Method for analysing a sample on a test element and analysis system

[0001] The invention relates to a method of analyzing try on a test element in an analytical system, in particular to measure the concentration of glucose in a body fluid on a test strip. [0002] For analysis tests, for example, body fluids, blood or urine, analytical systems used for analysis will find for too too too too. . Optical, especially photometric and electrochemical analysis of test elements is the most common way to quickly determine the concentration of analytes in probes. Analytical systems with test elements will generally provide analytics, environmental analytics and, above all, medical diagnostics. Especially in the diagnostics of blood sugars, in capillary blood, test elements that are photometrically or electrochemically analyzed are of great importance.

[0003] There are various forms of test elements. Článok 4 The pole test is to be carried out, the pole test is to be carried out. Diagnostic Test Itemse, które köktałtowane w postaci pasów określane jožki paski testki. DE-A 197 53 847, EP-A 0 821 233, EP-A 0821234 lub WO 97/02487. Przedmiotowy wynalazek odnosi się do elementów testowych dowolnej postaci, zwłaszcza Paskowych elementów testowych.

[0004] W e stanie techniki znane element y y test pr ow ow ó,,,,,,,,,,,,,,,,,,,,,,, element,,, pole pole pole pole pole pole pole pole pole pole pole pole pole pole Taki element testowy jest przyk the subject of description DE 197 53 847 A1.

[0005] For the analytical examination of one try on a test element, prior art analytical systems of test elements that contain a test element takeover position for positioning a test element and for a for a for.

[0006] Description WO 00/19185 A1 discloses a method for analyzing photometric test elements comprising

- a lighting unit with at least one first and one second light source,

- the basis for taking over the test item with the evidence zone in such a way that the evidence zone is positioned relative to the lighting unit,

- a detective jet with at least one detector that detects light reflected from the evidence area or passed through the evidence area,

- a control unit that activates both light sources and accepts the signal generated by the detection unit; and - an analytical unit with live nutritious lines.

[0007] To keep the elements for test in the analysis position, the positioning device has a slidly hinged pin with a tapered end. For proper positioning, the tip of the pin is in the test element recess so that the test element is fixed and positioned towards its longitudinal axis. The spigot can also be used to signal electrically the presence of the test element or its positioning. For this purpose, the plug is made of an electrically conductive yak, and for example a contact is provided on the opposite surface of the device. In the absence of a test element, the pin is pressed into contact with a spring and an electric contact is created between the two elements. If the test element is now inserted, it first moves between the pin and the contact, so that the electrical contact is broken. On further insertion, however, the plug extends through the groove of the test element and the electrical contact closes again. For example, the contact can also be activated via the lateral boom boom.

[0008] Many known analytical systems, positioning the test element relative to the analytical unit is critical, especially in the case of optical analysis of test elements. The relative positioning of the stock analyzer, the test element to the optical analytical system is decisive for the accuracy and correctness of the measurement carried out for the analyzey test in the Analysis area.

[0009] To guarantee correct positioning, many solutions are available in the prior art. The tool holder according to WO 00/19185 A1 secures the positioning of the test element in the longitudinal direction (X direction) by meshing the pin in the test element selection. For positioning in the transverse direction (Y direction) the holder has guide elements. In the PRzypadku milk oprawki i roswnie In the case of many other test element holders, however, incorrect positioning perpendicular to the Analysis area (Z direction) cannot be ruled out in analytical systems. For example, the user can thus raise the test element on the opposite side of the plug so that the positioning of the Analysis area changes so that the Analysis result is falsified. Even in the case of the holder at both ends of the test Elementum strip, for example through the spigot meshed at One end and through the clamp adjacent to the upper surface of the Test Elementum, at the Drug end, an incorrect position of the analysis area in the Z direction may occur, if the test element is bent between both retainers. Therefore, it is required that the analytical system for analyzing the testo on the test element can detect such incorrect positioning that the exclusions of the indication of the erroneous analytical results transmitted by the analytical system. [0010] DE 199 32846 A1 describes a method for detecting incorrect positioning of a test strip, an optically analyzer in a measuring instrument for the measurement of a substance, the liquid intended for the conductor being carried out behind the passage for the lead. test field transmission is recorded and analyzed. In this case, the measuring field assigned to the test strip test field is divided into at least two areas that use one another the other in the second test bad bad and bad and bad and test strip in at least one lying area in front of the test field, looking at the insertion hole, there are zones with different reflection and transmission capability,

EP 1 921 441 B1 following in the direction of insertion. The created difference of measured values ​​obtained for both measuring areas is compared with the set threshold value. When the threshold value is exceeded, a signal is generated indicating the erroneous position. There, however, is only used to detect incorrect positioning in the X or Y direction.

[0011] Description EP 1 213 579 A2 relates to a system for analysis, liquid test through analysis, element test test with the help of an analytical unit, where the element testza for for for for too for too too too too for whether the analysis area of ​​the test element is positioned as intended in relation to the analytical unit. The position control unit includes a light source for irradiating the surface of the test element, preferably an array of analyzes, a detector for detecting light reflected from the surface, and an analytical unit. The light sources and the detector are mutually positioned in this way. The intensity of the reflected light of the mirror in the case of positioning the test Element in accordance with the intended use in the detector is different from the light intensity in the event of an error. The positioning and analytical unit based on the light intensity in the detector detects possible, incorrect positioning.

[0012] The object of the present invention is to provide a method for analyzing a sample on a test element in an analytical system and an analytical system for analyzing trial on an analytical test element that avoids the disadvantages of the prior art. In particular, in the case of the method according to the invention and the analytical system according to the invention, incorrect positioning of the analysis area of ​​the test element in the Z direction should be detected. Done, the spoofing system according to the invention and the analytical system according to the invention should react bovine effectively to the manner in which the elemental test is tested from zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu zu . analytical system.

[0013] Tasks according to the invention, through the method according to claim 1, regarding try analysis on the element test system elemental analysis, elemental control do jednostki analitycznej w pozycji analysis. Controlling obejmuje etapy:

· Na illuminating the light analysis area from at least one analyzing light sources and one control light source

Prev Next, The Light Transmitting Area located between the detector's Test Element is limited by a limiting element that has a Light Transmitting Area, the limiting element being in this manner positioned relative to the analyzing Light Source, control Light Source and detector in the Elementum analysis area test, located in the wrong position of the Z row, in the element retaining the test element, scattered light or

The detector for reflected basically hits the light transmitting area and does not reach. Detector detection signals from the morning signal with a set limit value, however, when the limit value is exceeded, an incorrect position in the Z direction is detected.

At the same time, the element that fixes the element of the test analytical system is the same element that during the analysis on the test element, takes over the test element and serves as a holder. The analytical unit is a component of the analytical system that is used to analyze the test element in the element retaining the test element, in particular the optical measurement system by which the subsequent analysis takes place.

The procedure according to the invention is carried out by means of a test element, which is to be analyzed in a test element retainer. The test element, for this purpose can be manually or automatically positioned in the element fixing the test element relative to the analytical unit. According to the invention, a control is carried out whether the analysis area of ​​the test element is positioned in the position of analysis in the element determining the test element relative to the analytical unit. At the same time, the position analyzey is the same test element posts, in the element retaining the test element, which is intended to perform analysis analysis in the area of ​​the analysis element test. It is therefore the same position of the test element in the test element retainer in which there is no misplacement positioning of the analysis, especially no misplaced positioning of the analysis.

In connection with the present invention, the area of ​​analysis is the same area of ​​the test element in which rehearsal is analyzed. Preferably, this area contains a reagent system that reacts with the analyte in the sample and thereby causes detectable changes. When performing an analysis, the sample is contacted with the analysis area, the sample, for example, being transported by means of a capillary from the application site próbki do obszaru Analysisy.

Controlling, czy obszar analysisy jest pozycjonowany w pozycji analysis, relatywnie do jednostki analitycznej, zgodnie z wynalazkiem, obejmuje etapy:

· Na illuminating the light analysis area from at least one analyzing light sources and one control light source

According to the invention, light sources, with an adherently continuous spectrum emission, yak, for example light bulbs, yak, for example, called so-called lamps. Light emitting diodes are particularly well suited for use in a portable analytical system, because they have a relatively high efficiency factor, which is important in the case of powered instruments. In addition, light emitting diodes are available for the order of wavelength ranges in the visible and infrared region. Preferably, for the present invention, a light source is used that emits a major part of its radiation in the range of wall length, which is strongly absorbed in the area

EP 1 921 441 B1 by analysis, after which the enzymes were reacted on with analytes. For example, laser diodes can be used as a light source. In the case of the present invention, light sources of light one after the other, wherein, between the times when the light source is activated, preferably a shorter period of time occurs. In the case of the present invention, yak detectors preferably use semiconductor elements known in the art, such as photodiodes, phototransistors or photovoltaic elements.

In the case of the present invention, the limiting element limits the light-permeable area through which light scattered by orbital from the anal cast can reach the detector. At the same time, the limiting element is positioned in relation to the control Light source that in the case of an erroneous analysis area Positioning in the Z direction, Light Light sources diffused or reflected from the analysis area, essentially goes to the Elementum Limiting Area that is light permeable. Thanks to topic, the predominant proportion of diffused or reflected light is thus blocked in the light impermeable area that it does not reach the detector. Even in the case of incorrect positioning in the Z direction, the detection signals of the leoni detector are below the set limit value. By comparing the detection signals with at least one predefined limit value, the incorrect position of the analyzing stock in the Z direction can even be detected when the limit value is exceeded.

According to the invention, detection of the light scattered on / or reflected from the cast of the analysis occurs through a detector for receiving detection signals. In connection with the present invention, diffused or reflected light preferably refers to diffused or diffused or regular light. At the same time, the reflection is a reflection of light when it falls on the interface between two centers. Scattering is the deflection of light, caused by small particles, when passing through the center. In the case of diffuse reflection, the rays of the incident light (especially directed) are primarily reflected. They are in many directions. For regular reflection (normal, directed, mirroring), the reflection rule applies. Preferably, in the method according to the invention, the detector detects diffuse light in the analysis area, diffuse light reflected from the analysis area or diffused light in the analysis area and diffused light reflected from the analysis area, particularly preferably, diffused light to control whether the analysis area is positioned in Analysis items.

In the case of the present invention, the yak limiting element serves, for example, for the light-impermeable frame of the optical window existing in the optical analytical system.

Preferably, the method according to the invention is used in the case of analytical systems in which incorrect positioning of the test element leads to falsified Analysis results. To this end, optical measuring systems for photometric analyze test. The method of the invention is used in relatively small analytical systems that can be operated by the patient himself. Such a system is described, for example, in EP-B 0 618 443. The invention is of particular importance for systems in which test axes are used, which can be bent along the longitudinal axis and which are attached with an analytical bench only with

In one end or at both ends, for example, a pin engaging in the recess and optionally a presser adjacent to the outer surface of the test element.

In the present invention, due to the use of Elementum limiting in a favorable manner, a significant reduction in the intensity of the light scattered on or reflected from the analysis area of ​​the Testum element, incorrectly positioned in the Z direction, is achieved. With the distinction between incorrect positioning based on the received detection signals can be detected with high certainty.

In addition, the invention relates to an analytical system according to claim 8 for try analysis on a test analytical element with an analytical unit, wherein the analyte test element is positioned in the analytical position. The analytical system has a control unit for performing control whether the Test Elementum Analysis Area is positioned in the retainer in the analysis position relative to the Analytical Unit, wherein the Control Unit includes at least one analytical Light Sources and one control Light Sources for irradiating the light of the analysis area. a detector for detecting light scattered on or reflected from the cast of analysis for receiving detection signals and an analytical unit. Between the test element located in the retainer and the detector there is a limiting element which has a light impermeable area. The limiting element is positioned in such a way in relation to the light sources that the light of the control light source, scattered or reflected from the analysis area of ​​the test elementum, located in the wrong position in the Z direction in the retainer, goes essentially into the light impermeable area and not reaches the detector. The analytical unit comprises a comparison unit which, by comparing the detection signals with at least one predefined limit value in the event of exceeding the limit value, detects an incorrect position of the analysis area in the Z direction. The analytical system according to the invention can be used in particular for carrying out the method according to the invention. The control unit may correspond to the analytical unit of the analytical system. The control of the detector shall be carried out in the presence of a control over the operation of the detector. In the analytical system of the invention, however, there may also be separate control and analytical units.

According to the invention, in the case of an erroneous position of the Elementum analysis area of ​​the test direction in Z, the detection value is set to the Limit Value, which is the Limit value for the difference of the two luminances of Light sources, namely the analyzing Light sources and the control Light source. The relative Luminance is the ratio of the intensity of the scattered or reflected light from the test Elementum analysis area (especially reflected diffusively) and detected by the detector in the control process, whether the Analysis Area is positioned in the retaining element in the analysis position, to the scattered or reflected light (diffused) by analyzer area of ​​the test element, positioned in the analysisy without trial position (zero value). The zero value is preferably recorded at the beginning of the measurement, before sample application (zero value measurement). If the test element should not be adjusted anymore when measuring the zero value of drilling Z, this is also an error7

No positioning can be detected by the method according to the invention (e.g. in the analytical system according to the invention).

According to a preferred embodiment of the present invention, sample analysis on a test element positioned in the analysis position in the test element retainer comprises the steps of:

· Failure to display the cast of analysis with light from at least one analyzing light source, · Detection of scattered light on orbidden zzyzyz z za za za za za za za za za za za za za za

[0014] The analysis is carried out by the analytical unit of the analytical system according to the invention. This involves photometric analysis, which depends on the intensity of light, light scattered on or reflected from the analysis area (especially diffused or diffusely reflected) by the reaction of the desired analyte in the sample with the reagent contained in the analysis area experiencing a measurable change depending on the concentration analyte in the test. element. Żρθρο 3 ρódτηση απ του προσρια, ódódre j ,,,, waters, kt, kt ,,,,,,,,,, kt, kt, kt ,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, , est, est,, estestestestestestestestestestestestestestestestestest pr pr prest prest pr pr pr pr pr pr pr pr pr pr pr pr The detection signals result from scattered or reflected radiation (diffusively) from the stocking analysis, which through the light-permeable area of ​​the element limiting the projection of the vertigo behind the tide.

[0015] Preferably, for process control whether the analyst area of ​​the test element is positioned in the position of analysis and the same detector is used for the analytical test.

[0016] According to a preferred embodiment of the present invention, the analysis of the trial comprises the steps of:

(a) a control whether the analysis area of ​​the test element is positioned in the analysis position,

(b) contacting the sample with the analysis area to obtain a photometrically detectable change in the Analysis area,

(c) Acting on the basis of the analysis of the characteristics of the aforementioned analysis.

(d) an analysis of the drug drug light sources analysis of a drug substance,

e) comparing the first and second analytical signals through an analytical unit to obtain comparative results and select, based on comparative results, the first

EP 1 921 441 B1 lubricant anabolic analgesics for reorganization of analyte analysis using an analytical method.

[0017] The step there preferably includes one further stage:

a0) insertion of the test element into the element retaining the test element, which can be carried out manually or automatically before stage a).

[0018] The diarrhea in the stages in this procedure is not established in this order. Stage a), for example, may happen later. Unfortunately, the stage there can be carried out many times. Step b) may be followed by rovní przedé stage a0) or ahead of stage a).

[0019] Two zones irradiated by two analyzing light sources may be located overlapping or may be separated from each other. For example, zones of the Analysis area lying next to each other in the Y-row, illuminated by light sources. People ,,,, w ź wwww dow dow, w, w ,,, w, ww, w ,,,,,,,,,,,,,,,,,,,,,,,,

[0020] For example, an analytical signal is selected for analysis that has been more strongly attenuated by a photometrically detectable change in the Analysis area. There is a procedure used to ensure that the analyzey result is obtained from signals that come from the zone completely within the Analysis area. This procedure is described, for example, in WO 00/19185 A1, to which the present invention expressly refers.

[0021] According to a preferred embodiment of the present invention, the method according to the invention comprises the steps of:

i) applying the sample to the application site of probes Elementum test ii) activating at least one analyzing light source for irradiating the first area of ​​the partial analysis area and detecting with a detector, scattered or reflected light by the Analysis area to obtain the first detection signal iii) - the analysis of the narcotics of the narcotics of the narcotics, preferably it is more distant from the application site probes than the first Partial area and detection by means of a detector, scattered or reflected light by the Analysis Area to obtain a second detection signal iv) comparison by the Analytical Unit of the detected Difference value Drug detection signal minus the first detection signal with the set one, the first value of the difference to detect too low a rehearsal dose in the event of exceeding the set first value of the difference.

[0022] Steps iii) and ii) can also be carried out in reverse order. Such a procedure for detecting an underdose is for example described in EP 0819 943 A2, to which the present invention is expressly referred to. For the first and second

Partial obsession refers to partial areas of the stocking analysis, separated from each other or at least not completely overlapping.

[0023] The test is performed on the spastic spreads in the area of ​​analysis, the first of the partial area analysis, and then the second of the area partial analysis. If the dose is too low, try does not reach the second partial, or only partially, so that the value of the difference results: the second detection signal zzyzzyzzyzzyzzyzzyzzyzzyzzyzzyzzyzzyzzyzzyzz, This is because in the second partial area, the scattering or reflection capability of the try is not reduced, as is the case in the first partial area. If too little trial is applied to the test element, this leads to a strong falsification of the results of analysis, because in the case of analysis it was always assumed that the area of ​​analysis is sufficient.

[0024] The procedure according to the invention comprises the steps of:

i) applying the sample to the application site of probes Elementum test ii) activating at least one analyzing light source for irradiating the first area of ​​the partial analysis area and detecting with a detector, scattered or reflected light by the Analysis area to obtain the first detection signal iii) - the analysis of the drug observer partial area partial area, preferably it is more distant from the application site probes than the first Partial area and detection by means of a detector, scattered or reflected light by the Analysis Area to obtain a second detection signal iv) comparison by the Analytical Unit of the detected Difference value Drug detection signal minus the first detection signal with the set one, drug difference value for detecting an incorrect position of the analysis stock in the test element retainer, in the Z direction.

[0025] Steps iii) and ii) can also be carried out in reverse order. In the case of this procedure, which can be carried out alone or in conjunction with the low dose control described above, the first and second detection signals in the form of higher snakes snakes snakes snakes snakes snakes. The path incorrect position, in the case of exceeding the set second difference is detected from the difference value: second detection signal minus first detection signal. At the same time, the limiting element is positioned in this manner with the Z Light of the control light source, scattered on or reflected from the analysis area, located in the wrong position in the Z direction, essentially hits the impermeable to light Elementum area limiting the Light analyzing light sources, scattered on or reflected from of the analysis area, located in the wrong position, row Z generally goes to the light-permeable area of ​​the limiting element. Thanks to the incorrect positioning of the analyza cast, the test element in the Z direction, the light light scattered on or reflected from the analyzing cast, is blocking through the impassable area. In contrast, the light analysis sources of light, scattered on or reflected from the analysis area, despite incorrect positioning in Kie10

In EP 1 921 441 B1, the detector of trunk Z, goes to the light-permeable area of ​​the restricting element and through there reaches to. From this results that the second detection signal weakens, while the first detection signal remains almost unchanged, so that the second setpoint value of the difference Drug detection signal minus the first detection signal is not exceeded by the detected value of the difference on the basis of which an incorrect position can be detected Analysis towards Z. The advantage of this invention is that analyzing and controlling light sources, already existing possibly for detecting too low dose DOS and detector detection signals, resulting from irradiating two partial areas with these light sources, can be used not only to control too low dose but also to control Positions of the cast analysisy of the Z row. Therefore, only the corresponding SOFTWARE is required. Comparative Unit Analytical Unit, so that the difference of detection signals is compared with the set difference Drug value (additional or alternatively to compare the difference of detection signals with the set first difference value).

[0026] In the present invention, the at least one analyzing light source and the controlne light source are preferably activated sequentially. Further, the control light source can be used to detect the presence of tests, for which purpose it is possible to activate the control light to expose the light from zziezwezzia. As soon as in this way, the presence of tests has been detected in the area of ​​analyzes, in the case of the analysis system used, various measurements can be automatically initiated, for example, controls, to settle.

[0027] According to a preferred embodiment of the present invention, the method of proceeding according to the invention comprises one or more of the following stages:

First Measurement of zero value (detection of light of the first, analyzing light source, second, analyzing light source / light source, scattered on orzyzyzzyzzyzzyzzyzzie).

Second Detection of wetting (detection of a change in the light of a control light source, scattered or reflected by extensive analysis).

Third Waiting time (waiting for a certain period of time to ensure that the sample is distributed in the analysis area after detecting the presence of rehearsal).

4th Kinetics measurement (detection of the light of the first, analyzing light source, and / or of the second, analyzing light source, scattered or beaten by the analysis area, during the reactioni zi zi zi zi.

5th Possible selection of analytical signals of one of the first or second, analyzing the source of light (analytical signals that result from the light of selected, analyzing light sources, scattered on or reflected from the analysis area, SA designated for sample analysis, especially for detecting the concentration of the analyte contained in the sample ).

6th Too low dose controls (by comparing the first and second detection signals that result from diffused or reflected light analyzing the light source or con

Of a light source, when the set value of the first differential value is exceeded: the second minus the first detection signal, too low a dose of the sample is detected).

7th Control of positioning the Test Elementum analysis area in the Z direction in the Elementum test element retainer (comparison of the first and second detection signals that result from diffuse or reflected analyzing light Light sources, or control Light source with Drug difference value for detecting the incorrect position of the analysis area in the direction Z, if the set value is exceeded, the second value of the factor).

[0028] The opioid phases of the synovial ganglia made procedure can be changed in this case. For example, Stage 7 positioning control can be carried out after Stage 1 zero value measurement, after Stage 2 wetting detection, after Stage 3 waiting, after Stage 5 low dose control, or after several stages.

[0029] The reaction of measuring kinetics is to be able to detect when the analytes contained in the try contained in the analysis area is completed. Jacket interruption crysterium is defined for sufficient stability of the detective detector value.

[0030] The invention further relates to an analytical system comprising analyzing light sources for irradiating the first partial area of ​​the Testum element in the retainer of the Elementum test, control light sources for irradiating the second part area of ​​the Testum, wherein preferably the Drug Partial area is farther away 2 and at least one detector for detecting analyzing light. Light sources, scattered or reflected by the analysis area and control. Light sources for obtaining the first, relative second detection signal, wherein the limiting element is positioned in this way Ze in the analysis area located in the wrong position of the Z row , control light source light, diffused on or reflected from the Analysis area, essentially hits the light-impermeable Elementum Area limiting the Light analyzing Light sources, scattered on or reflected from the analysis area, located in the wrong position in the Z direction, essentially goes to the light-permeable Elementum Limiting Area, where the Analytical Unit contains a comparison unit, which when the setpoint value is exceeded by detecting the value of the factor: the second detection signal minus the first detection signal detects the incorrect position of the analysisa cast of Z in the test element retainer. Appropriate Elementum constraining arrangement is achieved by fine-tuning the boundary line between the Permeable Area, the Light Area and for the impermeable light, inter alia, to the distance of the irradiated partial areas of the analysis area and to the maximum possible incorrect positioning in the Z direction.

[0031] If you want to post, the system will be populated, the system will be updated, the system elements will be tested, the system elements will be tested, so that the user can remove the incorrect positioning.

The invention is further explained below based on the drawing.

Shown at:

FIG. 1 a test element for use in the method of the invention or the analytical system according to the invention, FIG. 2A, the analytical system with the analysis area positioned in the analyzer position, FIG. 2B, the analytical system according to FIG. 2A with the incorrectly positioned area analysis of a test element, Fig. 3 graph of the value of the difference in relative light remission and control light source and Fig. 4 schematically, the arrangement of the limiting element in the case of the method according to the invention and the analytical system according to the invention.

[0034] FIG. 1 shows a Test strip element that can be used in the method of the invention or in the analytical system of the invention.

Test element 1 contains the analysis area 2, which is used to analyze rehab. Further, test element 1 includes a recess 3 with which the analytical system spigot can engage to position and fix test element 1 in the X and helix Y in the analytical system retainer.

[0036] In the area of ​​analysis 2 of test elements 1 wrestling is the first zone 4, which is illuminated by the first analysis analyzing light source (LED 1A). In addition, in the analyzes area, the second zone 5 is marked, which is illuminated by the light of the second, Light Source Analyzer (LED 1B). this first strfe 4 and strfe strfe 5 contextual side by side drilling y test element 1. The first strfe 4 or cran strfe 5 illustrate the first partial area 6 obschar analysis. Further, the second partial area 7 of the analysis area 2 is illuminated by a control light source (LED 2). The second sub-area 7 is further away from the trial application site 8 than the first sub-site 6. After applying the trial to the trial application site 8, it is transported to the analysis site 2, preferably. Therefore, tryout first reaches the first partial area 6 of the analysis area, which is formed by first strike 4 or drug strike 5. Later, tryout reaches the second partial area 7, which is exposed. As soon as the sample reaches the second Partial Area 7, its scattering or reflecting ability changes, so that when the second Source Area's Partial Light 7 is illuminated, a change in the intensity of the light, scattered or reflected by the second Partial Area 7, is detected, so that the presence of the drug drug partial area 7, and thus in the analysisy area 2, can be detected based on the change of the detection signal.

[0037] The cellular data analysis 2, the elemental test 1w the circuitry the elemental analysis of the system, the active element of the test system, the analysis of the state of the art 4) 6 obserie analysis 2i light scattered or reflected by the area analysisy 2 is detected with a detector to get the first detection signal. ¬ kontrolódjj jestestestestestestestestestest jestestestestestestestestestestestestestestestest act to to to to to to to to to to to to to to to to to to to to to to doektorektorektorektorektorektorektorektor eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee poment eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeeee eeeeeeeeee Pierw13

The second and second detection signals are compared, wherein the difference value is detected: the second detection signal minus the first detection signal. This occurs in the analytical unit of the analytical system. If the setpoint value of the second difference is exceeded, the incorrect value of the Analysis 2 area is detected through this detected difference value (perpendicular to the drawing plane). This is followed by Stadel, that the limiting element is positioned in this way that the Light of the Control Light Source, scattered on or reflected from the analysis area, located in the wrong position in the Z direction, essentially goes to the light-impermeable Elementum Area limiting the Light analyzing Light Sources, scattered on or reflected from the analysis area located in the wrong position in the Z direction, basically hits the light-permeable area of ​​the bounding element. Therefore, the Control Light Light Scattered or Reflected in the Drug Partial Area 7 through the light impermeable Restriction Elementum Area is isolated from the detector of the analyzing light. Light Sources scattered or reflected in the first Analysis Area 6 through the light transmitting Elementum Restricted Area is scattered or reflected (preferably diffusively) reflected in the helium detector. This creates a strongly reduced, second detection signal and largely of a constant value, the first detection signal, so that the difference value: the second detection signal is low for too for too for. Thus, by this comparison, an incorrect position of the analysis area 2 of the test element 1 in the Z direction is detected.

On the other hand, if the first limit value is exceeded through the difference: the second detection signal minus the first detection signal can be detected too neck.

[0039] FIG. 2A is a system analysis analysis element for test 1, positioned in the analysis position.

[0040] The analytical system 9 has an analytical unit 10, which includes a light source 11 and a detector 12. To the retainer 13 the test element is in this test element 1 that through the plug 23 junk position which plug engages with the recess 3 element test 1. In Fig. 2, test element 1 is in the analysis position. In the milk position, the test element 1, especially its analysisy area 2 is positioned correctly in the Z direction relative to the analytical unit 10. The light of the light source 11, through the light transmitting light. In this case, the light-permeable area 14 is a window which is framed by the light-impermeable area 16 of the restraining element. Light The light source 11 is scattered on or reflected from the analysis area 2 of the Testum Elementum 1 and goes back through the light-permeable Area 14 of the Elementum limiting 15 and at least part of the scattered or (preferably diffusively) reflected light, then hits the detector 12 to produce a detection signal .

The analytical system shown in Fig. 2B comprises the same components as the analytical system shown in Fig. 2A, which are marked with references only.

[0042] Due to the force F, test element 1, however, bent, so that there is an incorrect positioning of the analysis area 2 w., Zz Thanks to the subject, the light emitted by the source

Lights 11 and passing through the light-permeable Area 14 of the Restriction Elementum 15 are diffused or (preferably diffusively) reflected from the analysis area 2, however due to the light-impermeable Area 1 of the Restriction Elementum 15 the diffused or reflected light cannot reach detector 12 anymore. Za začení začení začení 12 shows that the limit has been reached, so that incorrect positioning of the analysis Z area can be detected.

[0043] FIG. 3 Shows a graph of the difference value: second detection signal minus the first detection signal, which is detected by irradiation of the second area of ​​the partial stocking analysis, so that

[0044] At thym, the nanoscale Y of the nanoscale is a remnant of the nanoscale, the nanoscale of the nanoscale J is a numeric measurement. Zom measurements presented without try (zero value measurements) with bent test next and measurements from try. Measurements 1 to 6 show the difference in relative remissions ^ rR = rR (LED 2) - rR (LED 1) = rR (controlling the light source), rR (analyzing the light source), which in the case of the test element, without rehab (zero value measurements) . At the same time, it can be detected that the relative remission of led 2 is slightly smaller than the relative remission of led 1, so that the difference of relative remissions is about - 0.12. This difference results, among others, from different optical reasons and different light lengths of both light sources.

[0045] In the case of bending of the test strip (measurements 7 to 9 and 11 to 12), the relative LED remission 2 is strongly reduced because its radiation scattered on or reflected from obstructing it by blocking in by the element. The bending of the test strip, however, has almost no effect on the relative remission of LED 1. Therefore, the relative remission difference decreases strongly to a value of 0.6. Incorrect positioning of the analysis area of ​​this Z test element can be detected when this relative remission difference is compared, for example, with rozní známené znízné znězné znězné zníznego.

[0046] In the case of measurement 10, follow-up test results, a bent silent that it bypassed the mechanical fixation in the analytical system, implemented through the spigot and the analytical system by means of a connecting bore connected to it.

[0047] In measurements 13 to 17, the area of ​​the analytical test element contained try, which affected the difference in relative remissions depending on the concentration of the analyte it contained. Due to the dependence on concentration, the difference in relative remissions is from - 0.17. Belt value [0048] FIG. 4 shows the arrangement of the constraining element in the analytical system of the invention.

At the same time, the analytical system contains a control light source 17 and an analyzing source 18 light filters, through lens 19 and a light-permeable area 14 element

First The shutter 20 is positioned between both light sources 17, 18 so that the UNICKNOWLEDGMENT directly irradiates the detector 12 with the light rays 17, 18. In the case of,

EP 1 921 441 B1 obscure analysis 21, correctly positioned in the element determining the element of the test analytical system, the light of the light of the light, the light is transferred to the second part 7 of the area 2 of the analysis area 2, the analysis is also dispersed and (preferably) the diffusion is also taken. Therefore, the difference of the resulting detection signals lies above the given second difference value. In the case of the test element, in the area of ​​analysis in the wrong position of the Z 22 row, the light of the light emitter 18 goes to the first partial area 6, here it is scattered or (preferably diffusions). The light of the light source control 17 goes to the second Part 7 of the analysis area in the wrong position 22 is here scattered or (preferably diffusively) reflected and does not, however, reach the detector 12 because it prevents light impermeable Area 16 Elementum limiting 15 Therefore, the difference of the two signals detection is below the second setpoint value, so that incorrect positioning of the Analysis 22 area is detected.

List of markers [0050] Test element Analysis area first selection Second zone First zone Partial second area Partial area Sample application analytical system Analytical unit / Control unit Light sources detector Elementum tester Test element Light-permeable area Limiting element Light-permeable area Light source light source lens aperture correctly positioned area Analyze in incorrect spigot position

EP 1 921 441 B1