>container 15 and mix</td><td> 94</td>

<td>Separation and washing of the second container 15 Start and read value 1 (total Hb) of the</td><td> 87-90</td>

<td>first container 15 Introduction of the pre-initiator in the</td><td> 98</td>

<td>15 second bowl and mix</td><td> 94</td>

<td>Start and read value 2 (GlyHb)</td><td> 98</td>

Referred result = value 2 / value 1 X 100

As an example, in Format I, it is possible to modify the format not taking into account the first container 15 after the portion of the contents of container 15 (position 24) has been transferred to the second container 15. In that case, Format I can be used to determine, for example, folate and vitamin B12.

IS 2 174 154 T3

Format J

<td>He passed</td><td>Position</td>

<td>Introduction of the sample in the</td><td></td>

<td>container 15, possibly with fluid</td><td></td>

<td>thinner</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (27 minutes)</td><td> 4-93</td>

<td>Introduction of the pre-starter and mix</td><td> 94</td>

<td>Second incubation (1 minute)</td><td> 95-97</td>

<td>Home and reading</td><td> 98</td>

As an example, Format J can be used to determine, among other things, total hemoglobin.

The embodiments described here also allow sample pretreatment, which can be performed in at least two ways, indicated as K and L formats. During the sample pretreatment, the fluid present in the indicated containers can be processed, then they are not significant in the pretreatment steps, in any appropriate way, such as any of the formats discussed above. Furthermore, as will become clear later, both K and L formats are applicable in a substantially similar way to the other embodiments of the process path 10 explained below.

Format K

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-23</td>

<td>Transfer a portion of the contents of the first container 15 to the second container 15 at position 1</td><td> 24</td>

<td>Introducing the second reagent into the second container 15 and mixing (optional)</td><td> 2-3</td>

<td>Transfer a portion of the contents of the second container 15 to the third container 15 in position 1</td><td> 24</td>

<td>Introduction of the third reagent in the third container and mixing (optional)</td><td> 2-3</td>

As an example, the third container 15 can be processed according to at least one of the formats A (to determine, among other things, folate), B, C, H and J.

IS 2 174 154 T3

Format l

<td>He passed</td><td>Position</td>

<td colspan="2">Introduction of the sample in the first</td>

<td>container 15, possibly with diluent fluid</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-23</td>

<td>Transfer a portion of the contents of the first container 15 to the second container 15 in position 1</td><td> 24</td>

<td>Introducing the second reagent into the second container 15 and mixing (optional)</td><td> 2-3</td>

As an example, the second container 15 can be processed following at least one of the formats A (to determine, among other things, folate, vitamin B12, confirm HBsAb), B, C, H and J.

In each of the formats explained above, it is possible to move the contents of a first container 15 at position 2 to a second container 15 at position 1. Afterwards, the first container 15 may or may not be ignored.

It should be remembered, as noted above, that the steps of one format can be mixed with the steps of another format to arrive at additional formats. In addition, it must be remembered that the construction of the process path 10, and its supporting elements and components, allow a selective automatic realization (that is, a specific step may or may not be carried out, as desired) of the steps described above. .

These examples demonstrate the utility of the described embodiments in the controlled processing of determinations of items of interest in a sample within a common process path 10.

As explained above, multiple process paths 10 can be connected to meet specific needs. If the process path 10 performs approximately 200 determinations per hour, and if an analyzer (figure 29) is needed that performs 400 determinations per hour, two process paths 10 can be connected. One way of doing this is described with reference to the figures. 17, 29 and 30.

As illustrated in Figure 17, the process path 10 will be located in the space 140. To supply samples to the process path 10, a loading track 142 and a conveyor belt 146 connected to a frame 148 defining the space 140 are provided. In some embodiments, at least one of the loading track 142, the conveyor 146, and an unloading track 192 may be provided with a cover 194 (FIG. 30). A support 150 that supports multiple sample tubes 152, which may be suitable tubes, rides along the loading track 142 and conveyor 146. Loading track 142 and conveyor 146 move support 150 as indicated by the arrows. A transfer mechanism 154, such as a solenoid-driven arm (eg, linear drive) and the like, moves the support 150 from the loading track 142 to the conveyor 146.

Bracket 150 moves along conveyor belt 146 until bracket 150 is stopped by a retainer 156, that is, in the illustrated embodiment, a stepping motor that drives a star wheel that engages with the holder 150. Pipetting system 128 accesses the sample at position 130B and supplies the sample to container 15 in process path 10. Of course, suitable identification structures can be provided, such as bar codes on sample tubes 152 and a bar code reader. When the pipetting system 128, or any of the pipetting systems 128, 132 or 134 accesses a fluid, the pressure of the pipetting system can be verified as described in WO-A-97/22007 jointly (Patent Application U.S. Serial Number 08 / 572,835 filed December 14, 1995. Appropriate liquid level sensing devices, such as radio frequency and analog based devices, may also be located in suitable positions.

In an exemplary embodiment, the loading track 142 may be the n^° 77325-101 and conveyor belt 146 can be the n^° 77425-101, available from Dorner Manufacturing of Hartland, Wisconsin.

IS 2 174 154 T3

Runway 192 may be # 77525-101 available from SPM / Portland of Hillsboro, Oregon. Retainer 156 may be # 77476-101 available from Pacific Scientific of Elgin, Illinois. Transfer mechanism 154 may include a solenoid such as No.^° 77952 available from Lucas / Ledex of Vandalia, Ohio, a strap such as No.^° 6R25-M225090 and a pulley such as No.^° A 6725-020DF0908, available from Stock Drive Parts of New Hyde Park, New York, and a stepper motor such as n^° p21NSXS-LSS-NS07 available from Pacific Scientific of Elgin, Illinois.

In some cases, a sample level in a sample tube 152 may be insufficient for access by pipetting system 128. In these cases, the sample within sample tube 152 may be moved by an operator to another container 208 shown in Figures 31A, 31B and 31C. Container 208 includes a stem 210 and a flange 212. The stem 210 is dimensioned to fit within the sample tube 152 as shown in FIG. 31C. Flange 212 is offset from an outer diameter surface of barrel 210 a distance sufficient to accommodate suitable sample tubes 152. In this way, sample can be passed from sample tube 152 to container 208 and container 208 can be placed within of sample tube 152. Sample tube 152 that supports container 208 can then be placed in bracket 150. Since the sample is now in container 208, the level of the sample is elevated relative to the level of the sample in sample tube 152, thereby facilitating access to the sample by pipetting system 128.

In an exemplary embodiment, the container 208 can be made of DOW 666 polystyrene and is sized to fit within sample tubes that have outside diameters substantially within the range of about 10.16 mm (0.4 inch) to about 17.78 mm. mm (0.7 inch). The Canon 210 has an outer diameter that measures approximately 10.16 mm (0.4 inch) and a length of approximately 4.98856 cm (1.964 inches). Flange 212 has an outer diameter measuring approximately 1.97104 mm (0.776 inch), hangs from an open end of container 208 a distance of approximately 5.4864 mm (0.216 inch), and is offset from the outer diameter surface of the barrel. 210 a distance of approximately 6.5532 mm (0.258 inch).

In some embodiments, the loading track 142 is removed and replaced by a sample supply conveyor having a similar retainer 156. If this is done, the pipetting system 128 will access the sample at position 130A. In this case, in further embodiments, a carousel 189 may be operatively connected to frame 148 by a connecting element 193 as shown in Figures 26 and 27. Connecting element 193 positions carousel 189 with respect to process path 10 such that pipetting system 128 can also access containers on carousel 189 at position 130B. Carousel 189 can be used, for example, to house determination calibrators and controls and some samples, such as emergency samples that need to be processed immediately. In an exemplary embodiment, carousel 189 may be a 2 to 3 piece injection molded polymeric article (ABS, GE-Cycolac or analogs) constructed substantially similar to a DTx® unit dose carousel, an IMx Select® carousel (Abbott Laboratories , Abbott Park, Illinois) and analogous.

In some cases, retainer 156 may not retain holder 150 for access to the sample, but may allow holder 150 to move toward one end 158 of conveyor 146 toward another process path 10. In this case, frame 148 includes a connecting structure 160 for operatively coupling one process path 10 to another, or more specifically, a frame 148 that supports one process path 10 to another frame 148 that supports another process path 10. In an exemplary embodiment, connecting structure 160 can be constructed such that two adjacent frames 148 are offset by a distance substantially within the range of about 6.35 mm (0.25 in.) To about 3.81 cm (1. 5 inches).

The connecting structure 160 includes a first support 162 and a second support 164. The first support 162 is connected to a frame 148 and the second support 164 is connected to the other frame 148. To connect the frames 148, a fastener is placed, such as a bolt and the like, between aligned holes 166 in the first and second brackets 162 and 164. Another fastener is inserted into slots 168 provided at opposite ends of the brackets 162 and 164. The conveyor belts 146 supported by both frames 148 have sufficient tolerance such that a more exact alignment of the frames 148 is not required. When a support 150 exits one end 158 of a conveyor 146, the support 150 is supported by a opposite end 196 of an adjacent conveyor 146. Once the support 150 reaches the end 158 of the last conveyor 146, the support 150 is moved to an unloading track 192 (FIG. 29), constructed of and operating substantially the same as the loading track 142, by another mechanism of transfer 197, which may be substantially

ES 2 174 154 T3 similar to transfer mechanism 154.

The construction of the process path 10 can also be adapted in other ways to meet other requirements. For example, it may be desirable to provide a process run 10 that performs 100, 50, or any desired number of determinations per hour. Viewing this requirement in another way, it may be desirable to provide a process path 10 that fits within a certain physical space, such as a tabletop. To meet these requirements, the process path 10 can be scaled, that is, altered in size or determinations per hour while still including elements explained above, such as a bypass region, a mixing device, a pipetting system, a station of wash and a reader.

Another embodiment is a process path 10-, constructed to perform 100 determinations per hour, and is illustrated in Figures 20A and 20B. This embodiment uses elements substantially similar to those described above, therefore analogous reference characters are used. The same indexing period and assay formats are used, thereby allowing the same reagents to be used. Due to the reduced number of determinations per hour, it is possible to correspondingly reduce the physical dimensions of the embodiment. For example, while the process path 10 of the preceding figures includes 112 positions, the process path 10- includes approximately 55 positions. In another embodiment, which performs 50 determinations per hour, the corresponding process path includes approximately 32 positions.

While the determinations made with the process path 10 are completed without a container 15 passing more than once through the same position along the process path 28, the containers 15 used with the process path 10 - can pass more than once for the same position along process track 28. Depending on the specific needs to be addressed, the process path can be modified such that a container 15 passes through the same position along the process path any appropriate number of times. Naturally, depending on the particular use, a given container 15 may be placed on a different track of a performance track 62 and an avoidance track 64 of a given lead region 58 at different times passing through the same lead region 58 during a run. determination given.

Illustrating it better with an example, the following describes the procedures performed at each position along the process path 10- which performs 100 determinations in one hour. As noted above, a particular container 15 can pass more than once through a given position along the process path 10-. Therefore, the process position 1 indicates the first time that the container 15 finds the process position 1, while the process position 1 'indicates the second time that the container 15 finds the process position 1. In addition, of Similarly, process position 1 "indicates the third time that container 15 encounters process position 1. Furthermore, process path 10- is constructed in such a way that once a container 15 reaches process position 46 a first time, the next process position container 15 arrives may be process position 1. ', that is, the container 15 moves from one end of the process path 10- to an opposite end of the process path 10-.

In the illustrated embodiment of the process path 10-, a second processing track 170 is included. The second processing track 170 may be located at any suitable position relative to the processing track 28 so that a container 15 can be moved. between process track 28 and process track 170. In some embodiments, the position of the process track 170 can be chosen to keep the process path 10- within specified physical dimensions.

A prime mover, which may be substantially similar to the prime movers discussed above, is located, in an exemplary embodiment, at an adjacent position 46 along process track 28. This prime mover can operate to move a vessel 15 from process track 28 to process track 170 when desired, namely, to read a determination reaction, removal of a container 15 from process path 10-, etc. Process track 28 may be linked to process track 170 by suitable connecting structures 172, such as those associated with a bypass region. In this way, a container 15 can be selectively and automatically moved between process track 28 and process track 170. Thus, upon reaching process position 46, a container 15 can be moved to process position 1 of process track 28, or, alternatively, it can be moved from process position 46 of process track 28 to Process positions 47 to 55 of process track 170. Once in process track 170, the process steps detailed in the following example are performed. Naturally, structures, similar to those explained above, that carry out the

ES 2 174 154 T3 process steps, are arranged along process track 170 which has sufficient dimensions to accommodate said structures.

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 1</td><td>Container loading fifteen</td><td>Container 15 passes from loading track 30, if present, to process track 28 as required</td>

<td> 1</td><td>Sample pipettor</td><td>The sample is deposited into container 15 by pipetting system 128. The sample can be obtained from position 130A or 130B that are located on appropriate conveyors</td>

<td> 2</td><td>Reagent pipettor 1</td><td>The reagent obtained from the reagent carousel 131 is deposited into the container 15 by the pipetting system 132</td>

<td> 3</td><td>Mixer</td><td>The contents of the container 15 are mixed by a device 86 that imparts movement to the container 15</td>

<td> 4-16</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature, approximately 37 degrees Celsius</td>

<td> 17</td><td>Beginning of the region of derivation</td><td>Container 15 is selectively positioned at the entrance to the embodiment track 62 or bypass track 64 of the bypass region.</td>

<td> 18</td><td>Washing zone 1</td><td>Container 15 on runway 62 undergoes magnetic separation and fluid addition</td>

<td> 19</td><td>Washing zone 1</td><td>Container 15 on runway 62 undergoes magnetic separation, aspiration of the contents of container 15, and addition of fluid.</td>

<td> 20</td><td>Washing zone 1</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 21</td><td>Washing zone 1</td><td>Container 15 on runway 62 undergoes magnetic separation, and aspiration of the contents of container 15</td>

<td> 22</td><td>End of bypass region</td><td>Realization and avoidance tracks 62 and 64 of the bypass region join</td>

<td> 23-24</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 24</td><td>Sample pipettor</td><td>The sample can be drawn from container 15 by pipetting system 128 for deposition into a second container 15 at position 1</td>

<td> 25</td><td>Reagent pipettor 2</td><td>The reagent obtained from the reagent carousel 131 can be deposited into the container by the pipetting system 132</td>

<td> 26</td><td>Mixer</td><td>The contents of the container 15 are mixed by a device 86 that imparts movement to the container 15</td>

<td> 27-39</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 40</td><td>Start of the bypass region</td><td>Container 15 is selectively positioned at the entrance to embodiment track 62 or bypass track 64 of the bypass region</td>

<td> 41</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation and fluid addition</td>

<td> 42</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 43</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 44</td><td>Washing zone 2</td><td>Vessel 15 on runway 62 undergoes magnetic separation and aspiration of the contents of vessel 15</td>

<td> 45.5</td><td>End of bypass region</td><td>Execution track 62 and bypass region avoidance track 64 are joined (midway between positions 45 and 46)</td>

<td> 46</td><td>Process track transfer</td><td>The container moves from the transfer position 46 'of the process track 28 to the process position 46 of the process track 170</td>

<td> 46-47</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 48</td><td>Pre-starter and mixer</td><td>Reagent is added to the container 15 and mechanically mixed</td>

<td> 49-51</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 52</td><td>Shutter, Reader, and Launcher</td><td>The indicator reaction (such as the chemiluminescent reaction) is initiated and read with magnetic particles pulled out of solution with a magnet. The shutter blocks ambient light.</td>

<td> 54</td><td>Aspirating liquid residue</td><td>Magnetic particles are held on a wall of container 15 and all liquid in container 15 is sucked up and discarded</td>

<td> 55</td><td>Vessel discharge fifteen</td><td>Container 15 is removed from process track 28</td>

Given these modifications, it is possible to use determination formats that are substantially similar to those explained above. For the sake of clarity, the formats, performed by process walk 10-, are listed below.

IS 2 174 154 T3

Format A

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (18 minutes)</td><td> 4-17</td>

<td>Vessel 15 passes through the region of</td><td></td>

<td>Bypass, the first incubation continues</td><td> 18-21</td>

<td>The first incubation continues</td><td> 22-40</td>

<td>Container 15 passes through the region of</td><td></td>

<td>Bypass, the first incubation continues</td><td> 41-44</td>

<td>The first incubation continues</td><td> 45-17'</td>

<td>Separation and washing</td><td> 18'-21'</td>

<td>Introduction and mixing of the second reagent</td><td> 25'-26'</td>

<td>Second incubation (4 minutes)</td><td> 27'-40'</td>

<td>Separation and washing</td><td> 41'-44'</td>

<td>Container 15 is transferred from the</td><td>46 'from 28 to</td>

<td>process track 28 to process track 170</td><td>46 of 170</td>

<td>Introduction and mixing of pre-initiator</td><td> 48</td>

<td>Third incubation (1 minute)</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

<td>Evacuate the container 15</td><td> 54</td>

<td>Container Removal 15</td><td> 55</td>

For example, format A can be used to determine at least the following items of interest: Antibodies to HCV, Antibodies to HIV 1 / HIV 2, Antibodies to Hepatitis B Nuclear Antigen (HBcAb), Carcinoembryonic Antigen (CEA), Cancer Antigen 19-9 (CA19-9), Hepatitis B Surface Antigen (HBsAb) , antibodies to hepatitis B surface antigen (HBsAb), alpha-fetoproteon (AFP), total prostate-specific antigen (total PSA), free PSA, thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone ( FSH), Human chorionic gonadotropin beta (B-hCG), free thyroxine (free T4), free triiodothyronine (free T3), total T4, total T3, prolactin and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. For example, this format can also be used to determine beta human chorionic gonadotropin (B-hCG), prolactin, and ferritin.

Format B

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-40</td>

<td>Separation and washing</td><td> 41-44</td>

<td>Introduction and mixing of the second reagent</td><td> 2'-3'</td>

<td>Second incubation (11 minutes)</td><td> 4'-40'</td>

<td>Separation and washing</td><td> 41'-44'</td>

<td>Container 15 is transferred from the</td><td>46 'from 28 to</td>

<td>process track 28 to process track 170</td><td>46 of 170</td>

<td>Introduction and mixing of the pre-starter</td><td> 48</td>

<td>Third incubation (1 minute)</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

<td>Container evacuation 15</td><td> 54</td>

<td>Container Removal 15</td><td> 55</td>

As an example, format B can be used to determine an item of interest in a sample.

ES 2 174 154 T3 where a relatively higher degree of sensitivity is desired, compared to other formats. It should be noted that almost any item of interest explained here can be determined using this format correctly.

Format C

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-40</td>

<td>Separation and washing</td><td> 41-44</td>

<td>Introduction and mixing of a second reagent</td><td> 2'-3'</td>

<td>Second incubation (4 minutes)</td><td> 4'-17'</td>

<td>Separation and washing</td><td> 18'-21'</td>

<td>Introduction and mixing of the third reagent</td><td> 25'-26'</td>

<td>Third incubation (4 minutes)</td><td> 27'-40'</td>

<td>Separation and washing</td><td> 41'-44'</td>

<td>Container 15 is transferred from the</td><td>46 'from 28 to</td>

<td>process track 28 to process track 170</td><td>46 of 170</td>

<td>Introduction and mixing of the pre-initiator</td><td> 48</td>

<td>Fourth incubation (1 minute)</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

<td>Container evacuation 15</td><td> 54</td>

<td>Container Removal 15</td><td> 55</td>

As an example, format C can be used when the item of interest refers to hepatitis, such as determinations for anti-M, HBcAb-M and HAVAb-M.

Format D

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction of the first reagent mixture</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-17</td>

<td>Transfer to second container 15 in</td><td></td>

<td>position 1</td><td> 25</td>

<td>Introduction and mixing of a second reagent</td><td> 2-3</td>

<td>Second incubation (11 minutes)</td><td> 4-40</td>

<td>Separation and washing</td><td> 41-44</td>

<td>Introduction and mixing of the third reagent</td><td> 2'-3'</td>

<td>Third incubation (4 minutes)</td><td> 4'-17'</td>

<td>Separation and washing</td><td> 18'-21'</td>

<td>Introduction and mixing of the fourth reagent</td><td> 25'-26'</td>

<td>Fourth incubation (4 minutes)</td><td> 27'-40'</td>

<td>Separation and washing</td><td> 41'-44'</td>

<td>The container is transferred from the track</td><td>46 'from 28 to</td>

<td>from process 28 to process track 170</td><td>46 of 170</td>

<td>Introducing and mixing the pre-initiator</td><td> 48</td>

<td>Fifth incubation (1 minute)</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

<td>Container evacuation 15</td><td> 54</td>

<td>Container Removal 15</td><td> 55</td>

IS 2 174 154 T3

Format E

<td></td><td>He passed</td><td>Position</td>

<td> 5</td><td>Sample introduction</td><td> 1</td>

<td></td><td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td></td><td>First incubation (7 minutes)</td><td> 4-24</td>

<td></td><td>Transfer a portion of the content of the</td><td> 25</td>

<td> 10</td><td>vessel 15 to second vessel 15, remainder of vessel 15 continues on process track 28 The contents of the first container 15</td><td> 25-17'</td>

<td rowspan="2"> 15 20</td><td>the first incubation continues (11 minutes) Introduction and mixing of the second reagent with the content of the second container 15 The first container 15 passes through the region</td><td> 2-3</td>

<td>bypass 58B</td><td> 18'-21'</td>

<td></td><td>First incubation (18 minutes) of the second container 15 Introduction of the fourth reagent in the</td><td> 4-17</td>

<td> 25</td><td>first vessel 15 and mixing (optional, improves chemiluminescent signal total Hb)</td><td> 25'-26'</td>

<td></td><td>Separation and washing of the second container Fourth incubation (4 minutes - optional)</td><td> 18'-21'</td>

<td> 30</td><td>of the first container 15 Introduction of the third reagent in the</td><td> 27'-40'</td>

<td></td><td>15 second bowl and mix The first container 15 passes through the region</td><td> 25'-26'</td>

<td rowspan="2"> 35</td><td>bypass</td><td> 41'-44'</td>

<td rowspan="2">Third incubation (4 minutes) of the second container 15</td><td rowspan="2"> 27'-40'</td>

<td></td>

<td></td><td>The first container 15 is transferred from</td><td>46 'from 28 to</td>

<td></td><td>process track 28 to track</td><td>46 of 170</td>

<td> 40</td><td>process 170 Introducing the pre-initiator into the first container 15 and mixing Separation and washing of the second container</td><td> 48</td>

<td rowspan="2"> 45</td><td> 15</td><td> 41'-44'</td>

<td>The second container 15 is transferred from</td><td>46 'from 28 to</td>

<td></td><td>process track 28 to process track 170 Start and read value 1 (total Hb) from</td><td>46 of 170</td>

<td> 50</td><td>first container 15 Introduction of the pre-initiator in the</td><td> 52</td>

<td></td><td>15 second bowl and mix</td><td> 48</td>

<td rowspan="2">55 Referred result =</td><td>Start and read value 2 (GlyHb)</td><td> 52</td>

<td>value 2 / value 1 X 100</td><td></td>

For example, in Format E, it is possible to modify the format not taking into account the first container 15 after having transferred the portion of the contents of container 15 (position 24) to the second ⁶⁰ container 15. In that case, format E can be used to determine, for example, folate and vitamin B12.

IS 2 174 154 T3

Format F

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-24</td>

<td>Transfer a portion of the contents of the container 15 to the second container 15, the rest of the container 15 continues in the process track 28</td><td> 25</td>

<td>The contents of the first container 15 continue the first incubation (11 minutes)</td><td> 25-17'</td>

<td>Introduction and mixing of the second reagent with the content of the second container 15</td><td> 2-3</td>

<td>The first container 15 passes through the bypass region 58B</td><td> 18'-21'</td>

<td>First incubation (11 minutes) of the second vessel 15</td><td> 4-40</td>

<td>Introduction of the fourth reagent in the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 25'-26'</td>

<td>Separation and washing of the second container</td><td> 41-44</td>

<td>Fourth incubation (4 minutes - optional) of the first vessel 15</td><td> 27'-40'</td>

<td>Introducing the third reagent into the second container 15 and mixing</td><td> 2'-3'</td>

<td>The first container 15 passes through the bypass region</td><td> 41'-44'</td>

<td>Third incubation (11 minutes) of the second vessel 15</td><td> 4'-40'</td>

<td>The first container 15 is transferred from</td><td>46 'from 28 to</td>

<td>process track 28 to track</td><td>46 of 170</td>

<td>process 170 Introducing the pre-initiator into the first container 15 and mixing</td><td> 48</td>

<td>Separation and washing of the second container fifteen</td><td> 41'-44'</td>

<td>Start and read value 1 (total Hb) from the first vessel 15</td><td> 52</td>

<td>The second container 15 is transferred from</td><td>46 'from 28 to</td>

<td>process track 28 to track</td><td>46 of 170</td>

<td>process 170 Introducing the pre-initiator into the second container 15 and mixing</td><td> 48</td>

<td>Start and read value 2 (GlyHb)</td><td> 52</td>

Referred result = value 2 / value 1 X 100

This format can be used, for example, to determine at least one of the total and glycated hemoglobin. Furthermore, this format can be modified not taking into account the first container 15 as in Format E.

IS 2 174 154 T3

Format G

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-24</td>

<td>Transfer a portion of the contents of the container 15 to the second container 15, the rest of the container 15 continues in the process track 28</td><td> 25</td>

<td>The contents of the first container 15 continue the first incubation (11 minutes)</td><td> 25-17'</td>

<td>Introduction and mixing of the second reagent with the content of the second container 15</td><td> 2-3</td>

<td>Separation and washing of the first container fifteen</td><td> 18'-21'</td>

<td>First incubation (18 minutes) of the second container</td><td> 4-17'</td>

<td>Introduction of the fourth reagent in the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 25'-26'</td>

<td>Separating and washing the second container</td><td> 18'-21'</td>

<td>Fourth incubation (4 minutes - optional) of the first vessel 15</td><td> 27'-40'</td>

<td>Introducing the third reagent into the second container 15 and mixing</td><td> 25'-26'</td>

<td>Separation and washing of the first container fifteen</td><td> 41'-44'</td>

<td>Third incubation (4 minutes) of the second container 15</td><td> 27'-40'</td>

<td>The first container 15 is transferred from</td><td>46 'from 28 to</td>

<td>process track 28 to track</td><td>46 of 170</td>

<td>process 170 Introducing the pre-initiator into the first container 15 and mixing</td><td> 48</td>

<td>Separating and washing the second container fifteen</td><td> 41'-44'</td>

<td>The second container 15 is transferred from</td><td>46 'from 28 to</td>

<td>process track 28 to track</td><td>46 of 170</td>

<td>process 170 Start and read value 1 (total Hb) from the first vessel 15</td><td> 52</td>

<td>Introducing the pre-initiator into the second container 15 and mixing</td><td> 48</td>

<td>Start and read value 2 (GlyHb)</td><td> 52</td>

Referred result = value 2 / value 1 X 100

For example, this format can also be modified as can be done with Format F. With this modification, this format can be used to determine progesterone, testosterone and estradiol.

IS 2 174 154 T3

Format H

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation</td><td> 4-41'</td>

<td>Separation and washing</td><td> 42'-44'</td>

<td>Transfer of container 15 from</td><td>46 'from 28 to</td>

<td>process track 28 to process track</td><td>46 'of 170</td>

<td> 170</td><td></td>

<td>Introducing the pre-starter and mixing</td><td> 48</td>

<td>Second incubation</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

For example, this format can be used to determine, among other things, beta human chorioan gonadotropin (B-hCG), prolactin, progesterone, testosterone, estradiol, and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. Format I

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid</td><td> 1</td>

<td>Introducing the first reagent into the first container 15, a portion of the content of the first container 15 is moved to the pipettor, the rest of the container continues in the process track 28, bypassing all the washing stations, to position 25 '</td><td> 2</td>

<td>Introducing the first reagent into the second container 15 and mixing</td><td> 2-3</td>

<td>First incubation (18 minutes) of the second container</td><td> 4-17'</td>

<td>Introducing the second reagent into the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 25'-26'</td>

<td>Separation and washing of the second container</td><td> 18'-21'</td>

<td>Fourth incubation (4 minutes - optional) of the first vessel 15</td><td> 27'-40'</td>

<td>Introduction of the third reagent into the second container 15 and mix</td><td> 25'-26'</td>

<td>The first container 15 passes through the bypass region 58</td><td> 41'-44'</td>

ES 2 174 154 T3 (Continued)

<td>He passed</td><td>Position</td>

<td>Third incubation (4 minutes) of the second</td><td></td>

<td>container 15</td><td> 27’-40’</td>

<td>Introduction of the pre-initiator in the first</td><td></td>

<td>container 15 and mix</td><td> 48</td>

<td>Separation and washing of the second container</td><td></td>

<td> 15</td><td> 41'-44'</td>

<td>Start and read value 1 (total Hb) from</td><td></td>

<td>first container 15</td><td> 52</td>

<td>Introduction of the pre-initiator in the</td><td></td>

<td>15 second bowl and mix</td><td> 48</td>

<td>Start and read value 2 (GlyHb)</td><td> 52</td>

Referred result = value 2 / value 1 X 100

For example, in Format I, it is possible to modify the format not taking into account the first container 15 after having transferred the portion of the contents of container 15 (position 24) to the second container 15. In that case, format I can be use to determine, for example, folate and vitamin B12.

Format J

<td>He passed</td><td>Position</td>

<td>Introduction of the sample in the</td><td></td>

<td>container 15, possibly with fluid</td><td></td>

<td>thinner</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (27 minutes - twice</td><td></td>

<td>along process track 28)</td><td> 4-47</td>

<td>Introduction of the pre-starter and mix</td><td> 48</td>

<td>Second incubation (1 minute)</td><td> 49-51</td>

<td>Home and reading</td><td> 52</td>

For example, the J format can be used to determine, among other things, total hemoglobin.

The embodiments described herein also allow sample pretreatment that can be performed in at least two ways, indicated as K and L formats. During the performance of sample pretreatment, the fluid present in the indicated containers 15 can be processed, after which they are no longer significant in pretreatment steps, in any appropriate way, such as any of the formats discussed above. Furthermore, as will become clear later, both K and L formats are applicable in a substantially similar way to the other embodiment of the process path 10 explained below.

IS 2 174 154 T3

Format K

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-23</td>

<td>Transfer a portion of the contents of the first container 15 to the second container 15 in position 1</td><td> 24</td>

<td>Introducing the second reagent into the second container 15 and mixing (optional)</td><td> 2-3</td>

<td>Transfer a portion of the contents of the second container 15 to the third container 15 in position 1</td><td> 24</td>

<td>Inserting the third reagent into the third container and mixing (optional)</td><td> 2-3</td>

For example, the third container 15 can be processed according to at least one of the formats A (to determine, among other things, folate), B, C, H and J.

Format L

Step Position

Introducing the sample into the first container 15, possibly with diluting fluid 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer a portion of the contents of the first container 15 to the second container 15 at position 1 24

Introducing the second reagent into the second container 15 and mixing (optional) 2-3

For example, the second container 15 can be processed according to at least one of the formats A (to determine, among other things, folate, vitamin B12, confirm HBsAb), B, C, H and J.

Another embodiment is a process path 10 *, substantially similar to the previous embodiment, of the process path 10 constructed to perform 50 determinations per hour. Elements similar to those described above are used, along with the same indexing period and assay formats, thereby allowing the same reagents to be used although in an embodiment that has relatively smaller physical dimensions. After the examples explained above, the following examples refer to this process path 10^* . In these examples, it is assumed that only one pipettor is used. Furthermore, while the previous examples performed determinations while moving a container 15 twice along process track 28, process path 10^* performs determinations while moving a container 15 along process track 28 four times. Thus, the second time that process position 1 is found is indicated as 1 ', the third time as 1 ”and the fourth time You see like ”'. However, it should be noted that more or fewer motions may be employed along the process track 28. Furthermore, process track 28 of this embodiment includes 23 process positions, with process position 23 being located next to process position 1.

IS 2 174 154 T3

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 1</td><td>Container loading fifteen</td><td>Container 15 passes from loading track 30, if present, to process track 28 as required</td>

<td> 1</td><td>Pipettor</td><td>The sample is deposited in the container 15 by the pipetting system</td>

<td> 2</td><td>Pipettor</td><td>The reagent obtained from the reagent carousel 131 is deposited in the container 15</td>

<td> 3</td><td>Mixer</td><td>The contents of the container 15 are mixed by a device 86 that imparts movement to the container 15</td>

<td> 4-16</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature, approximately 37 degrees Celsius</td>

<td> 17</td><td>Start of the region of derivation</td><td>Container 15 is selectively positioned at the entrance to realization track 62 or bypass region avoidance track 64</td>

<td> 18</td><td>Washing zone 1</td><td>Vessel 15 on runway 62 experiences magnetic separation and fluid addition</td>

<td> 19</td><td>Washing zone 1</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and addition of fluid.</td>

<td> 20</td><td>Washing zone 1</td><td>Vessel 15 on runway 62 undergoes magnetic separation, aspiration of the contents of vessel 15, and fluid addition</td>

<td> 21</td><td>Washing zone 1</td><td>Container 15 on runway 62 undergoes magnetic separation, and aspiration of the contents of container 15</td>

<td> 22</td><td>End of bypass region</td><td>Realization and avoidance tracks 62 and 64 of the bypass region join</td>

<td> 23</td><td>Process track transfer</td><td>Container 15 is selectively transferred from process track 28 to process track 170</td>

<td> 24</td><td>Pre-starter and mixer</td><td>Reagent is added to the container 15 and mechanically mixed</td>

ES 2 174 154 T3 (Continued)

<td>Process position</td><td>Step of process</td><td>Description</td>

<td> 26-28</td><td>Incubation</td><td>The contents of container 15 are incubated at a controlled temperature</td>

<td> 29</td><td>Shutter, Reader, and Launcher</td><td>The indicator reaction (such as the chemiluminescent reaction) is started and read with magnetic particles pulled out of the solution with a magnet. The shutter blocks ambient light.</td>

<td> 31</td><td>Aspirating liquid waste</td><td>The magnetic particles are retained on a wall of the container 15 and all the liquid in the container 15 is sucked up and disposed of.</td>

<td> 32</td><td>Container discharge 15</td><td>Container 15 is removed from process track 28</td>

Given these modifications, it is possible to use determination formats that are substantially similar to those explained above. For reasons of clarity, the formats are listed below, such as that performed by a process tour that performs 50 determinations per hour.

Format A

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (18 minutes)</td><td> 4-17</td>

<td>Vessel 15 passes through the region of</td><td></td>

<td>referral, the first incubation continues</td><td> 18-21</td>

<td>The first incubation continues</td><td> 22-17”</td>

<td>Separation and washing</td><td> 18”-21”</td>

<td>Introduction of a second reagent and mixing</td><td> 2” '-3”'</td>

<td>Second incubation (4 minutes)</td><td> 4”'_-17”'</td>

<td>Separation and washing</td><td> 18”'-21”'</td>

<td>Container 15 is transferred from the</td><td>23 ”'from 28 to</td>

<td>process track 28 to process track</td><td>23 of 170</td>

<td> 170</td><td></td>

<td>Introducing the pre-starter and mixing</td><td> 25</td>

<td>Third incubation (1 minute)</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

<td>Container evacuation 15</td><td> 31</td>

<td>Container Removal 15</td><td> 32</td>

For example, format A can be used to determine at least the following items of interest: Antibodies to HCV, Antibodies to HIV 1 / HIV 2, Antibodies to Hepatitis B Nuclear Antigen (HBcAb), Carcinoembryonic Antigen (CEA), Cancer Antigen 19-9 (CA19-9), Hepatitis B Surface Antigen (HBsAb) , antibodies to hepatitis B surface antigen (HBsAb), alpha-fetoprotein (AFP), total prostate specific antigen (total PSA), free PSA, thyroid stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone ( FSH), gonadotropin

ES 2 174 154 beta human chorionic T3 (B-hCG), free thyroxine (free T4), free triiodothyronine (free T3), total T4, total T3, prolactin and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. For example, this format can also be used to determine beta human chorionic gonadotropin (B-hCG), prolactin, and ferritin.

Format B

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-17'</td>

<td>Separation and washing</td><td> 18'-21'</td>

<td>One second introduction and mixing</td><td></td>

<td>reagent</td><td> 2”-3”</td>

<td>Second incubation (11 minutes)</td><td> 4”-17”'</td>

<td>Separation and washing</td><td> 18”'-21”'</td>

<td>Vessel 15 is transferred from the</td><td>23 ”'from 28 to</td>

<td>process track 28 to process track</td><td>23 of 170</td>

<td> 170</td><td></td>

<td>Introduction of the pre-starter and mix</td><td> 25</td>

<td>Third incubation (1 minute)</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

<td>Container evacuation 15</td><td> 31</td>

<td>Container Removal 15</td><td> 32</td>

For example, format B can be used to determine an item of interest in a sample where a relatively higher degree of sensitivity is desired, compared to other formats. It should be noted that almost any item of interest explained here can be determined using this format correctly.

Format C

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (11 minutes)</td><td> 4-17'</td>

<td>Separation and washing</td><td> 18'-21'</td>

<td>Introduction of a second reagent and</td><td></td>

<td>mix</td><td> 2”-3”</td>

<td>Second incubation (4 minutes)</td><td> 4”-17”</td>

<td>Separation and washing</td><td> 18”-21”</td>

<td>Introduction of the third reagent and mixing</td><td> 2” '-3”'</td>

<td>Third incubation (4 minutes)</td><td> 4”'_-17”'</td>

<td>Separation and washing</td><td> 18”'-21”'</td>

<td>Vessel 15 is transferred from the</td><td>23 ”'from 28 to</td>

<td>process track 28 to process track</td><td>23 of 170</td>

<td> 170</td><td></td>

<td>Introducing the pre-starter and mixing</td><td> 25</td>

<td>Fourth incubation (1 minute)</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

<td>Container evacuation 15</td><td> 31</td>

<td>Container Removal 15</td><td> 32</td>

IS 2 174 154 T3

For example, format C can be used when the item of interest refers to hepatitis, such as determinations for anti-M, HBcAb-M and HAVAb-M.

Format D

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-17</td>

<td>Transfer to second container 15 in</td><td></td>

<td>position 1</td><td> 23</td>

<td>One second introduction and mixing</td><td></td>

<td>reagent</td><td> 2-3</td>

<td>Second incubation (11 minutes)</td><td> 4-17'</td>

<td>Separation and washing</td><td> 18’-21’</td>

<td>Introduction of the third reagent and mixing</td><td> 2”-3”</td>

<td>Third incubation (4 minutes)</td><td> 4”-17”</td>

<td>Separation and washing</td><td> 18”-21”</td>

<td>Introduction of the reagent room and mixing</td><td> 2” '-3”'</td>

<td>Fourth incubation (4 minutes)</td><td> 4”'_-17”'</td>

<td>Separation and washing</td><td> 18”'-21”'</td>

<td>The container is transferred from the</td><td>23 ”'from 28 to</td>

<td>process track 28 to process track</td><td>23 of 170</td>

<td> 170</td><td></td>

<td>Introduction of the pre-starter and mix</td><td> 25</td>

<td>Fifth incubation (1 minute)</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

<td>Container evacuation 15</td><td> 31</td>

<td>Container Removal 15</td><td> 32</td>

Format E

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-17</td>

<td>Transfer a portion of the contents of the container 15 to the second container 15, the rest of the container 15 continued in the process track 28</td><td> 23</td>

<td>The contents of the first container 15 continued to the first incubation (11 minutes)</td><td> 23-17'</td>

<td>Introducing the second reagent and mixing with the content of the second container 15</td><td> 2-3</td>

<td>The first vessel 15 passes through the bypass region 58B</td><td> 18”-21”</td>

ES 2 174 154 T3 (Continued)

<td>He passed</td><td>Position</td>

<td>First incubation (18 minutes) of the second container 15</td><td> 4-17”</td>

<td>Introduction of the fourth reagent in the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 2”'-3”'</td>

<td>Separation and washing of the second container</td><td> 18'-21'</td>

<td>fourth incubation (4 minutes - optional) of the first container 15</td><td> 4”'_-17”'</td>

<td>Introducing the third reagent into the second container 15 and mixing</td><td> 25'-26'</td>

<td>The first container 15 passes through the bypass region</td><td> 18”'-21”'</td>

<td>Third incubation (4 minutes) of the second container 15</td><td> 4”'_-17”'</td>

<td>The first container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td>process track 28 to track</td><td>23 of 170</td>

<td>process 170 Introducing the pre-initiator into the first container 15 and mixing</td><td> 25</td>

<td>Separation and washing of the second container fifteen</td><td> 18”'-21”'</td>

<td>The second container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td>process track 28 to track</td><td>23 of 170</td>

<td>process 170 Start and read value 1 (total Hb) from the first vessel 15</td><td> 29</td>

<td>Introducing the pre-initiator into the second container 15 and mixing</td><td> 25</td>

<td>Start and read value 2 (GlyHb)</td><td> 29</td>

Referred result = value 2 / value 1 X 100

For example, in Format E, it is possible to modify the format not taking into account the first container 15 after having transferred the portion of the contents of container 15 (position 24) to the second container 15. In that case, format E can be use to determine, for example, folate and vitamin B12.

IS 2 174 154 T3

Format F

<td></td><td>He passed</td><td>Position</td>

<td> 5</td><td>Sample introduction</td><td> 1</td>

<td></td><td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td></td><td>First incubation (7 minutes) Transfer a portion of the content of the</td><td> 4-17</td>

<td> 10</td><td>vessel 15 to second vessel 15, remainder of vessel 15 continues on process track 28 The contents of the first container 15</td><td> 23</td>

<td> 15</td><td>the first incubation continues (11 minutes)</td><td> 23-17”</td>

<td rowspan="2"> 20</td><td>Introducing and mixing the second reagent with the content of the second container 15 The first container 15 passes through the region</td><td> 2-3</td>

<td>bypass 58B</td><td> 18”-21”</td>

<td></td><td>First incubation (11 minutes) of the second container 15 Introduction of the fourth reagent in the</td><td> 4-17'</td>

<td> 25</td><td>first vessel 15 and mixing (optional, improves chemiluminescent signal total Hb)</td><td> 2”'-3”'</td>

<td></td><td>Separating and washing the second container</td><td> 18'-21'</td>

<td> 30</td><td>Fourth incubation (4 minutes - optional) of the first vessel 15 Introduction of the third reagent in the</td><td> 4”'_-17”'</td>

<td rowspan="2"> 35</td><td>15 second bowl and mix The first container 15 passes through the region</td><td> 2” '-3”'</td>

<td>bypass</td><td> 18”'-21”'</td>

<td></td><td>Third incubation (11 minutes) of the second container 15</td><td> 4”'_-17”'</td>

<td></td><td>The first container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td> 40</td><td>process track 28 to process track 170 Introduction of the pre-initiator in the first</td><td>23 of 170</td>

<td rowspan="2"> 45</td><td>container 15 and mix Separating and washing the second container</td><td> 25</td>

<td> 15</td><td> 18”'-21”'</td>

<td></td><td>Start and read value 1 (total Hb) from the first vessel 15</td><td> 28</td>

<td></td><td>The second container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td> 50</td><td>process track 28 to process track 170 Introduction of the pre-initiator in the</td><td>23 of 170</td>

<td></td><td>15 second bowl and mix</td><td> 25</td>

<td> 55</td><td>Start and read value 2 (GlyHb)</td><td> 29</td>

<td>Referred result =</td><td>value 2 / value 1 X 100</td><td></td>

This format can be used, for example, to determine at least one of the total hemoglobin and ⁶⁰ glycated. Furthermore, this format can be modified not taking into account the first container 15 as in Format E.

IS 2 174 154 T3

Format G

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-23</td>

<td>Transfer a portion of the contents of the container 15 to the second container 15, the rest of the container 15 continues in the process track 28</td><td> 23</td>

<td>The contents of the first container 15 continue the first incubation (11 minutes)</td><td> 24-17”</td>

<td>Introduction and mixing of the second reagent with the contents of the second container 15</td><td> 2-3</td>

<td>Separation and washing of the first container fifteen</td><td> 18”-21”</td>

<td>First incubation (18 minutes) of the second container 15</td><td> 4-17”</td>

<td>Introduction of the fourth reagent in the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 2”'-3”'</td>

<td>Separation and washing of the second container</td><td> 18”-21”</td>

<td>fourth incubation (4 minutes - optional) of the first container 15</td><td> 4”'_-17”'</td>

<td>Introducing the third reagent into the second container 15 and mixing</td><td> 2” '-3”'</td>

<td>Separation and washing of the first container fifteen</td><td> 18”'-21”'</td>

<td>Third incubation (4 minutes) of the second container 15</td><td> 4”'_-17”'</td>

<td>The first container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td>process track 28 to track</td><td>23 of 170</td>

<td>process 170 Introducing the pre-initiator into the first container 15 and mixing</td><td> 25</td>

<td>Separation and washing of the second container fifteen</td><td> 18”'-21”'</td>

<td>The second container 15 is transferred from</td><td>23 ”'from 28 to</td>

<td>process track 28 to track</td><td>23 ”'of 170</td>

<td>process 170 Start and read value 1 (total Hb) from the first vessel 15</td><td> 29</td>

<td>Introducing the pre-initiator into the second container 15 and mixing</td><td> 25</td>

<td>Start and read value 2 (GlyHb)</td><td> 29</td>

Referred result = value 2 / value 1 X 100

For example, this format can also be modified as can be done with Format F. With this modification, this format can be used to determine progesterone, testosterone and estradiol.

IS 2 174 154 T3

Format H

<td>He passed</td><td>Position</td>

<td>Sample introduction</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation</td><td> 4-17”'</td>

<td>Separation and washing</td><td> 18”'-21”'</td>

<td>Transfer of container 15 from the</td><td>23 ”'from 28 to</td>

<td>process track 28 to process track</td><td>23 of 170</td>

<td> 170</td><td></td>

<td>Introducing the pre-starter and mixing</td><td> 25</td>

<td>Second incubation</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

For example, this format can be used to determine, among other things, beta human chorioan gonadotropin (B-hCG), prolactin, progesterone, testosterone, estradiol, and ferritin. It should be noted that almost any item of interest explained here can be determined using this format correctly. Format I

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid</td><td> 1</td>

<td>Introduction of the first reagent in the first container 15, a portion of the first container 15 is moved to the pipettor, the rest of the container continues in the process track 28, leaving all the washing stations bypass, to position 25 '</td><td> 2</td>

<td>Introducing the first reagent into the second container 15 and mixing</td><td> 2-3</td>

<td>First incubation (18 minutes) of the second container 15</td><td> 4-17”</td>

<td>Introducing the second reagent into the first container 15 and mixing (optional, improves the chemiluminescent signal Hb total)</td><td> 2”'-3”'</td>

<td>Separation and washing of the second container</td><td> 18”'-21”'</td>

<td>Fourth incubation (4 minutes - optional) of the first vessel 15</td><td> 4”'_-17”'</td>

<td>Introducing the third reagent into the second container 15 and mixing</td><td> 2” '-3”'</td>

<td>The first container 15 passes through the bypass region 58</td><td> 18”'-21”'</td>

ES 2 174 154 T3 (Continued)

<td>He passed</td><td>Position</td>

<td>Third incubation (4 minutes) of the second</td><td></td>

<td>container 15</td><td> 4”'_-17”'</td>

<td>Introduction of the pre-initiator in the first</td><td></td>

<td>container 15 and mix</td><td> 29</td>

<td>Separation and washing of the second container</td><td></td>

<td> 15</td><td> 18”'-21”'</td>

<td>Start and read value 1 (total Hb) from</td><td></td>

<td>first container 15</td><td> 29</td>

<td>Introduction of the pre-initiator in the</td><td></td>

<td>15 second bowl and mix</td><td> 25</td>

<td>Start and read value 2 (GlyHb)</td><td> 29</td>

Referred result = value 2 / value 1 X 100

For example, in Format I, it is possible to modify the format not taking into account the first container 15 after having transferred the portion of the contents of the container 15 (position 24) to the second container 15. In that case, the format I can be use to determine, for example, folate and vitamin B12.

Format J

<td>He passed</td><td>Position</td>

<td>Introduction of the sample in the</td><td></td>

<td>container 15, possibly with fluid</td><td></td>

<td>thinner</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (27 minutes - four</td><td></td>

<td>times along the process track</td><td></td>

<td> 28)</td><td> 4-47”'</td>

<td>Introduction of the pre-starter and mix</td><td> 25</td>

<td>Second incubation (1 minute)</td><td> 26-28</td>

<td>Home and reading</td><td> 29</td>

For example, the J format can be used to determine, among other things, total hemoglobin.

The embodiments described here also allow sample pretreatment that can be performed in at least two ways, indicated as K and L formats. During the sample pretreatment, the fluid present in the indicated containers 15 can be processed, then no longer they are significant in the pretreatment steps, in any appropriate way, such as any of the formats discussed above. Furthermore, as will become clear later, both formats K and L are applicable in a substantially similar way to the other embodiment of the process path 10 explained below.

IS 2 174 154 T3

Format K

<td>He passed</td><td>Position</td>

<td>Introducing the sample into the first container 15, possibly with diluting fluid</td><td> 1</td>

<td>Introduction and mixing of the first reagent</td><td> 2-3</td>

<td>First incubation (7 minutes)</td><td> 4-23</td>

<td>Transfer a portion of the contents of the first container 15 to the second container 15 in position 1</td><td> 24</td>

<td>Introducing the second reagent into the second container 15 and mixing (optional)</td><td> 2-3</td>

<td>Transfer a portion of the contents of the second container 15 to the third container 15 in position 1</td><td> 24</td>

<td>Inserting the third reagent into the third container and mixing (optional)</td><td> 2-3</td>

For example, the third container 15 can be processed according to at least one of the formats A (to determine, among other things, folate), B, C, H and J.

Format L

Step Position

Introducing the sample into the first container 15, possibly with diluting fluid 1

Introduction and mixing of the first reagent 2-3

First incubation (7 minutes) 4-23

Transfer a portion of the contents of the first container 15 to the second container 15 at position 1 24

Introducing the second reagent into the second container 15 and mixing (optional) 2-3

For example, the second container 15 can be processed according to at least one of the formats A (to determine, among other things, folate, vitamin B12, confirm HBsAb), B, C, H and J.

Given the commonality of the various embodiments of the process path explained and exemplified above, it was appreciated that the assay formats performed in each of the various embodiments are essentially the same. The time intervals are the same. The reagents for a particular assay used in one of the embodiments can also be used in other embodiments.

In considering all of these examples and their common characteristics, it is to be understood that the process path 10, or in other terms the process path 28, has a variable physical length. However, the effective length of the process path 10 is constant in all embodiments. This effective length represents the total distance traveled by the container 15 along the process path 10 during the performance of some determination. The fossil length, that is, the fossil dimensions of the process path 10, is variable, for example, to make the process path 10 fit within a given space. The effective length of the process path 10 is kept constant by moving the container 15 multiple times along the same process path 10 (4 times in the last group of examples). Maintenance of effective length is achieved with the appropriate combination of selective automaotic performance of a given determination process step. In all cases, the

ES 2 174 154 T3 effective length remains constant even though the phase length of a given process path 10 may be shorter than other process paths 10.

It should be noted that all of the above-described embodiments of the process path 10 include and utilize some common elements, such as reagents, a sample / reagent pipettor, a mixer, a wash zone, and a reader. The structural elements are arranged along each embodiment of the process path 10 in such a way that each embodiment is capable of making the same determinations in substantially the same way while keeping the effective length of the process path 10 constant. Each of the process path embodiments executes determinations with approximately the same number of "steps", such as 98 in the previous examples, of the vessel 15 along the process path 10 between sample introduction and reading. . Determination of an item of interest given by one of the process path 10 embodiments takes substantially the same amount of time as a determination of the same item of interest by another process path 10 embodiment. Thus, it is possible to build a structure to make determinations of elements of interest that adapt to the desired phasic dimensions, production requirements, etc., while using the common elements explained here, keeping the effective length of the process path constant.