Integrated diagnostic test system

Technical field [0003] The present invention relates to the field of diagnostic tests, and more particularly relates to diagnostic testing systems using electronic meters.

Background of the Invention [0004] Diagnostic test systems are commonly used to perform various types of diagnostic tests on various types of samples. Diagnostic tests can be qualitative or quantitative tests to determine the presence, concentration or amount of one or more analytes in a sample. An analyte may be a medically significant analyte - e.g., glucose, ketones, cholesterol, triglycerides, human choriogonadotropin (HCG), hemoglobin A1C, fructosamine, carbohydrates, tumor markers, lead, antiepileptic drugs, bilirubin, liver function markers, toxins or their metabolites controlled substances, blood coagulation factors (PT, ATPP) etc. - contained in a biological sample - e.g. blood, urine, tissue, saliva, etc. Nevertheless, the diagnostic test is not limited to the medical field. For example, a diagnostic test may determine the presence or quality of an analyte in water, soil or a chemical sample.

[0005] Such diagnostic test systems may include a test agent (e.g., test strip, plate, disk, etc.) configured to react to the presence of an analyte in a sample, as well as a separate electronic meter configured to cooperate with this test agent to run a diagnostic test and show the results of this diagnostic test to the user.

[0006] To perform a diagnostic test, the user must first obtain the test means for the sample, e.g. a test strip, from the container, and then obtain the sample using a sampling device (e.g. by collecting blood using a lancet), and then apply the sample to the test agent (either before or after inserting agent into the meter interface). The meter then performs a diagnostic test on the sample and indicates the result to the user, e.g. using the numeric display.

[0007] Nevertheless, the diagnostic meter is often massive. In addition, because the user has to grasp and put away the test medium container, sampling device, and then the meter, test medium container, sampling device and meter are easily separated from each other, so that the user can remain without one or more components necessary to perform the diagnostic test. Thus, it is inconvenient for the user to apply a separate container to the test medium, electronic meter and sampling device.

[0008] Furthermore, test agents from different brands or from different production lots can react differently to the presence or concentration of an analyte in a sample. For more accurate results, the electronic meter can be calibrated for a given batch of test strips by providing it with one or more brand-specific or batch-specific calibration parameters that correlate the response obtained with a particular brand or batch of test agents with a certain standardized value reference.

[0009] The user may be required to provide the meter with appropriate calibration parameters in a separate "coding" step. For example, the test media container may display a code number by which the meter can determine the appropriate calibration information. The user can then manually enter the code number (e.g. using buttons or other input devices for user signals located on the meter) in such a way as to bring calibration data to the meter. Alternatively, the calibration data can be loaded into the device, e.g. from the manufacturer's website. As a further concept, the test media container may be provided with a suitable code chip in which calibration data is stored electronically. The user can bring this calibration data to the meter by inserting this code chip into the appropriate port on the meter.

[0010] This coding step can be inconvenient or difficult for the user. For example, older or infirm users may have difficulty loading calibration data or inserting code chips. What's more, the user may forget to calibrate the meter for use with a new brand or batch of test agent. Accordingly, the user may enter incorrect calibration parameters or codes, or the user may use a test brand of one brand or one lot with a calibrated meter for use with a test brand of another brand or from another lot. However, when the meter is calibrated for a given batch of test agent, using this meter with a test agent from another batch may lead to erroneous results that may have serious consequences for the user. For example, when the test is a stand-alone blood glucose test, an erroneous result may misinform the user about his blood glucose level, and this may lead to a diabetic crisis.

Document WO 02/078533 A relates to an integrated sample testing meter, for example for blood measurements, comprising a puncturing device, an electromechanical sensor and a test strip cartridge located in a single modular housing. This test strip cartridge contains a set of test strips, suitable for electrochemical or photometric analysis of a blood sample. This integrated test system automatically dispenses and places the test strip adjacent to the lancet puncture site, automatically transfers the blood sample to the test strip from the lancet puncture site, and automatically analyzes the blood sample after the test strip collects the sample from the puncture site.

[0011] Accordingly, there is a need for diagnostic testing systems that are convenient to wear and minimize the chance that the user will use a diagnostic meter with a brand or lot test agent for which the meter has not been calibrated.

Summary [0012] The present invention meets these and other needs by providing a diagnostic testing system having a meter for performing a diagnostic test on a sample applied to a test agent, and a container configured to contain a test agent compatible with the meter, said meter comprising a closure part for selectively closing the container opening. The present invention further relates to a sampling device, such as a lancet, operating in conjunction with the container in such a way that the user can use the sampling device to obtain the sample without disconnecting the sampling device from the container.

[0013] The present invention also relates to mechanisms for turning off the power source, meter auto-start function, meter diagnostic testing function or other meter function when it has been determined that a triggering event has occurred. A triggering event can be, for example, the expiry of a certain period of time, the passing of a specific date, the characteristics of a certain quality in diagnostic tests, or the use of a certain amount in a test medium. The present invention further relates to mechanisms for reconfiguring the meter to perform a new function when it has been determined that a triggering event has occurred.

[0014] Additional aspects and advantages of this invention will be set forth in the display part below, and will in part become apparent from the description, or may be learned by practicing the invention. The benefits of this invention will be presented and will be understood by the elements and combinations detailed in the appended claims.

[0015] It should be understood that both the above general description and the following detailed description are merely exemplary and explanatory, and are not limiting of the invention as claimed.

Brief Description of the Drawing Figures [0016] The attached drawing figures, which are incorporated and form part of this description, illustrate several embodiments of this invention, and together with the description, serve to explain the basic features of the invention.

[0017] Fig. 1 is a perspective view of a first embodiment of an integrated system according to the present invention.

[0018] Fig. 2 is a perspective view of a second embodiment of an integrated system according to the present invention.

[0019] Fig. 3 is a perspective view of a third embodiment of an integrated system according to the present invention.

[0020] Fig. 4 is a block diagram illustrating the functional components of a diagnostic meter according to the present invention.

[0021] Fig. 5 is a cross-sectional view of the integrated fourth embodiment of the integrated system of the present invention.

Description of Embodiments [0022] Reference will now be made more specifically to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used in all figures to designate the same or similar parts.

[0023] 1. Integrated system [0024] Fig. 1 shows an integrated system 100 for performing a diagnostic test in accordance with an embodiment of the present invention. This exemplary integrated system 100 includes a container 110 for accommodating a test agent, such as test strips 120, as well as a meter 130, for performing a diagnostic test using the test strips 120 contained in the container 110.

[0025] In one illustrative embodiment, the diagnostic test is a determination of the amount of blood glucose in a whole blood sample applied to the sampling chamber 121 of the test strip 120. For blood glucose testing, the meter 130 may use any of a variety of techniques. Preferably, an electrochemical technique (e.g., coulometry, amperometry, potentiometry, etc.) is used in the diagnostic test. Exemplary electrochemical systems are described in the earlier application US 2003/203498 filed November 1, 2002, as well as US 2005/045476 filed April 21, 2003, both of which are entitled "System and method for blood glucose testing" and both have this same assignee as in the present application. Alternatively, a photometric technique (e.g. reflection, transmission, dispersion, absorption, fluorescence, electrochemoluminescence, etc.) to determine the amount of glucose in the sample. Exemplary photometric systems have been described in patents US 6,201,607, US 6,284,550 and US 6 541 266, each of which has the same user as the present application. However, electrochemical techniques are currently preferred because of, inter alia, that they require a smaller blood sample (on the order of 1 μL or less) than photometric techniques (on the order of 1 μL or more). Furthermore, the instruments for electrochemical techniques typically require less energy and can typically be made more compact than the instrumentation for photometric techniques.

[0026] The integrated system 100 will be illustrated with reference to a diagnostic test for determining blood glucose using an electrochemical technique, it being understood that the basic features of this invention are equally applicable to other types of diagnostic tests and techniques as mentioned above. Moreover, although the present invention has been illustrated as employing a test agent in the form of test strips 120, embodiments of the present invention are not limited to a particular type of agent, and those skilled in the art will be aware that the basic features of the present invention are equally applicable to 5 gnostic test systems that use test means in a different form, e.g. in the form of plates, discs, etc.

[0027] The meter 130 is contained within the housing 131. The meter housing 131 is attached to or otherwise comprises a closure portion 140 (lower portion of the meter 130 in Fig. 1) which is coupled to the container 110 to selectively close the container 111. The opening 111 may be the only opening in the container 110. In one illustrative embodiment, the meter housing 131 has one side (e.g., the bottom portion of the meter housing 131 in Fig. 1) which is shaped to fit into the closure 140 and is attached to the closure 140, e.g., by mechanical fastening (clamps, etc.), binding, gluing, welding, etc. Alternatively, a part of the closure 140 may be integrally formed with the housing The meter 131, Meter 130 and closure 140 thus together form a cap or lid for container 110.

[0028] The closure 140 may be configured to engage the container in several ways. In the closed position (see Fig. 3), the closure 140 closes the opening 111 sufficiently to prevent the loss or removal of test means from the container 110. Therefore, the closure 140 is configured to engage the container 110 in such a way that prevent test strips 120 from entering the opening 111 when the closure 140 is in the closed position. The container 110 and the closure 140 may also be configured to prevent light, liquid, vapor and / or air from entering the container to prevent contamination or degradation of the test means. When the test means are configured so that they are toxic or may contribute to a choking risk, the closure 140 can be optionally configured in such a way that it is child-proof to prevent children from opening the container 110 and gain access to the means test. For example, the closure 140 and the container 110 may be configured in a manner similar to well-known child-proof containers for pharmaceuticals or household chemicals.

[0029] The closure 140 may be configured as a nut, e.g., by making mutually engaging threads (not illustrated) on the closure 140 and on the container 110. Alternatively, the closure 140 may be configured to slide on the opening, e.g. inside the grooves (not shown) next to the hole. As a further alternative option, the closure 140 may be provided with a latch (not shown), such as a latch that engages with the container 110 (or vice versa). This latch can be released by a button. However, in one illustrative embodiment, the closure 140 is configured to form a pressure seal with the container to seal the opening against the ingress of light, liquid and vapors. For example, in Fig. 1, the closure 140 is configured with a recess (not shown) to press against the outer portion of the opening 111, whereby the opening rim 111 is fitted within the closing portion 140. Alternatively, the closure 140 may be configured with a projection 241 shaped to engage the inner portion of the opening 111, as shown in Fig. 2. Nevertheless, it will be understood that the present invention is not limited to any

- particular container and closure configurations, as well as other configurations in accordance with the basic features of the present invention can be used.

[0030] To facilitate manufacturing, the opening 111 can be made in the same shape as the container 110. The housing 131 of the meter 130 likewise preferably has an external shape similar to the shape of the container 110, whereby this integrated system can be conveniently held and worn, e.g. user's pocket. However, it will be understood that the container 110, the meter 130 and the opening 111 need not have the same outer shape, while the container and the meter may be configured in different shapes without departing from the scope of the present invention.

[0031] Preferably, the container 110 is a substantially straight round cylinder, while the opening 111 is circular in shape, as shown in Figs. 1 and 2. The circular shape is one of the possible configurations for the opening because it allows the formation of an evenly pressed seal with a pressure fit. between the closure part 140 and the container

110. As shown in Figs. 1-3, the meter 130 may also be substantially circular and cylindrical and have a similar width to the width of the container, so that the integrated meter 100 has an overall essentially circular-cylindrical shape that is comfortable to hold and wear, e.g. in your pants pocket. However, the container 110, the meter 130 and the opening 111 can be made in any of several other shapes. For example, the container can be made as a simple, oval, ellipsoidal or rectangular cylinder, to better fit it into the user's pocket.

[0032] The container 110 and the closure 140 may also be provided with respective flanges 112 and 242, respectively, which are flat fitted together when part of the closure is in the closed position to further prevent the ingress of liquids and vapors. The closure 140 is also preferably provided with a projection 143 that extends beyond the side of the container 110 sufficiently to assist the opening and closing of the container 110 by the user, e.g. by pushing the projection 143 with the thumb. The projection 143 may be an extension of the collar 242 as shown in Fig. 2. Alternatively, the projection 143 may be formed directly on the meter housing 131 as shown in Fig. 3.

[0033] As shown in Fig. 1, the container 110 can be opened by completely removing the meter 130 and parts of the closure 140 from the container 110. Alternatively, the meter 130 and / or the closure 140 can be connected to the container 110 to prevent separation meter 130 from the container. The container 110 and the meter 130 may be connected by e.g. a hinge, cable or other flexible connector, such as a plastic belt or hose etc. (not shown). In one illustrative embodiment, the hinge 251 connects the container 110 and the meter housing 131 and / or the closure 140. Hinge 251 is positioned such that the projection 241 fits inside the opening 111 in the closed position. The connector (e.g., hinge 251) may have one end connected to the container 110 and the other end connected to the closure 140 and / or meter housing 131. For example, container 110 and closure 140 may be integrally connected through a hinge, e.g. as depicted in US Patent 5,723,085, entitled "Process and apparatus for making a leak proof cap and body

- 7 assembly. " Alternatively, one end of the connector (e.g., hinge 251) may be connected to a ring 252 that is dimensioned so that it fits onto container 110 as illustrated in Fig. 2. Ring 252 can be configured to be loosely frictional coupled to container 110. As a further alternative concept, ring 252 can be attached to container 110, e.g. by welding, gluing, etc.

[0034] In one embodiment, the container 110 and the closure 140 are made of polypropylene using an injection molding process. However, other materials and processes may be used without departing from the scope of the present invention.

[0035] The integrated system 100 may further include a sampling device that the user may use to obtain a sample for the test. The sampling device may be adapted to obtain a biological sample. For example, the sampling device may be a lancing device that the user may use to collect blood, e.g., for a diagnostic blood glucose test.

[0036] An example of an integrated system comprising a lancing device 360 ​​is shown in Fig. 3. An exemplary lancing device 360 ​​includes a rear body 312, a finger cover 314, an external nozzle 318, an internal nozzle 322 and a trigger 324. The exemplary lancing device 360 ​​further includes an internal spring ( not illustrated), which is used to drive the lancet 320 beyond the contact surface 321 and through the skin, to a depth selected by the user.

[0037] As shown in Fig. 3, an exemplary lancing device 360 ​​is connected to the container 110. The lancing device 360 ​​can be permanently connected to the container, for example by forming the rear body 312 of the finger cover 314, the outer nozzle 318 or the inner nozzle 322 integrally with the container 110, or by combining one of these components with the container 110, e.g. by mechanical fastening (clamps, etc.), binding, gluing, welding, etc. Alternatively, the lancing device 360 ​​can be detachably connected to the container 110 by using suitable releasable connectors on the lancing device 360 ​​and the container 110. For example, the lancing device 360 ​​may be provided with one or more slots, holes or clamps that are engaged with the respective structures on the container 110 or vice versa. As a further alternative concept, the lancing device 360 ​​may be connected to the housing 131 of the meter 130, or to a portion of the closure 140. Preferably, only one of the rear body 312, finger cover 314, outer nozzle 318 or inner nozzle 322 is connected to the container 110, as a result of which the lancing device 360 ​​can be adjusted and used without detaching it from the container 110.

[0038] To sample using the exemplary lancing device 360, the user may first select the desired penetration depth of the lancet 320 by rotating the outer nozzle 318 in such a way that the corresponding depth 326 indication on the outer nozzle 318 is aligned with the arrow 328 on the inner nozzle 322 . Then, the user stretches the inner spring by pulling the inner nozzle 322 away from the rear body 312 and places the contact surface 321 against the surface to be cut.

The user may then actuate the trigger 324 to release the internal spring that pushes the lancet 320 beyond the contact surface 321 to the indicated depth and thereby to the skin. The blood sample can then be applied to the sampling chamber 121 of the test strip

120.

[0039] Further details of an exemplary lancing device 360 ​​were set forth in earlier application US 2005/159768 entitled "Lancing device", filed January 15, 2004, having the same assignee as for the present application. However, the present invention is not limited to any particular device, and a person skilled in the art will be aware that other sampling devices may be used in a manner similar to the exemplary lancing device described above.

[0040] 2. Meter electronics [0041] Fig. 4 is a block diagram illustrating the functional components of an exemplary meter 130. As shown in Fig. 4, the meter 130 includes a controller function 400, a means interface 410, a power source 420, a function user control 430, input / output function 440, indicator function 450, dispensing mechanism 460, voice function 470, as well as ambient sensors 480. In one illustrative embodiment, the functional components of the meter 130 are contained within the meter housing 131.

[0042] The controller 400 controls the operation of the functional components of the meter, according to its instructions 402, which can be provided as external or internal software. The controller 400 may include the functions of a 404 processor, 406 memory, and a 408 clock. In one illustrative embodiment of this invention, the functions of the 404 processor, 406 memory, and / or clock 408 may be implemented using an ASIC [Application Specific Integrated Circuit] that allows the size of the 400 controller to be reduced compared to standard technology integrated circuits. Nevertheless, it will be understood that the controller may be implemented using standard integrated circuit technology or other technology without departing from the scope of the present invention.

[0043] The function of the processor 404 executes the instructions 402 used to control the functional components 410 - 480 of the meter 130. More specifically, the processor 404 executes the instructions 402 necessary to perform the diagnostic test (e.g., as specified in application US 2003/203498 and US 2005/045476 ). These 402 instructions for the 404 processor can be stored in memory 406 or anywhere else. The memory function 406 can also store data such as calibration data and other data used when performing the diagnostic test. In embodiments of the present invention, memory 406 is used to store diagnostic test results, including a time stamp and / or an associated voice message, for later analysis or loading (discussed below).

[0044] The clock function 408 regulates the execution of the instruction 402 by the processor over time. More specifically, the clock function 408 is used to regulate synchronization

- 9 temporary stages of diagnostic test. For example, processor 404 may use a clock 408 to regulate the incubation period, or other periods of time necessary for the diagnostic test to be performed correctly (e.g., as reported in US 2003/203498 and US 2005/045476). The 408 clock function can be implemented by a single system clock or by a number of clocks for different tasks.

[0045] The means interface 410 adopts test means, such as test strips 120, for testing and includes a channel 411 to ensure that these test means are positioned correctly after insertion by the user or dispensing mechanism 460. The interface 410 includes one or more means sensors, for determining e.g. whether the test strip 120 has been correctly inserted into test port 410 (i.e., whether the interface side 122 of the test strip 120 has been correctly positioned relative to the center sensors); whether a suitably sized sample has been applied to the sampling chamber on this sampling side 121 of the test strip; and the presence or concentration of the analyte in the sample. For meters that use electrochemical techniques, the media sensors may contain one or more electrical contacts, corresponding to the electrodes on the interface side 122 of test strip 120. For meters that use photometric techniques, at least the presence or concentration of the analyte in the sample is determined using an optical sensor, e.g. light emitting diode and a suitable photodetector.

[0046] The power source 420 provides energy for the electronic components of the meter 130. In one illustrative embodiment, the power source is a lithium disc battery. However, other power sources, such as other types of batteries, solar cells or AC / DC converters can be used without departing from the scope of the present invention. The power output of the power source can be regulated, e.g. by a voltage control circuit.

[0047] The user control function 430 may include, for example, one or more buttons, switches, keys or other control elements for controlling the functions of the meter 130. In one illustrative embodiment, the user control function 430 is implemented by one or more. buttons 132, located on the left side of the meter housing 131 (see Fig. 1). In this position, the button 132 can be comfortably pressed with the right thumb or forefinger while this integrated system 100 is held by the right hand with the display 133 in an upright position. However, user control 430 can be located anywhere on meter 130. For example, the button 132 may be located on the right side of the meter housing 131 to improve convenience for left-handed users, or on the top of the meter, e.g. centered under the display 133. As a further example, user control function 430 may include a switch activated when the user opens the closure 140, e.g. such that the meter 130 automatically turns when the user opens the container 110 to obtain a test strip.

[0048] In one embodiment of the present invention, the user control function 430 is implemented using a single control element, e.g. a single button 132, which is used to control a number of functions

- 10 meter. For example, user control 430 may be used to control the input / output function 440, indicator function 450, dispensing mechanism 460, and / or voice message function 470, by providing requests for these functions directly or through the controller 400. User control 430 can also be used to control the diagnostic test function of controller 400. For example, when a test is to be performed using a control solution (e.g., as reported in applications US 2003/203498 and US 2005/045476), the button 132 may be held down to indicate to the controller 400 that the current sample is a control solution and with this controller 400 should perform a control test on the current bar.

[0049] Alternatively, a number of user controls may be used, e.g. a number of buttons 132, each button having different functions. For example, two buttons may be used to allow the user to view diagnostic test results stored in memory 406 in the forward or reverse direction. To facilitate user operation, the function of the button or buttons 132 at a certain point can be dynamically indicated by the indicator function 450. For example, when viewing the results of previous tests, the indicator function 450, e.g. display 133, may instruct the user to "Press the button, to watch the next result. " Moreover, user controls 430 may have different functions at different times. For example, holding down the button 132 after inserting the test strip into the 410 interface of funds may be a request for the controller to perform a control test on that strip, while holding the button without inserting the test strip may be a request for the controller to display the results of a previous diagnostic test.

[0050] The input / output function 440 contributes to the loading of data or instruction 402 into the meter 130, and / or the loading of data from the meter 130. The input / output function 440 can be used, for example, to load the results of a diagnostic test or diagnostic tests in such a way so that they can be transferred to a carrier device or to a third party, e.g. a medical service provider, for use in the treatment of the user. Alternatively, the I / O function 440 can be used to load data (e.g., calibration data) or instruction 402 (e.g., updated software) to meter 130. Loading to or from a data device and / or instruction has been further elucidated in the earlier application WO 01 / 63886 entitled "Systems and methods for communicating data from meters", filed February 25, 2000, having the same contractor as the case in question. The I / O function 440 can be implemented using any conventional digital or analog information interface, e.g., serial port, parallel port, optical port, infrared interface, etc.

[0051] The function of the indicator 450 indicates the result of the diagnostic test to the user, e.g. a numerical value together with the units of measurement. In addition to the indication of the diagnostic test result, the indicator may present other information to the user. For example, the indicator 450 may indicate the average result of a number of tests, time and / or date, battery status remaining to be used, etc. (e.g. as reported in application US 2003/203498 and US 2005/045476). The indicator 450 can also be used to encourage the user

- 11 to perform specific stages of the diagnostic test, e.g., to apply a sample to the test strip 120. In one embodiment of the present invention (discussed below), the indicator 450 indicates the number of test strips remaining in container 110, or the number of tests or time remaining to when meter 130 stops working.

[0052] The indicator function 450 may present information in visual, acoustic or tactile form. For example, the indicator 450 may include a display 133 for displaying information, e.g., using numeric values, words, and / or icons. Several different technological solutions can be used in the 133 display. For example, the display may be a liquid crystal display, a vacuum fluorescent display, an electroluminescent display, a display with light emitting diodes, a plasma display, etc. In the illustrative embodiment, the display 134 is a liquid crystal display. Alternatively or additionally, the indicator 450 may include an audible indicator configured to denote information with sound. For example, the indicator 450 may include a loudspeaker connected to the voice and / or sound circuit to, e.g., give a diagnostic test result or indicate with a buzzer that an error has occurred. As part of another alternative concept, the indicator 450 can be implemented as a dynamic braille indicator suitable for the blind.

[0053] In one illustrative embodiment, the function of the indicator 450 includes a display 133 and a loudspeaker connected to the sound circuit (not shown). The display 133 may be located on the top of the meter housing 131, as shown in Figs. 1 and 3. In this position, the display 133 is conveniently visible when the meter is gripped in the hand with the thumb or forefinger on the button 132.

[0054] Because diagnostic test means, e.g. test strips 120, are typically very small, it may be difficult for some users to remove such test means from container 110. Therefore, the dispensing mechanism can be used to cause automated dispensing of funds from the container.

[0055] Fig. 5 is a cross-sectional view of an exemplary integrated system having a dispensing mechanism 460. In this embodiment, the container is configured as a spring loaded magazine 510. A number of test strips 120 are stacked on top of each other in magazine 510. Magazine 510 may have an internal shape similar to that of the test means to maintain stack alignment. For example, in the case of the test strips 120 illustrated in Fig. 1, the inside of the magazine 510 may have a substantially rectangular cross-section.

[0056] The spring 516 pushes this stack of test strips towards the top 518 of the magazine 510, the upper test strip 125 operatively positioned relative to the strip dispensing mechanism 460. The dispensing mechanism 460 dispenses the upper test strip 125 in the stack using linear and / or rotational mechanical action . Mechanical action can be performed manually (e.g. by pulling the slider or rotating the disc by the user) or by the motor (e.g. stepper motor) activated by the user control function 430. The upper test strip 125 is ejected from the stack and the slot 520 is crossed. The test means used with this embodiment can be modified by using a friction-suppressing slide coating or film, such as TEFLON, on one or both sides to ensure smooth ejection.

[0057] When a specific diagnostic test requires that the test strip be inserted into the means interface 410 before the sample is applied, the dispensing mechanism 460 may place the interface side 122 of the ejected test strip 125 inside the means interface 410, e.g. with the test strip interface 122 coupled to the center sensors and the test strip sampling chamber 121 extending out of the meter 130 in such a way as to allow sample application as shown in Fig. 5. Alternatively, the dispensing mechanism 460 may simply extend any end of the test strip 125 toward the user, which may then manually insert the test strip 125 into the media interface 410 (either before or after sample application, depending on the requirements of the particular diagnostic test). The controller 400 may be instructed to count the number of test strips 120 issued by the dispensing mechanism 460 and cause the indicator function 450 to indicate e.g. the number of test strips 120 remaining in the magazine 510.

[0058] Voice message function 470 may be used to record a voice message associated with a given diagnostic test result. For the purposes of, for example, self-testing of blood glucose levels, the user may use the 470 voice prompt function to record information about his diet at a time corresponding to the diagnostic test. A voice message can be stored in memory 406 together with an indicator that assigns it a particular test result. The use of the 470 voice message function has been more fully explained in an earlier application US 2005/165622, entitled "Medical diagnostic testing device with voice message capability", filed January 26, 2004, having the same assignee as in the present application. At the end of the useful life of the meter 130, the meter 130 itself may be handed over or sent to the unit providing medical services to the user. The medical service provider can then review the results of diagnostic tests and / or associated voice messages for use in treating the user.

[0059] The ambient detection function 480 may include one or more ambient sensors used to collect data used in performing the diagnostic test. Such ambient sensors may include e.g. a temperature sensor and / or a humidity sensor. For example, the meter 130 may use a temperature reading to correct the diagnostic test result for a temperature relationship (e.g., as reported in application US 2003/203498 and US 2005/045476). As a further example, the meter 130 may use the humidity reading to determine if the humidity level is too high to perform a diagnostic test.

[0060] 3. Prevention of the use of incorrect test strips [0061] The meter 130 can be calibrated for use with a particular brand or batch of the test agent manufacturer by adjusting the diagnostic test performed by the meter 130 for a particular brand or lot, using one or more calibration parameters. These calibration parameters may include environmental corrections (e.g. temperature corrections), time period corrections (e.g. with respect to incubation time), voltage corrections (e.g. for use in electrochemical tests), color changes (e.g. for use in photometric tests), etc., which adapt the diagnostic test function of the 400 controller to a particular brand or batch of test agents. See, e.g., application US 2003/203498 and US 2005/045476.

[0062] In one illustrative embodiment of the present invention, the integrated system 100 includes one or more containers 110 or magazines 510 of test strips 120, packaged together with the meter 130. These 120 test strips in the package are from the same production batch or otherwise have the same blood glucose response characteristics, so that the 130 meter can be calibrated once and then can be used with any of the 120 test strips in the package without calibration .

[0063] The diagnostic test function of the packed meter 130 may be pre-calibrated by the manufacturer or distributor, e.g., by providing instructions 402 and / or data adapted to the appropriate test means. Alternatively, the meter 130 can be calibrated at the user level by requiring the user to calibrate the meter with respect to a particular brand or batch of test agents prior to using the meter to perform diagnostic tests. For example, the user may use the user control 430 or the input / output function 440 to enter or load calibration data or code into the device from which the controller 400 can obtain calibration data. In another alternative concept, each container 110 for test agents (or a combined packaged group of containers from the same batch) may be provided with a data carrier that electronically stores calibration data. See e.g. application US 2003/203498 and US 2005/045476. To calibrate the meter for test means in a specific container 110 or package, the user simply plugs the appropriate data carrier device into the connector (not shown) on meter 130. The controller 400 then obtains the necessary 402 instructions or data from the data carrier device. Nevertheless, it is very effective from a distribution point of view and very convenient from a user point of view when the meter 130 is pre-calibrated for use with total packaged test strips 120 prior to distribution to the user.

[0064] Since the use of the meter 130 with test agents from a certain brand or from a certain batch for which the meter 130 has not been calibrated may lead to errors, examples of the present invention minimizing the chances that the user will misuse the meter 130 with branding agents or lots for which the 130 meter has not been calibrated. In one illustrative embodiment, the functional components of the meter 130 have been selected and constructed in such a way that the meter 130 is economical for market sale as a disposable device. For example, the meter 130 may be constructed using low-cost components, or one or more functional components of the exemplary meter 130 described above may be omitted to reduce the overall cost of the meter 130. For example, the meter may be constructed without e.g. input function / output 440, dispensing the mechanism 460, voice message function 470, and / or

- 14 ambient sensors 480. Furthermore, the test means and meter 130 can be packaged together in such a way that the user receives a new meter 130 with each purchase of the test means. Consequently, the user is encouraged to discard his old meter 130 when the test means packaged with the meter (e.g. container 110) have been used up. In this way, embodiments of the present invention reduce the likelihood that the user will misuse meter 130 with test means from brands or lots for which meter 130 has not been calibrated.

[0065] Illustrative embodiments of the present invention also show one or more preventative measures that are configured to further minimize the chance that the user will incorrectly use test means for which his meter has not been calibrated. Such preventive measures may disable one or more meter functions upon the occurrence of specific triggering events. For example, a preventive measure may cause meter 130 to be turned off completely after such meter 130 has been used for a certain period of time or for a number of tests, or with a number of test means. The meter 130 can then simply be thrown away or returned to the manufacturer for processing. Alternatively, the preventive measure may cause only the diagnostic testing function of the controller 400 to be disabled, or simply preventing the meter from displaying the diagnostic test result. The user can then stop the meter 130 to use its other functions.

[0066] A given preventive measure may be triggered by a triggering event, such as a certain period of time. Such a period of time may be associated with specific test means, e.g., a specific container 110 or batch of test strips 120 for which the meter 130 has been calibrated or otherwise adapted. For example, a precautionary measure may be triggered if the current date is after the expiration date of the test means associated with the 130 meter, e.g. when the manufacturer indicates that certain test means should not be used later than two years after their date of manufacture. Alternatively, the expiry date can be determined in relation to the date when the container was opened, e.g. when the manufacturer indicates that the test means should not be used later than 2 months after their container 110 was first opened.

[0067] The date when a particular container 110 of test agents was first opened may be estimated or determined in a number of ways. When the meter 130 has been pre-calibrated for use with a single container or batch of test strips, the date when the container was first opened can be estimated by determining the date when the meter was first started, e.g. by instructing the controller 400 to save data or start the timer when the meter 130 was first started. However, due to the fact that the user can run the meter (e.g. familiarize yourself with the functions of the meter or to calibrate the meter) indefinitely before actually using the meter to perform a diagnostic test, it is recommended that the date of first use of the meter is estimated by instructing the controller 400 to keep the date or start the timer when the meter 130 is

- 15 was used for the first time to carry out a diagnostic test. Similarly, when the meter 130 is calibrated by the user, the date when the specific container is opened can be estimated by instructing the controller 400 to save the date or start the timer when the meter 130 is first used to perform a diagnostic test after calibration or in a different degree of adaptation to a given number of test strips. Alternatively, when the meter 130 is attached to a particular container 110, the user control function 430 may include a switch actuated when the user opens the closure 140, e.g., in such a way that the controller is notified when the container 110 is first opened.

[0068] The period of time need not be associated with a particular batch or container of test means. A specific preventive measure may be triggered at a predetermined time after manufacture or first use of the meter 130, or for the first time a specific function of the meter has been used (e.g., performing a diagnostic test), regardless of any characteristics of the test means. For example, a given preventive measure may be triggered three months after the first use of the meter to perform a diagnostic test. In either case, the indicator function 450 can be used to indicate the time remaining to run the preventive measures.

[0069] Alternatively or additionally, the controller 400 may maintain counting the number of test means used or the number of diagnostic tests performed by the meter using current calibration data. The number of test agents used can be estimated by the number of times test agents have been inserted into the 410 agent interface, or preferably the number of times a sample has been detected, e.g. by means sensors. The calculated result can be compared with the number of tests or test means allowed before the preventive measure was activated. The allowable number may refer to the number of test media that were originally packaged with the meter 130 by the manufacturer or distributor, e.g. the number of test media originally contained in the appropriate container 110. As a further alternative concept, the permissible number may exceed the number of test strips contained in the appropriate packaging or container 110 by a small amount, e.g. 10%. If the calculation result exceeds the working quantity, then a precautionary measure may be initiated. The indicator function 450 can be used to indicate the number of diagnostic tests or test means remaining before the preventive measure is activated.

[0070] Information related to the activation of the preventive measure (e.g., allowable period of time, expiry date of the respective test means, number of diagnostic tests, number of diagnostic test strips, etc.) can be obtained in a manner similar to calibration data. In one illustrative embodiment of the invention, the controller 400 distributed together with the triggering information, e.g., encoded in memory 406 or anywhere else in the controller 400. Alternatively, trigger information may be input by the user. For example, trigger information can be attached to calibration data that is entered or loaded into the device by the user. Alternatively, the user may enter or load trigger information into the device

- 16 (or code from which the controller 400 can obtain trigger information) separately from the calibration data.

[0071] The controller 400 may be instructed to periodically determine whether a specific preventive measure has been triggered. For example, the controller 400 may determine whether the preventive measure is running daily or weekly. Alternatively or additionally, the controller 400 may be instructed to determine if a given preventive measure has been activated each time an event occurs. For example, the controller 400 may be instructed to determine whether a given preventive measure has been activated each time the test strip 120 has been inserted into the test strip interface 110, when the sample is detected by the means sensors, when the diagnostic test is performed by the controller when the diagnostic test result is displayed, or when a specific user 430 control or other meter function 130 is started, etc.

[0072] Preventive measures may take several forms. When the power source 420 is limited (e.g., battery), the precautionary measure may manipulate the life of the power source 420 in such a way that the power source, e.g., the battery within the housing 131, is turned off shortly after the preventive measure is actuated. For example, the controller 400 may increase the load on the power source when the precautionary measure is activated. The load can be increased, e.g. by increasing the clock frequency of the 408 system clock in such a way that the rated power is consumed by the controller 400 while for other electronic functions it decreases. The power source 420, and thus the meter 130, will then be turned off in a relatively short period of time. Alternatively or additionally, the controller 400 may be instructed to cause the meter 130 to remain on when a precautionary measure is activated and thus the power source is depleted. As part of another alternative concept, the controller can be instructed to open the switch or blow the fuse in such a way as to disconnect the power source 420 from the electronic functions of the meter 130. In this embodiment, the meter housing 131 can be constructed in such a way that the power source 420 is not interchangeable. The indicator function 450 may indicate the estimated time remaining until power source 420, and thus meter 130, is turned off.

[0073] Another preventive measure may prevent the diagnostic test being performed. For example, when the meter 130 includes an auto start function to start a diagnostic test after inserting the test strip 120 into interface 410 (e.g., as reported in application US 2003/203498 and US 2005/045476), the controller 400 may be instructed to disable the automatic function run when the preventive measure is run. The controller 400 may, however, allow the user to turn on the meter via a user control function 430 to allow access to other meter functions. For example, the controller 400 may allow the user to start the meter and view the results of previous tests and / or and or associated voice messages stored in memory 406.

[0074] As a further alternative concept, the preventive measure may allow a diagnostic test to be performed, but prevent the indicator function from indicating the result. Instead, the meter may display a message indicating that the meter is not calibrated and / or that the meter needs to be replaced. Again, as in the previous case, the controller 400 may still allow the user to view the results of previous tests and any associated voice messages stored in memory 406. The meter 130 itself may then be forwarded or sent to the medical service provider. This service provider may then review diagnostic test results and / or associated voice messages for use in treating the user.

As a further precautionary measure, the controller 400 may be instructed to reconfigure the operation of the meter 130. For example, the controller 400 may be instructed to reconfigure the function of the indicator 450 to indicate other information in place of the diagnostic test result. For example, the function of the indicator 450 may be reconfigured to indicate the time and / or date. Alternatively, the function of the indicator 450 may be reconfigured to indicate readings from the ambient sensors 480. For example, the meter 130 may indicate temperature and / or humidity, including the respective units, on the display 133. As a further alternative concept, the controller may be instructed to reconfigure the voice prompt function so that voice messages can be saved outside the context of the diagnostic text.

[0076] The user control function 430 may be reconfigured according to how the indicator function is reconfigured. For example, the indicator function 450 can be reconfigured to act as a timer, e.g. a kitchen timer. The user control 430 can be reconfigured accordingly to control the timer. For example, the user control 430 may be reconfigured to start and stop the timer. Alternatively, the user control 430 may be reconfigured to allow switching or adjustment of the time, date, temperature and / or humidity display.

[0077] The meter may be provided with a fastening element (e.g. magnet, Velcro fastener, adhesive etc.) on its rear side to allow the user to place the meter 130 where its new function will be useful. For example, the user can place the meter on his refrigerator. In this way, the user may be reminded of the manufacturer's or distributor's name and / or logo (which may be placed next to the display 133) in context outside of using the meter 130 for diagnostic testing.