JP2006250787A - Chromatography measuring device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method for precisely measuring the concentration of an object to be measured in a test solution without any erroneous measurement by a prozone phenomenon from a chromatography specimen having a plurality of reagent immobilization sections. <P>SOLUTION: Light beams 109 are applied to a range including a plurality of reagent immobilization sections 115a-115c of a chromatography specimen 108. An absorbance value at the reagent immobilization sections 115a-115c is detected to the amount of changes in an optical signal obtained in the irradiation range. The presence or absence of the prozone phenomenon is detected from the difference of a plurality of detected absorbance values. At the reagent immobilization section at which no prozone phenomena occur, the concentration of the object to be measured in the test solution is obtained. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a chromatographic measurement apparatus using a chromatographic test piece provided with a plurality of reagent immobilization parts, and more specifically, it is possible to perform highly accurate concentration measurement even when a prozone phenomenon occurs. It is related to technology.

  In recent years, with the improvement of home medical care and regional medical care such as clinics and clinics, as well as the increase in early diagnosis and urgent clinical tests, even non-clinical specialists can easily and quickly achieve high accuracy. A measurement apparatus capable of performing measurement is demanded, and a measurement apparatus for POCT (Point of Care Testing) is in the spotlight.

  POCT is a general term for examinations that are generally performed in “close to the patient” such as practitioners, specialists' examination rooms, wards, and clinics for outpatients. It is attracting attention as it greatly helps to improve the quality of medical care by providing treatment and monitoring the treatment process and prognosis. Compared with the inspection in the central laboratory, it is said that the cost for transporting and installing the specimen and the cost for unnecessary inspection can be suppressed, and the total inspection cost can be reduced.

  The POCT market is rapidly expanding in the United States, where hospital management rationalization is progressing, and is expected to become a growing market worldwide, including Japan. In addition, the basic principle used in POCT is scalable to handle a wide range of objects to be measured, and is developing not only in the clinical field but also in various fields such as the food hygiene related field and the environmental measurement field.

  As a general technique for POCT, a chromatography test piece including a reagent part immobilized on a part of a developing layer for developing a test solution and a labeled reagent part that can be eluted by developing a test solution is used to fix the reagent. There is a chromatographic measurement apparatus for qualitatively or quantitatively measuring a measurement component in a solution to be tested by measuring the binding amount of the labeling reagent in the linking moiety.

  In general, there is a limit to the amount of labeling reagent to be bound in the reagent immobilization part, and in the case of an antigen-antibody reaction, the region where the amount of binding usually increases linearly is about 1 to 2 digits. Even when there are more antigens to be measured, a certain amount of binding saturates, no more antigens can bind, and when the antigens to be measured further increase, a prozone phenomenon occurs. A major problem of the prozone phenomenon is that, despite the fact that the measurement object in the actual solution to be measured has a high concentration, it is possible to obtain an apparently low concentration result. For example, in the case of measurement in a clinical test, the prescription for the patient is selected according to the test result, and in extreme cases, it may be related to the survival of life. It can be the most deadly issue for a company.

  Therefore, if the antigen to be measured is high, it was necessary to dilute in advance. Naturally, in order to carry out dilution and carry out highly accurate quantification, dilution accuracy is also required, and skilled dilution operations are required. The dilution procedure is usually very complicated for inexperienced people with little experience in chemical experiments. Since such a dilution operation takes time and effort, it is not suitable when quick measurement in POCT is required.

  In order to solve these problems, instead of providing only one reagent-immobilized portion on the chromatographic test piece, a plurality of reagent-immobilized portions are provided, and each of the plurality of reagent-immobilized portions is further Chromatographic test strips have been proposed, characterized by having different sensitivities to the concentration of the measurement object by making the affinity for the measurement object in the test solution or the labeling reagent different from each other. (For example, refer to Patent Document 1).

  By providing multiple reagent immobilization units, the amount of labeling reagent binding in the reagent immobilization unit increases, eliminating the need for dilution operations that occur due to the limitations of the amount of binding, and measuring a wide concentration range without dilution operations. It is possible.

The chromatographic measurement apparatus using such a chromatographic test piece extracts and extracts the binding amount in a plurality of reagent immobilization parts from the measurement light obtained by irradiating the test piece while scanning the light source. The presence or absence of the prozone phenomenon and the concentration of the measurement object are detected using the binding amount.
International Publication No. 03/014740 Pamphlet

  As described above, in the conventional chromatographic measurement apparatus, a plurality of reagent immobilization parts having different sensitivities to the measurement target in the solution to be inspected, that is, affinity to the measurement target or binding force, are used as the chromatographic test piece. In addition, not only the concentration of the measurement object but also the prozone phenomenon can be detected from the coloration degree of each reagent immobilization unit.

  In the present invention, as described above, in the measurement apparatus using the chromatographic test piece having a plurality of reagent immobilization units, a more specific and efficient measurement algorithm is proposed, and the measurement accuracy is further improved. Or suggest technology.

  In order to solve the conventional problems, the chromatography measuring apparatus according to the present invention includes a solution to be tested on a chromatography test piece having at least three or more reagent-immobilized portions arranged at intervals on a developing layer. And an object to be measured in the solution to be inspected based on an optical signal obtained by detecting transmitted light or reflected light from the chromatography test piece obtained by irradiating the chromatography test piece with light. In the chromatographic measurement apparatus for determining the concentration of an object, a first index value corresponding to the concentration of the object to be measured in the solution to be inspected from the optical signal detected by one of the plurality of reagent immobilization units. And whether the first index value is within a predetermined reference range, and if it is within the reference range, a measurement pair is determined from the calculated first index value. If the concentration of the object to be measured is not within the reference range, the concentration of the measurement object in any of the remaining reagent immobilization units among the remaining reagent immobilization units is determined based on the magnitude relationship between the first index value and the value of the reference range. It is characterized in that it is selected whether to obtain an index value according to the above.

  The chromatographic measurement apparatus of the present invention develops a solution to be tested on a chromatographic test piece having at least three or more reagent-immobilized portions arranged at intervals on a developing layer, and the chromatography Chromatographic measurement for determining the concentration of the measurement object in the solution to be inspected based on an optical signal obtained by detecting transmitted light or reflected light from the chromatographic test piece obtained by irradiating the test piece with light. In the apparatus, each index value corresponding to the concentration of the measurement object in the test solution is obtained from the optical signal detected by each of the reagent immobilization units, and each index value is predetermined for each reagent immobilization unit. Whether it is within the reference range is detected, and the index value within the reference range is used to output the measurement object concentration. It is an.

  According to the chromatographic measurement apparatus of the present invention, when measurement is performed using a chromatographic test piece provided with a plurality of reagent immobilization units, concentration measurement can be performed more efficiently and with high accuracy.

  Embodiments of a chromatography measuring apparatus according to the present invention will be described below in detail with reference to the drawings.

(Embodiment 1)
FIG. 1 is a diagram showing a schematic configuration of a chromatography measuring apparatus according to the present invention. In FIG. 1, (a) shows the configuration of the apparatus, and (b) shows the configuration of the chromatographic test piece.

  In FIG. 1B, when the test solution is spotted on the spotted portion 112 of the test solution of the chromatography test piece 108, the test solution is developed on the development layer 113 of the chromatography test piece 108. In the unfolding direction, the spot 112 is the upstream side, and the right end side is the downstream side in the figure.

  While the solution to be inspected develops the development layer 113, the labeling reagent develops the development layer 113 together with the solution to be inspected by first passing through the labeling reagent holding unit 114. The labeling reagent binds to the measurement object in the solution to be inspected. The measurement object combined with the developed labeling reagent is fixed to a plurality of reagent fixing parts 115 a to 115 c in the middle of the developing layer 113. Since each reagent immobilization unit has different sensitivity to the measurement object, that is, affinity or binding force to the measurement object, the amount of fixation varies depending on the concentration of the measurement object. Further, the portion of the development layer 113 excluding the labeling reagent holding unit 114 and the reagent immobilization units 115a to 115c is a fabric portion 116.

  In FIG. 1A, light emitted from the semiconductor laser 101 as measurement light is converted into a parallel beam by passing through a collimator lens 102. The parallel beam is incident on the beam splitter 104 after passing through the opening 103. At this time, a part of the light beam reflected by the beam splitter 104 is received by the first photodiode 106 as the reference light 105. On the other hand, the remaining parallel beams that have passed through the beam splitter 104 are condensed only in the long side direction of the chromatographic test piece 108 by the cylindrical lens 7 and irradiated onto the chromatographic test piece 108 as an elliptical beam 109. At this time, reflected light 110 is generated from the surface of the chromatographic test piece 8 and is received by the second photodiode 111. In addition, it is good also as a structure which does not receive the scattered light 110 from the surface of the chromatography test piece 108, but permeate | transmits the transmitted light which permeate | transmitted the chromatography test piece 108 with a photodiode.

  Next, the optical signal detection unit 119 performs log conversion on the outputs received by the first photodiode 106 and the second photodiode 111 by the log conversion function units 117 and 118, respectively, and the values converted by the log conversion function unit 117. Is subtracted from the value converted by the Log conversion function unit 118 and output as an absorbance value. If nothing is described thereafter, the absorbance indicates the optical signal, and the absorbance value indicates the value of the optical signal.

  Next, FIG. 2 is a diagram showing a relationship between a chromatographic test piece and an absorbance waveform obtained by scanning the chromatographic test piece.

  The absorbance waveform 201 shown in FIG. 2 is obtained by moving the light beam on the chromatographic test piece 108 in parallel with the development direction of the test solution after the test solution spotted on the chromatographic test piece 108 is completely developed. FIG. 5 is a set waveform of absorbance values 203a to 203d that are irradiated in a predetermined measurement range 202 including a plurality of reagent immobilization parts of the chromatographic test piece 108 and sampled at a constant period (period is distance or time). At this time, the chromatographic test piece 108 may be moved with respect to the light beam instead of moving the light beam.

  Next, an index detection unit that detects an index value corresponding to the measurement object in the solution to be tested in each reagent immobilization unit from the detected absorbance will be described with reference to FIGS.

  FIG. 3 is a diagram showing the absorbance value in each reagent immobilization section. FIG. 4 is a diagram showing the absorbance values of impure components (impurity components will be described later). FIG. 5 is a diagram illustrating index values corresponding to the measurement target of the solution to be tested in the reagent immobilization unit.

  In FIG. 3, from the absorbance waveform 201 in the measurement range 202 of the chromatographic test piece 108, the maximum value of the absorbance waveform 201 in the ranges 301, 302, and 303 corresponding to the three reagent immobilization units 115a to 115c (the first value) 1), and the detected value is set as an absorbance value An corresponding to each reagent immobilization unit 115a to 115c. N of An indicates the number of reagent immobilization parts, and indicates all of the absorbance value A1, the absorbance value A2, and the absorbance value A3 (hereinafter, n also has the same meaning). The absorbance value An at this time is an absorbance value including the influence of an impure component such as an unnecessary labeling reagent or a residue of the test solution itself, in addition to the measurement target of the test solution. Therefore, in order to extract only the component of the measurement object of the solution to be inspected, it is necessary to detect the absorbance value of the impure component from the absorbance value An.

  Therefore, in FIG. 4, the absorbance value Bn (absorbance value B1, absorbance value B2, and absorbance value B3) of the impure component is detected.

  First, the detection of the absorbance value B1 is performed on the upstream side of the chromatographic test piece including the range not affected by the reagent immobilization unit 115a, based on the detection position of the absorbance value A1 corresponding to the reagent immobilization unit 115a. In the absorbance waveform 201 corresponding to 401, an absorbance value 405a that is the minimum value (the extreme value opposite to the first extreme value) is detected. Here, the opposite extreme value means the minimum value with respect to the maximum value, and in this example, the absorbance value was set such that the higher the absorbance with respect to the irradiated light beam, the higher the value. That is, if there is a large amount of labeling agent or the like in the reagent immobilization part, the light absorption increases and the value increases. On the contrary, the absorbance value may be set so that the value decreases as the absorbance increases. That is, when the value is set to be low, the minimum value is detected when the absorbance value An is detected from the absorbance waveform, and the maximum value is detected when the absorbance value B1 is detected.

  The absorbance value 405a is a second extreme value corresponding to the reagent immobilization unit 115a. Next, in the absorbance waveform 201 corresponding to the range 402 between the absorbance values A1 and A2 corresponding to the reagent immobilization unit 115a and the reagent immobilization unit 115b, the absorbance value 115b that is the minimum value is detected. The absorbance value 115b is a third extreme value corresponding to the reagent immobilization unit 115a. (This is also the second extreme value corresponding to the reagent immobilization unit 115b.) Finally, the average of the two detected absorbance values 405a and 405b is calculated, and the calculated value is used as the absorbance value B1. .

  Similarly, the detection of the absorbance value B2 is performed by detecting the absorbance value 405c (the minimum value in the absorbance waveform 201 corresponding to the range 403 between the absorbance value A2 and the absorbance value A3 of the reagent immobilization unit 115b and the reagent immobilization unit 115c). The third extremum corresponding to the reagent immobilization unit 115b and the second extremum corresponding to the reagent immobilization unit 115c) are detected, and the average of the detected absorbance value 405b and the absorbance value 405c is calculated. . The calculated value is defined as an absorbance value B2.

  Further, similarly, the detection of the absorbance value B3 is performed on a chromatographic test piece including a range not affected by the reagent immobilization unit 115c, based on the detection location of the absorbance A3 corresponding to the reagent immobilization unit 115c. In the absorbance waveform 201 corresponding to the range 404 on the downstream side, a minimum absorbance value 405d (the third extreme value corresponding to the reagent immobilization unit 115c) is detected, and the detected absorbance value 405c and absorbance value 405d are detected. The average of is calculated. The calculated value is defined as an absorbance value B3.

  The absorbance values 405a to 405d are absorbance values corresponding to the fabric portion. Although the impure component remains in the dough part, unlike the reagent immobilization part, the dough part does not hold the labeling agent of the measurement object. Therefore, the absorbance values 405a to 405d can determine the absorbance value of the impure component. Furthermore, by using the absorbance value Bn that is the average of the absorbance values at the upstream and downstream portions of each reagent immobilization unit, the influence of the impurity component unevenness is reduced.

  In FIG. 5, values obtained by subtracting the absorbance values B1 to B3 corresponding to the reagent immobilization units 115a to 115c from the absorbance values A1 to A3 corresponding to the reagent immobilization units 115a to 115c are obtained. The index values C1 to C3 corresponding to the measurement objects of the solution to be inspected in ˜115c are used.

  As described above, for the index value Cn, the absorbance value An that is the maximum value in each of the reagent immobilization units 115a to 115c is obtained, and other than the reagent immobilization units adjacent to the upstream side and the downstream side of each reagent immobilization unit. In the development layer, the average value of the two detected minimum values is obtained as the absorbance value Bn, and the difference between the absorbance value An and the absorbance value Bn is not required to bind to the measurement object in the test solution. It is possible to remove the influence of impure components due to the residual labeling reagent and the residual liquid of the solution to be inspected, so that highly accurate measurement can be performed.

  Next, detection of the prozone phenomenon will be described with reference to FIGS. FIG. 6 shows the measurement results (three index values) in each reagent immobilization unit obtained when the actual concentration of the measurement object (actual concentration) is changed, and explains the prozone phenomenon. It is.

  In FIG. 6, the index value in each reagent immobilization unit obtained by measurement with respect to the actual concentration is indicated by index waveforms 601a to 601c with respect to the actual concentration of the measurement object in the test solution. Further, in the indicator waveforms 601a to 601c, the prozone phenomenon occurs at 602a to 602c, respectively. However, up to the actual concentration 603, the actual concentration can be obtained using any one of the index waveforms 601a to 601c. Therefore, the prozone phenomenon 602c is detected.

  In FIG. 7, in order to detect the occurrence of the prozone phenomenon after the actual concentration 603, the difference 701 between the index waveform 601c and the index waveform 601a at the actual concentration 603 and the difference between the index values between the index waveform 601c and the index waveform 601b. 702 is detected.

The detected difference is
Difference 701> Threshold 1A and Difference 702> Threshold 1B
If so, it is determined that the prozone phenomenon has occurred.

  The threshold value 1A and the threshold value 1B can be changed for each production lot of the sensor, and are set by checking the property of the production lot of the sensor before shipment. Thereby, it is possible to cope with the difference in properties in the production lot of the sensor. Similarly, the occurrence of the prozone phenomenon can be detected by using the difference between the index values for the other index waveforms.

  As described above, by taking the difference between the two index values and detecting the prozone phenomenon based on the magnitude relationship between the difference and a predetermined threshold value, erroneous measurement due to the prozone phenomenon can be prevented. .

  Next, an algorithm for obtaining the concentration of the measurement object in the solution to be inspected will be described with reference to FIGS. 8 and 9 are diagrams showing the relationship between the index waveform and the quantitative range.

  If the prozone phenomenon has not occurred, it is determined from the index value of each reagent immobilization unit whether the concentration of the measurement object can be quantitatively measured. The range of the quantitative measurement varies depending on the performance and type of the chromatographic test piece, and determines the range in which the chromatographic test piece can be quantitatively measured in the process of the production stage or in the examination stage. In the first embodiment, it is assumed that quantitative measurement can be performed in a range in which the concentration of the measurement object in the solution to be inspected includes a numerical value of 0.1 to 10.0 mg / dL. The conversion from the index value to the concentration of the measurement object is executed by a calibration curve corresponding to each index value. The calibration curve is also determined in the manufacturing process or in the examination stage.

  In FIG. 8, the measurement result (first index value) of the index waveform 801b having good sensitivity to an intermediate density among the three index waveforms is used first. The index value result corresponding to the measured index waveform 801b is selected as the index value for obtaining the concentration of the measurement object in the test solution according to the comparison result with any one of the following reference ranges (1) to (3) To do.

  (1): If the first index value is in the range of 1.0 to 2.0 mg / dL, the concentration is displayed as it is.

  (2): If the first index value is less than 1.0 mg / dL, the measurement result of the index waveform 801a having good sensitivity to low concentration is used. Further, if the result of the index value corresponding to the measured index waveform 801a is within the range of 0.1 to 1.0 mg / dL, the concentration is displayed. At this time, if it is less than 0.1 mg / dL, it is out of the quantification range. Moreover, if it is in the range exceeding 1.0 mg / dL, an error is determined that there is a possibility of erroneous measurement.

  (3): If the first index value exceeds 2.0 mg / dL, the measurement result of the index waveform 801c having good sensitivity to high concentration is used. Further, if the result of the index value corresponding to the measured index waveform 801c is within the range of 2.0 to 10.0 mg / dL, the concentration is displayed. At this time, if it exceeds 10.0 mg / dL, it is out of the quantitative range. Moreover, if it is less than 2.0 mg / dL, it will be considered as an error because there is a possibility of erroneous measurement in the measurement result.

  When the result of (1) further subdivides the comparison range with the first index value and the first index value falls within the range of 1.0 to 1.2 mg / dL, Alternatively, the concentration may be obtained by using both of the measurement results of the indicator waveform having good sensitivity to the concentration. Furthermore, even when there are more than three index values, the actual density can be obtained by sequentially comparing the index values of the sensitivity with respect to the intermediate density.

  In the above example, an indicator waveform with good sensitivity to intermediate concentrations is selected first to determine whether the indicator value is within the reference range. The index value in can be selected first to determine whether it is within the reference range.

  As described above, it is detected whether the first index value detected in one reagent immobilization unit among the plurality of reagent immobilization units is within the predetermined reference range, and the reference range If it is within the range, the concentration of the measurement object is calculated from the obtained first index value. If it is not within the reference range, the remaining reagent immobilization unit is determined based on the magnitude relationship of the reference range with the first index value. By selecting whether to obtain the index value in any reagent immobilization unit, it is possible to select an index value necessary for obtaining the concentration of the measurement object from a plurality of index values.

  Also, instead of using the comparison results (1) to (3) above, in FIG. 9, it is detected whether each of the three measurement results is within the reference range predetermined for each reagent immobilization unit, and within the reference range. It is also possible to obtain the concentration of the measurement object using the index value in Specifically, the result of the index value corresponding to the index waveform 901a is within the range of 0.1 (second threshold Amin) to 1.2 (second threshold Amax) mg / dl, or corresponds to the index waveform 901b. The result of the index value to be within the range of 1.0 (second threshold Bmin) to 2.0 (second threshold Bmax) mg / dl, or the index value corresponding to the index waveform 901c is 1.8 It is determined whether it is within the range of (second threshold value Cmin) to 10.0 (second threshold value Cmax) mg / dl. As a result of the determination, the result of the index value within the range is used for the density display. When there are a plurality of results used for the index value, the plurality of index values can be used, for example, the average value can be used as the result.

  However, when all three or more index values are suitable for determination, or when sensitivity results that are not adjacent to each other are suitable for determination, such as measurement results corresponding to the index waveform 901a and the index waveform 901c, there is a possibility of erroneous measurement. Make an error as there is. Further, when the result of the index value corresponding to the index waveform 901a having the highest sensitivity to the low concentration is less than 0.1 mg / dl, the result of the index value corresponding to the index waveform 901c having the highest sensitivity to the highest sensitivity is obtained. If it exceeds 10.0 mg / dl, it is out of the quantitative range.

  In addition, if a quantitative measurement is not possible, if a prozone phenomenon occurs or if the measurement is out of the quantitative range, a liquid crystal display that can display the measurement results other than the numerical value, and a measurement result lower than the quantitative range. Qualitative display is performed by displaying LOW when the prozone phenomenon occurs or when the measurement result is higher than the quantitative range. The qualitative display may be indicated by a change in buzzer sound period, generation time, or volume.

  The chromatographic measurement apparatus according to the present invention is useful in a field where it is necessary to avoid erroneous measurement due to the prozone phenomenon when there are a plurality of optical signals corresponding to the measurement object.

  Furthermore, it has a function of reducing the influence of impure components that become noise, and thus is useful in fields that require high-accuracy measurement.

Schematic configuration diagram of a chromatographic measurement apparatus and a test piece in Embodiment 1 of the present invention The figure which shows the relationship between a chromatographic test piece and an absorbance value in the same form The figure which shows the absorbance value in each reagent immobilization part in the same form The figure which shows the light absorbency value of the impure component in the same form The figure which shows the index value corresponding to a measurement object in the same form The figure which shows the relationship between the indicator waveform and the prozone phenomenon in the same form The figure which shows the relationship between an indicator waveform and a prozone phenomenon detection part in the same form The figure which shows the relationship between the indicator waveform and the fixed range in the same form The figure which shows the relationship between the indicator waveform and the fixed range in the same form

Explanation of symbols

DESCRIPTION OF SYMBOLS 101 Semiconductor laser 102 Collimating lens 103 Opening part 104 Beam splitter 105 Reference light 106 1st photodiode 107 Cylindrical lens 108 Chromatography test piece 109 Elliptical beam (light)
DESCRIPTION OF SYMBOLS 110 Scattered light 111 2nd photodiode 112 Spotting part of to-be-tested solution 113 Developing layer 114 Labeling agent holding | maintenance part 115a, 115b, 115c Reagent immobilization part 116 Dough part 117, 118 Log conversion function part 119 Optical signal detection part 201 Absorbance (optical signal) waveform 202 Measurement range 203a, 203b, 203c, 203d Absorbance value 301, 302, 303 Corresponding range of reagent immobilization unit 401, 402, 403, 404 Impurity component absorbance value detection range 405a, 405b, 405c, 405d Minimum absorbance value for reagent immobilization part 601a, 601b, 601c, 801a, 801b, 801c, 901a, 901b, 901c Index waveform 602a, 602b, 602c Prozone phenomenon 701, 702 Difference in index value 603 Actual limit of measurement concentration A1, A2, A3 Absorbance value in reagent immobilization part B1, B2, B3 Absorbance value of impure component in reagent immobilization part C1, C2, C3 Index value of measurement object in reagent immobilization part

Claims (8)

The test solution is developed on a chromatographic test piece having at least three or more reagent-immobilized portions arranged on the development layer with a space therebetween,
Based on an optical signal obtained by detecting transmitted light or reflected light from the chromatographic test piece obtained by irradiating the chromatographic test piece with light, the concentration of the measurement object in the solution to be inspected is obtained. In the chromatographic measurement device,
From the optical signal detected by one reagent immobilization part of the plurality of reagent immobilization parts, to determine a first index value according to the concentration of the measurement object in the solution to be tested,
Detecting whether the first index value is within a predetermined reference range;
If it is within the reference range, the measurement object concentration is calculated from the obtained first index value,
If it is not within the reference range, the index value corresponding to the measurement object concentration in any reagent immobilization unit among the remaining reagent immobilization units is determined from the magnitude relationship between the first index value and the value of the reference range. Chromatography measuring device characterized by selecting whether to obtain. The test solution is developed on a chromatographic test piece having at least three or more reagent-immobilized portions arranged on the development layer with a space therebetween,
Based on an optical signal obtained by detecting transmitted light or reflected light from the chromatographic test piece obtained by irradiating the chromatographic test piece with light, the concentration of the measurement object in the solution to be inspected is obtained. In the chromatographic measurement device,
Obtain each index value according to the concentration of the measurement object in the solution to be inspected from the optical signal detected by each of the reagent immobilization units,
Detect whether each index value is in a reference range predetermined for each reagent immobilization unit,
A chromatographic measurement apparatus characterized in that an index value within the reference range is used to output the concentration of a measurement object. 3. The chromatography measuring apparatus according to claim 2, wherein when there are a plurality of index values in the reference range, the plurality of index values are used for outputting the concentration of the measurement object. The difference between at least two of the index values obtained by each reagent immobilization unit is taken, and whether or not the prozone phenomenon has occurred is detected based on the difference between the difference value and a predetermined threshold value. The chromatography measurement apparatus according to claim 1 or 2, wherein the chromatography measurement apparatus is configured to do so. 5. The chromatography measurement apparatus according to claim 4, wherein the threshold value is changed according to a type of the chromatography test piece. The index value is
Find the first extreme value that is the extreme value in each reagent immobilization unit,
Furthermore, in the development layer other than the reagent immobilization unit adjacent to the upstream side and the downstream side of the reagent immobilization unit, the second extreme value and the third extreme value that are opposite to the first extreme value are obtained. Detecting the average value of the detected second extreme value and the third extreme value,
The chromatography measurement apparatus according to claim 1, wherein a difference between the first extreme value and the average value is used as an index value. The chromatographic measurement apparatus according to claim 6, wherein the second extreme value or the third extreme value is detected from a range between the first extreme value detected by the reagent immobilization units adjacent to each other. 3. The chromatogram according to claim 1 or 2, wherein qualitative output is performed when a prozone phenomenon occurs or when the concentration of the measurement object in the solution to be inspected is in a range where it cannot be quantitatively output. Graphy measuring device.

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