JP2003004743A - Chromatographic quantitative measurement apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a chromatographic measurement apparatus which automatically manages a time up to a measurement and enables an immunochromatographic quantitative analysis with the apparatus operability enhanced. SOLUTION: A system is constructed, in which a light beam 16 irradiated to a chromatography specimen 8 is made to wait in a state in which the light beam is irradiated between a standard reagent hold part 12 and a reagent immobilization part 13, and an absorbance change in accordance with the elution of a standard reagent is detected. The system automatically starts measurements a constant time later from the detection.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a chromatographic quantitative measuring device, and more particularly to a chromatographic quantitative measuring device for performing optical signal detection to measure the concentration of an analyte.

[0002]

2. Description of the Related Art A conventional chromatographic quantitative measuring device will be described below. FIG. 11 is a schematic configuration diagram of a conventional chromatography quantitative measurement device. FIG. 11 (a)
Is a schematic configuration diagram of a measuring device using a spectrophotometer,
FIG. 11B is a configuration diagram of the chromatography test piece.

In FIG. 11A, the light beam 33 emitted from the lamp 1 is incident on the diffraction grating 3 via the reflection plate 2. The light beam 33 incident on the diffraction grating 3 has its light wavelength selected, and the light beam 33 is further narrowed down by the opening 4 and then incident on the glass plate 5. The light beam 33 reflected by the glass plate 5 is received by the first photomultiplier tube 7 as the reference light 6. On the other hand, the light beam 33 transmitted through the glass plate 5 irradiates a part of the chromatography test piece 8 and the scattered light 9 from the chromatography test piece 8 is received by the second photomultiplier tube 10. First photomultiplier tube 7 and second
The output signals of the photomultiplier tubes 10 are Log-converted, respectively, and the Log-converted values of the second photomultiplier tube 10 are subtracted from the Log-converted values of the first photomultiplier tube 7 and output as absorbance signals. .

The chromatographic test piece 8 is shown in FIG.
As shown in (b), the test solution adding section 11 for adding the test solution and the spreading layer 14 for spreading the test solution.
And a reagent immobilization portion 13 formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer 14, and spreading the test solution on another part of the spreading layer 14. It is composed of a labeled reagent holding part 12 formed by holding a labeled reagent that can be eluted by the above, a reagent immobilization part 13 from the spreading layer 14, and a cloth part 15 which is a part excluding the labeled reagent holding part 12. There is.

The operation of the thus-configured chromatography quantitative measuring device will be described with reference to FIG. First, when the test solution is added to the test solution adding section 11, the test solution is spread on the spreading layer 14. At this time, when the test solution reaches the labeled reagent holding section 12, the labeled reagent is eluted and specifically binds to the analyte contained in the test solution. Subsequently, the bound substance is immobilized in the reagent immobilization unit 13, and the remaining unimmobilized labeling reagent flows out to the downstream side of the development layer 14 without being immobilized.

Therefore, in order to measure the concentration of the analyte contained in the solution to be inspected, the reagent immobilization section 13 and the dough section 15 of the chromatographic test piece 8 are analyzed by a spectrophotometer from the absorbance of the dough section 15, The concentration of the analyte can be obtained by subtracting the absorbance of the reagent immobilization unit 13 to detect the absorbance signal and converting from the known calibration curve.

[0007]

However, in the above-mentioned conventional chromatographic quantitative measuring device, in the reagent immobilization section 13 of the chromatographic test piece 8, the test solution slowly develops the developing layer 14, The value of the detection signal gradually changes with time. In other words, in order to obtain more stable measurement results, it is important to manage the measurement time, so there is no time management function in the conventional measurement using a spectrophotometer. In addition, it is necessary for the measurer to manually manage the time, which poses a problem that the measurement work becomes troublesome.

Further, depending on the condition of the solution to be inspected and the chromatographic test piece 8, there may be a test piece that interferes with normal measurement. In the conventional measurement using a spectrophotometer, the test piece is inspected. Since there is no function to detect the state of the solution or the chromatographic test piece 8, the measurer has to manually determine whether the quality is good or bad, and there is a problem that the measurement work becomes troublesome.

Further, since the labeled reagent remains in the labeled reagent holding portion 12 of the chromatography test strip 8 even after elution, it is necessary to reduce the influence of the residual labeled reagent in order to improve the accuracy of quantitative measurement. is there. However, in the measurement using the conventional spectrophotometer, since there is no function to identify the residual labeling reagent, it is necessary for the measurer to manually identify it, and there is a problem that the measurement work becomes troublesome. It was

The present invention has been made in order to solve the above-mentioned problems, and manages the time until the measurement, the quality of the test piece and the correction of the quantitative measurement automatically to improve the operability of the apparatus. It is an object of the present invention to provide a facilitated chromatography quantitative measurement device.

[0011]

In order to solve this problem, the chromatography quantitative measurement device according to claim 1 of the present invention comprises a developing layer for spreading a test solution and a part of the developing layer. A reagent immobilization part formed by immobilizing a reagent for a measurement object in the test solution, and a labeled reagent that can be eluted by the development of the test solution in another part of the spreading layer. A labeling reagent holding part formed by the above, a reagent immobilization part from the spreading layer, and a dough part which is a part excluding the labeling reagent holding part, to a chromatographic test piece, emitted from a light source. Irradiate a light beam, perform optical signal detection using transmitted light or reflected light from the chromatography test piece, and quantitatively determine the concentration of the analyte contained in the test solution from the signal. In the chromatographic quantitative measurement device to be determined, the test solution is added to the chromatographic test piece, and after a certain time after the development of the test solution is detected at any place, the analysis contained in the test solution is performed. It is characterized in that the concentration of the object is measured.

The chromatography quantitative measurement device according to a second aspect of the present invention is the chromatography quantitative measurement device according to the first aspect, wherein the detection of the development of the test solution occurs by the elution of the labeling reagent. The detection is performed by detecting a change in the detection signal.

The chromatography quantitative measurement device according to claim 3 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein a test solution is added to the chromatography test piece, The development of the test solution is detected in a region from the labeled reagent holding section to the reagent immobilization section.

The chromatography quantitative measurement device according to claim 4 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein the temperature,
It is characterized in that at least one of the humidity and the humidity is monitored, and a preset constant time for measuring the concentration of the analyte is corrected.

The chromatographic quantitative measuring device according to claim 5 of the present invention is the chromatographic quantitative measuring device according to claim 1 or 2, wherein the light source of the light source is detected while the development of the test solution is detected. It is characterized by alternately turning on and off.

The chromatography quantitative measurement device according to claim 6 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein the light source detects the development of the test solution. The feature is that it is turned off until just before.

The chromatography quantitative measurement device according to claim 7 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein the output of the light source is detected while the development of the test solution is detected. Is smaller than when the concentration of the analyte is measured.

Further, the chromatography quantitative measuring device according to claim 8 of the present invention comprises a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement device for performing optical signal detection using transmitted light or reflected light of the above and quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal. In, the test solution is added to the chromatography test piece, the development speed after the addition of the test solution is detected, and the quality of the performance of the chromatography test piece is determined from the development speed. Is.

Further, the apparatus for quantitatively measuring chromatography according to a ninth aspect of the present invention is the apparatus for quantitatively measuring chromatography according to the eighth aspect, wherein the developing speed is the rate of developing the test solution on the chromatographic test piece. It is characterized in that the time change of the value of the detection signal generated by the outflow of the labeled reagent due to is detected and calculated.

Further, the chromatography quantitative measuring device according to claim 10 of the present invention is the chromatography quantitative measuring device according to claim 8, wherein the developing speed is the spreading of the test solution on the chromatography test piece. The method is characterized in that the light beam is scanned so that the increase value of the detection signal generated by the elution of the labeled reagent due to is kept constant, and is calculated from the scanning speed of the light beam.

The chromatography quantitative measurement device according to claim 11 of the present invention is the chromatography quantitative measurement device according to claim 8 in which the surrounding environment at the time of developing the test solution onto the chromatography test strip It is characterized in that the discriminant value of the development speed is corrected by judging the quality of the performance of the chromatography test piece from the result of measuring at least one of the temperature and the humidity.

Further, in the chromatographic quantitative measurement device according to the twelfth aspect of the present invention, a developing layer for spreading the test solution and a reagent for a measurement object in the test solution are provided in a part of the spreading layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In location, from said detection signal at the fabric portion of strip the chromatographic test of the inspection target solution, is characterized in that to determine the type of the inspection target solution.

According to a thirteenth aspect of the present invention, there is provided the chromatography quantitative measurement device according to the twelfth aspect, wherein the dough portion for measuring the detection signal is located in the developing direction from the reagent immobilization portion. It is characterized by being on the downstream side.

The chromatography quantitative measurement device according to a fourteenth aspect of the present invention is characterized in that, in the chromatography quantitative measurement device according to the twelfth aspect, a calibration curve suitable for the test solution can be selected in advance. It is a thing.

Further, in the chromatographic quantitative measurement device according to claim 15 of the present invention, a developing layer for spreading the solution to be inspected and a reagent for a measurement object in the solution to be inspected are provided in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the setting, the downstream end of the dough portion on the chromatographic test strip to which the test solution has been added, from the detection signal obtained by irradiating a light beam, the addition amount of the test solution is insufficient, and the chromatographic test It is characterized in that the development failure of one piece is determined.

[0026] The chromatography quantitative measurement device according to a sixteenth aspect of the present invention is the chromatography quantitative measurement device according to the fifteenth aspect, wherein the light beam is
It is characterized by scanning from the upstream end to the downstream end of the cloth portion on the chromatography test piece.

Further, in the chromatographic quantitative measurement device according to claim 17 of the present invention, a developing layer for spreading the solution to be inspected and a reagent for a measurement object in the solution to be inspected are provided in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the arrangement, the detection signal at the reagent immobilization unit, when the detection signal at the position downstream of the reagent immobilization unit in the developing direction and at a position not affected by the reagent immobilization unit is a reference value, It is characterized in that it is used as a detection signal for density measurement.

The chromatography quantitative measurement device according to claim 18 of the present invention is the chromatography quantitative measurement device according to claim 17, wherein the detection signal of the concentration measurement is before and after the extreme value of the reagent immobilization part. The average value of the values, the detection signal to be the reference value, the downstream of the reagent immobilization portion in the developing direction of the solution to be inspected, and the average value of the values before and after the position not affected by the reagent immobilization portion. It is characterized by

Further, in the chromatography quantitative measurement device according to claim 19 of the present invention, in the chromatography quantitative measurement device according to claim 17, the detection signal for the concentration measurement is around the extreme value of the reagent immobilization part. The intermediate value of the value, the detection signal to be the reference value, the intermediate value of the value before and after the position where there is no influence of the reagent immobilization unit downstream of the reagent immobilization unit in the developing direction of the test solution. It is characterized by

The chromatography quantitative measurement device according to a twentieth aspect of the present invention is the chromatography quantitative measurement device according to the seventeenth aspect, in which the values before and after the extreme value of the detection signal in the reagent immobilization section are compared. When the difference exceeds the discriminant value, it is determined that the chromatography test piece has poor performance.

The chromatography quantitative measurement device according to a twenty-first aspect of the present invention is the chromatography quantitative measurement device according to the seventeenth aspect, wherein the reagent immobilization is performed on the downstream side of the reagent immobilization portion in the developing direction. It is characterized in that the values before and after the position where there is no influence of the part are compared, and if the difference exceeds the discriminant value, it is judged that the chromatography test piece has poor performance.

Further, in the chromatographic quantitative measurement device according to a twenty-second aspect of the present invention, a spreading layer for spreading the test solution and a reagent for a measurement object in the test solution are provided in a part of the spreading layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In location, the time of concentration measurement is characterized in making measurements with the exception of labeling reagent holding part on the strip the chromatographic test.

Further, in the chromatography quantitative measuring device according to claim 23 of the present invention, a developing layer for spreading the solution to be inspected and a reagent for a measurement object in the solution to be inspected are provided in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In location, area value of the detection signal is flat on the strip the chromatographic test is characterized in that considered as the region of the labeling reagent retaining part.

The chromatography quantitative measurement device according to a twenty-fourth aspect of the present invention is the chromatography quantitative measurement device according to the twenty-third aspect, in which the width of the region where the value of the detection signal on the chromatography test piece is flat is set. It is characterized in that the width is calculated and the width is compared with the width of the prescribed labeled reagent holding portion.

Further, the chromatography quantitative measuring device according to claim 25 of the present invention is the chromatography quantitative measuring device according to claim 23, wherein a value at which the detection signal on the chromatography test piece becomes flat is detected, The method is characterized by confirming the amount of the residual labeling reagent from the value.

Further, in the chromatographic quantitative measurement device according to claim 26 of the present invention, a developing layer for spreading the solution to be inspected and a reagent for a measurement object in the solution to be inspected are provided in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In location, it recognizes the rising and falling of the detection signal, and wherein the determining the extreme value of the detection signal.

A thirty-seventh aspect of the present invention is a chromatographic quantitative measurement device according to the twenty-sixth aspect of the present invention, wherein the rise and fall of the detection signal are recognized and the rise and the rise of the detection signal are recognized. It is characterized in that the interval between the falling edges is calculated, and the size of the interval is compared with the width of the prescribed reagent immobilization portion.

[0038]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below. (Embodiment 1) Hereinafter, claims 1 to 7 of the present invention
A first embodiment of the invention corresponding to will be described with reference to FIGS. 1 and 2. 1 is a schematic configuration diagram of a chromatography quantitative measurement device according to a first embodiment of the present invention. FIG. 1A is a schematic configuration diagram of a measuring device using a spectrophotometer, and FIG. 1B is a configuration diagram of a chromatography test piece.

In FIG. 1A, the light emitted from the semiconductor laser 17 is converted into a parallel beam by passing through the collimator lens 18. This parallel beam passes through the opening 4 and is incident on the beam splitter 19. Here, a part of the light beam reflected by the beam splitter 19 is received by the first photodiode 20 as the reference light 6. On the other hand, the remaining light beam that has passed through the beam splitter 19 is condensed by the cylindrical lens 21 only in the long side direction of the chromatography test piece 8 and is irradiated onto the chromatography test piece 8 as an elliptical beam 16. Further, scattered light 9 is generated from the surface of the chromatography test piece 8 and is received by the second photodiode 22.

Next, the outputs of the first photodiode 20 which receives the reference light 6 and the output of the second photodiode 22 which receives the scattered light 9 are respectively Log-converted to obtain the Log-converted value of the first photodiode 20. Then, the Log converted value of the second photodiode 22 is subtracted from the output and is output as an absorbance signal.

The chromatographic test piece 8 is shown in FIG.
As shown in FIG. 3, a test solution adding section 11 for adding the test solution, a spreading layer 14 for spreading the test solution, and a reagent for the measurement object in the test solution are provided in a part of the spreading layer 14. Reagent immobilization part 13 formed by immobilization
And a labeling reagent holding part 12 formed by holding a labeling reagent that can be eluted by the development of the test solution on the other part of the development layer 14, and the development layer 14 to the reagent immobilization part 1
3 and the dough portion 15 which is a portion excluding the labeling reagent holding portion 12.

The operation of the thus-configured chromatography quantitative measuring device will be described with reference to FIG. First, when the test solution is added to the test solution adding section 11, the test solution is spread on the spreading layer 14. At this time, when the test solution reaches the labeled reagent holding section 12, the labeled reagent is eluted and specifically binds to the analyte contained in the test solution. Subsequently, the bound substance is immobilized in the reagent immobilization unit 13, and the remaining unimmobilized labeling reagent flows out to the downstream side of the development layer 14 without being immobilized.

The concentration of the analyte contained in the test solution is calculated by detecting the difference between the absorbance signals of the reagent immobilization section 13 of the chromatography test piece 8 and the dough section 15 and converting it from a known calibration curve. You can ask.

Here, by scanning the chromatographic test piece 8 in the long side direction, it is possible to measure the difference between the absorbance signals of the cloth portion 15 and the reagent immobilization portion 13 with a single light beam. Further, by making the light beam elliptic, the influence of unevenness due to the position of the chromatography test piece 8 in the short side direction is mitigated.

Next, the absorbance measurement will be described. Figure 2
FIG. 3 is a diagram showing an absorbance measurement of a chromatography test piece according to Embodiment 1 of the present invention. FIG. 2A shows the state of development of the solution to be inspected on the chromatography test piece and the irradiation position of the light beam. Also, FIG.
(B) shows the change of the absorbance signal with respect to the measurement time.

The chromatographic test piece 8 is attached to the measuring device, and the test solution 23 is added to the test solution adding section 11. Next, with the development of the solution to be inspected 23, the analyte contained in the solution to be inspected 23 is washed away while being bound to the eluted labeled reagent, and the bound substance is fixed in the reagent immobilization unit 13. The light beam 16 is applied to the reagent immobilization unit 13
When the absorbance is measured in the state of continuously irradiating the upper part, the absorbance signal 24 sharply rises and falls due to the passage of the labeling reagent, and then gradually rises, and again gradually with the drying of the test solution. Fall to.

Therefore, in order to suppress an error in the absorbance measurement, the light beam 16 is kept waiting while being irradiated between the labeling reagent holding section 12 and the reagent immobilization section 13, and the test solution is developed or labeled. The change in absorbance due to the elution of the reagent was detected, and after a lapse of a certain time from this detection, the measurement was automatically started.

Further, the above-mentioned fixed time may affect the developing speed of the test solution depending on the temperature and humidity around the measuring device. Therefore, from the elution of the labeled reagent accompanying the development of the test solution to the measurement of the concentration of the analyte, the temperature and humidity were monitored and corrected for a certain period of time. Further, the operation of the light beam is such that the light beam is alternately turned on and off while the development of the solution to be inspected is detected. Alternatively, the time to detect the development of the solution to be inspected is predicted, and the light beam is turned off until just before the expected arrival time. Alternatively, the output of the light beam was set to be lower than that during measurement while detecting the expansion of the solution to be inspected.

As described above, according to the chromatography quantitative measurement device of the first embodiment, the test solution is added to the chromatographic test piece and the test solution is detected after a certain time from the detection of the development of the test solution. Since the concentration of the analyte contained in the solution is measured, the operator does not need to manually manage the time. In addition, since the elution of the labeled reagent is detected and the measurement is performed, it is possible to distinguish the used test strip from which the labeled reagent has already been eluted.

Further, according to the chromatography quantitative measurement device of the first embodiment, the ambient temperature and humidity are monitored and the time from the detection of the elution of the labeled reagent to the measurement is corrected. It is possible to reduce the influence of the temperature and the humidity on the change of the developing speed of the test solution on the chromatography test piece.

Further, according to the chromatography quantitative measurement device of the first embodiment, while the development of the test solution is detected, the light beam is alternately turned on and off, or the development of the test solution is detected. The time to predict, until just before the predicted arrival time, turn off the laser, or while detecting the development of the solution to be inspected on the chromatographic test piece, set the laser output lower than the time of measurement, or Since these methods were combined, the deterioration of the performance of the chromatographic test piece due to the temperature rise of the laser beam irradiation part on the chromatographic test piece can be prevented. In the first embodiment, the detection of the elution of the labeled reagent has been described, but the same effect can be obtained by detecting the development of the test solution itself.

(Embodiment 2) Next, claim 8 of the present invention
The second embodiment of the invention corresponding to claim 11 will be described with reference to FIG. FIG. 3 is a diagram showing the absorbance measurement of the chromatography test piece according to the second embodiment of the present invention. FIG. 3A shows the state of development of the test solution on the chromatography test piece and the irradiation position of the light beam. Further, FIG. 3B is an enlarged view of a portion showing a rapid increase in the absorbance change in the standby state in the second embodiment of the present invention.

The light beam 16 is made to stand by while being irradiated between the labeled reagent holding section 12 and the reagent immobilization section 13. The absorbance signal at this time monotonically increases with the elution of the labeling reagent. Therefore, by obtaining the slope θ of the time change of the absorbance signal, the developing speed of the solution to be inspected 23 is calculated, and the quality of the performance of the chromatographic test piece is judged from the developing speed. Alternatively, the increase in absorbance due to the elution of the labeling reagent is scanned with a light beam so as to keep it constant,
The development speed of the solution 23 to be inspected is calculated from the scanning speed,
The quality of the chromatographic test piece is judged from the development speed.

Further, the discriminating value of the developing speed was corrected from the result of measuring at least one of the ambient temperature and the humidity when the test solution was spread on the chromatography test piece.

As described above, according to the chromatographic quantitative measuring apparatus of the second embodiment, the development speed after the addition of the solution to be inspected is detected, and the quality of the chromatographic test piece is judged from the development speed. It is possible to determine a defect such as an abnormal clogging of the graph test piece.

Further, the development speed of the test solution is calculated after detecting the time change of the value of the detection signal generated by the elution of the labeled reagent accompanying the development of the test solution. It is possible to determine a defect such as clogging abnormality of one side.

Further, the light beam is scanned so that the rise value of the detection signal generated by the elution of the labeled reagent accompanying the development of the test solution is kept constant, and the test solution is developed from the scanning speed of the light beam. Since the speed is calculated, it is possible to determine a defect such as an abnormal clogging of the chromatography test piece.

Further, since the discriminating value of the developing speed is corrected from the result of measuring at least one of the ambient temperature and the humidity during the developing of the solution to be inspected, it is possible to prevent the erroneous determination of the quality due to the influence of the temperature and the humidity. You can

(Third Embodiment) Hereinafter, the first aspect of the present invention will be described.
A third embodiment of the invention corresponding to claims 2 to 14 will be described with reference to FIG. FIG. 4 is a diagram showing the difference in the absorbance measurement result by the chromatography test piece according to the third embodiment of the present invention depending on the test solution. Figure 4
FIG. 4A shows the scanning state of the light beam on the chromatography test piece, and FIG. 4B shows the change of the absorbance signal with respect to the position of the light beam.

On the chromatography test piece 8, the light beam 16 passes from the upstream side fabric portion 15a to the reagent immobilization portion 13 and scans to the downstream side fabric portion 15b. The absorbance signal at this time differs depending on the type of solution to be inspected. For example, in a blood plasma sample and a whole blood sample, the whole blood sample has a higher overall absorbance. Also, dough part 1
The magnitude of the absorbance at 5 is constant regardless of the concentration of the analyte contained in the test solution.

Therefore, the signal detection position for discriminating the type of the solution to be inspected is located on the downstream side of the reagent immobilization section 13 and the absorbance in the base material portion 15 is detected to detect the known absorbance corresponding to the type of each solution to be inspected. Compared with the size of. Further, the type of the solution to be inspected was discriminated from the magnitude of the absorbance in the dough portion 15, a calibration curve was selected according to the type, and the concentration of the analysis object contained in the solution to be inspected was converted.

As described above, according to the chromatography quantitative measurement device of the third embodiment, the type of the test solution is determined from the detection signal in the dough portion on the chromatographic test piece to which the test solution is added. The type of test solution added to the chromatographic test strip can be determined.

Further, the dough portion for measuring the detection signal is located downstream of the reagent immobilizing portion in the developing direction. Therefore, as compared with the downstream fabric portion of the reagent immobilizing portion, the dough portion remains at the upstream dough portion. It is possible to suppress misjudgment of the type of the solution to be inspected due to the influence of the labeling reagent which is easy to perform.

Further, since the type of the solution to be inspected can be discriminated from the detection signal of the dough part and the calibration curve suitable for the solution to be inspected can be selected in advance, when measuring plural types of the solution to be inspected, the user can It is not necessary to manually enter the type of solution to be inspected into the device, and automatic measurement is possible.

(Fourth Embodiment) The first aspect of the present invention will be described below.
A fourth embodiment of the invention corresponding to claim 5 and claim 16 will be described with reference to FIG. FIG. 5 is a diagram showing the flow of the test solution of the chromatography test piece according to the fourth embodiment of the present invention.

FIG. 5A shows the case where a sufficient amount of the solution to be inspected 23 is added to the inspected solution adding section 11. The added solution to be inspected 23 develops the labeling reagent holding part 12, the upstream side dough part 15a, the reagent immobilization part 13 and the downstream side dough part 15b of the chromatography test strip 8, respectively, and further the downstream dough part 15b. It reaches the downstream end. FIG. 5B shows a case where the test solution 23 added to the test solution adding section 11 is insufficient, and the added test solution 23 is the downstream end of the downstream dough portion 15b. I have not reached the department.

Therefore, the downstream side end of the downstream side fabric portion 15b was irradiated with a light beam, and the value of the detection signal obtained in that case was determined. Further, in order to measure the concentration of the analyte, the same light beam as the light beam 16 that scans before and after the reagent immobilization unit 13 was further scanned up to the downstream end of the downstream cloth 15b.

As described above, according to the chromatography quantitative measurement device of the fourth embodiment, it can be obtained by irradiating the downstream end of the dough portion on the chromatography test piece to which the test solution is added with the light beam. From the detection signal, it was determined that the amount of the test solution added was insufficient and that the chromatographic test piece was poorly developed.Therefore, the amount of the test solution added to the chromatographic test piece was insufficient, or the clogging occurred. It is possible to detect the development failure of the graphographic test piece.

Further, since the light beam was scanned up to the downstream side end of the cloth portion on the chromatography test piece, a new light source was used to detect the insufficient addition amount of the solution to be inspected and the poor development of the chromatography test piece. It is possible to suppress an increase in the size of the device and an increase in the price due to the addition of functions without requiring

(Fifth Embodiment) Hereinafter, the first aspect of the present invention will be described.
A fifth embodiment of the invention corresponding to No. 7 will be described with reference to FIG. FIG. 6 is a diagram showing the absorbance measurement of the chromatography test piece according to the fifth embodiment of the present invention. Figure 6
6A shows the scanning state of the light beam on the chromatography test piece, and FIG. 6B shows the change of the absorbance signal with respect to the position of the light beam.

On the chromatography test piece 8, the light beam 16 passes from the upstream cloth portion 15a to the reagent immobilization portion 13 and scans to the downstream cloth portion 15b.

The magnitude of the absorbance corresponding to the concentration of the analyte is higher than that at the position where the absorbance of the labeling reagent immobilized on the reagent immobilization section 13 is not affected, that is, at the position T where the absorbance signal 24 has a peak. , The value of the absorbance at the position U on the downstream side by the distance D is used as a reference, and the difference E from the peak position T at that time can be obtained. In other words, the absorbance value at the peak position T contains the absorption component of the solution to be inspected itself, but this becomes an error in the measurement of the absorbance of the labeled reagent immobilized in the reagent immobilization unit 13, and therefore the position U
The influence of this error can be eliminated by using the absorbance value at (corresponding to the absorption component of the solution to be inspected itself) as a reference. Further, since the reference position is not the upstream side of the reagent immobilization unit 13 but the position U on the downstream side, the error in the absorbance measurement by the labeling reagent that is likely to remain in the upstream side fabric portion 15a (F in FIG. 6B). Part) can be removed.

As described above, according to the quantitative measurement device for chromatography according to the fifth embodiment, the influence of the reagent immobilization portion on the downstream side of the reagent immobilization portion on the chromatography test piece in the developing direction of the test solution is affected. The detection signal at the reagent immobilization part when the detection signal at the non-existing position is used as the reference value,
Since it is the detection signal of the concentration to be measured, it is possible to suppress the influence of the absorbance measurement error due to the labeling reagent that tends to remain in the upstream side fabric portion as compared with the downstream side fabric portion of the reagent immobilization unit.

(Embodiment 6) Hereinafter, claim 1 of the present invention will be described.
8 and Embodiment 6 of the invention corresponding to Claim 19 will be described with reference to FIG. FIG. 7 is a diagram showing the absorbance measurement of the chromatography test piece according to the sixth embodiment of the present invention. FIG. 7 (a) is a scanning state of the light beam on the chromatography test piece, and FIG. 7 (b).
Shows a state in which steep electrical noise 25 is added to the change of the absorbance signal with respect to the position of the light beam.

On the chromatography test piece 8, the light beam 16 passes from the upstream cloth portion 15a to the reagent immobilization portion 13 and scans to the downstream cloth portion 15b. At this time, the data of the absorbance signal 24 is stored at an interval G at which a smooth change can be sufficiently detected.

Electrical noise added to the absorbance signal 25
Is generated from a power supply (for example, a switching power supply) added to an electric circuit or generated from a circuit that performs digital processing, and shows a very sharp change as compared with the scanning speed of the light beam 16. .

Therefore, when the value of the peak position T of the absorbance signal 24 and the position U on the downstream side of the distance D from the T is obtained,
Each position was associated with the average value of several data before and after. Further, when obtaining the value of the peak position T of the absorbance signal 24 and the position U on the downstream side by the distance D from T,
Each position was made to correspond with an intermediate value of data before and after several data (value of data located in the middle when rearranged in order of size of each data).

The number of data for obtaining the average value and the intermediate value described above is within a range that does not hinder the reading of the smooth change of the absorbance signal 24.

As described above, according to the chromatography quantitative measurement device of the sixth embodiment, the detection signal at the reagent immobilization part is the average value of the values around the extreme value, and the detection signal serving as the reference value is Since the average value of the values before and after the position where there is no influence of the reagent immobilization part is located downstream of the reagent immobilization part in the developing direction of the test solution, even when electrical noise is accidentally added to the detection signal. It is possible to reduce the influence on the calculation result for obtaining the concentration of the analyte.

The detection signal at the reagent immobilization unit is an intermediate value around the extreme value, and the reference detection signal is the reagent immobilization at the downstream side of the reagent immobilization unit in the developing direction of the test solution. Since the intermediate value of the values before and after the position where there is no effect of the oxidization part was set, the average value was used for the effect on the calculation result for obtaining the concentration of the analyte even when electrical noise was accidentally added to the absorbance signal. It can be made smaller than the case.

(Embodiment 7) Hereinafter, claim 2 of the present invention will be described.
Embodiment 7 of the invention corresponding to 0 and claim 21 will be described with reference to FIG. FIG. 8 is a diagram showing the absorbance measurement of the chromatography test piece according to the seventh embodiment of the present invention. FIG. 8 (a) is a scanning state of the light beam on the chromatography test piece, and FIG. 8 (b).
Shows a state in which optical noises 31 and 32 are added to the change of the absorbance signal with respect to the position of the light beam. Further, FIG. 8C shows a normal change of the absorbance signal with respect to the position of the light beam.

On the chromatographic test piece 8, the light beam 16 passes from the upstream cloth portion 15a to the reagent immobilization portion 13 and scans to the downstream cloth portion 15b. At this time, the data of the absorbance signal 24 is stored at an interval G at which a smooth change can be sufficiently detected. In addition, the change amount K before and after the peak position T (interval I) of the absorbance signal 24, which is obtained by measuring the absorbance with the normal chromatographic test piece 8 in advance,
The amount of change L before and after the position U on the downstream side (interval J) is calculated, and K +
The values of α and L + α (α is the tolerance of the noise component) are stored as the discriminant value at each position.

Optical noise added to the absorbance signal 3
1 and 32 are due to the immobilization unevenness 26 (commonly called color unevenness) of the labeling reagent in the reagent immobilization unit 13, the unevenness 27 of development of the labeling reagent due to clogging in the downstream side fabric portion 15b, and the chromatographic test piece 8. This is due to scratches on the surface of. The optical noises 31 and 32 prevent a gradual change in the absorbance signal 24, and depending on the magnitude thereof, normal absorbance measurement cannot be performed.

Therefore, the values before and after the peak position T (interval I) of the absorbance signal 24 are compared, and if the difference between the maximum value and the minimum value exceeds the discriminant value, it is determined that the chromatographic test piece 8 has poor performance. . Further, by comparing the values before and after the position U (interval J) on the downstream side by the distance D from the peak position T of the absorbance signal 24, if the difference between the maximum value and the minimum value exceeds the discriminant value, the chromatography test piece 8 It was judged that the performance was poor.

As described above, according to the chromatography quantitative measurement device of the seventh embodiment, the values before and after the extreme value of the detection signal in the reagent immobilization portion on the chromatography test piece are compared, and the difference is the discriminant value. If it exceeds, it is determined that the performance of the chromatographic test piece is poor, so that it is possible to avoid erroneous measurement due to uneven immobilization of the labeling reagent in the reagent immobilization section, scratches on the surface of the chromatographic test piece, and the like.

Further, the values before and after the position where there is no influence of the reagent immobilization part are compared on the downstream side of the reagent immobilization part on the chromatography test strip in the developing direction, and when the difference exceeds the discriminant value, the chromatography test strip Since it was determined that the performance was poor, it is possible to avoid erroneous measurement due to uneven development of the solution to be inspected due to clogging in the fabric portion, scratches on the surface of the chromatography test piece, and the like.

(Embodiment 8) The second aspect of the present invention will be described below.
An eighth embodiment of the invention corresponding to claims 2 to 25 will be described with reference to FIG. FIG. 9 shows the state of scanning of the light beam on the chromatography test piece according to the eighth embodiment of the present invention and the change in the absorbance signal with respect to the position of the light beam, which are also shown in parallel.

The labeling reagent holding section 12 retains the labeling reagent even after passing through the test solution. That is, when the light beam 16 is scanned from the upstream side of the labeled reagent holding unit 12 in the measurement of the low-concentration analyte, the absorbance of the labeled reagent remaining in the labeled reagent holding unit 12 becomes the peak position. There is. Further, since the residual labeling reagent in the labeling reagent holding section 12 is uniformly distributed, the absorbance 28 in this region has a flat signal.

Therefore, in order to avoid erroneous recognition of the peak position, the light beam 16 was scanned from the position of the upstream side fabric portion 15a excluding the labeling reagent holding portion 12, and the measurement was started. Alternatively, the flat absorbance signal 28 is detected and the reagent immobilization unit 1
It was identified from the absorbance peak position T corresponding to 3.

Further, the width H of the labeling reagent holding portion 12 was obtained from the flat width of the absorbance signal 28 and compared with the specified width.
Further, the flat value of the absorbance signal 28 was detected and the amount of the labeling reagent remaining was determined.

As described above, according to the apparatus for quantitatively measuring chromatography according to the eighth embodiment, since the labeled reagent holding part on the chromatographic test piece was excluded during the concentration measurement, the absorbance in the labeled reagent holding part was measured. Since the measured value is not included, erroneous recognition of the absorbance peak position does not occur, and the normal concentration of the analyte can be detected.

Further, since the region where the value of the detection signal on the chromatography test piece becomes flat is regarded as the region of the labeled reagent holding part, the absorbance peak position is not erroneously recognized,
It is possible to detect the normal concentration of the analyte. Further, the width of the region where the value of the detection signal on the chromatographic test piece is flat is calculated, and since the width is compared with the width of the specified labeling reagent holding portion, the amount of the labeled reagent retained can be confirmed Poor performance of chromatographic test pieces can be determined. Further, since the value at which the detection signal on the chromatography test piece becomes flat is detected and the amount of the residual labeling reagent is confirmed from the value, it is possible to confirm whether the labeling reagent has flowed normally.

(Ninth Embodiment) The second aspect of the present invention will be described below.
A sixth embodiment of the invention corresponding to claim 6 and claim 27 will be described with reference to FIG. FIG. 10 shows the state of scanning of the light beam on the chromatography test piece according to the ninth embodiment of the present invention and the change in the absorbance signal with respect to the position of the light beam, which are also shown in parallel.

The labeled reagent holding section 12 retains the labeled reagent even after passing through the test solution. That is, in the measurement of the low-concentration analyte, when the light beam 16 is scanned from the position of the labeled reagent holding unit 12, the absorbance of the labeled reagent remaining in the labeled reagent holding unit 12 may reach the peak position. is there.

Therefore, the rising portion 29 and the falling portion 30 were detected from the change in the inclination of the absorbance signal 24, and the maximum position in the region sandwiched by the rising portion 29 and the falling portion 30 was recognized as the peak position T. Further, the distance between the rising portion 29 and the falling portion 30 was obtained and compared with the width of the prescribed reagent immobilization portion 13.

As described above, according to the chromatographic quantitative measurement device of the ninth embodiment, the rising and falling edges of the detection signal are recognized and the extreme value of the detection signal is obtained. Does not occur, and the normal concentration of the analyte can be detected.

Further, the rising and falling edges of the detection signal were recognized, the interval between the rising and falling edges was calculated, and the size of the interval was compared with the width of the prescribed reagent immobilization section. You can check the width of the converted part. Therefore, it is possible to determine the poor performance of the chromatography test piece.

[0098]

As described above, the chromatography quantitative measurement device according to claim 1 of the present invention comprises a developing layer for spreading the test solution and a measurement in the test solution on a part of the developing layer. A reagent immobilization portion formed by immobilizing a reagent for an object, and a labeling reagent formed by holding a labeling reagent that can be eluted by the development of the test solution in another part of the development layer A chromatographic test piece comprising a holding part and the reagent immobilization part from the spreading layer, and a dough part which is a part excluding the labeled reagent holding part, is irradiated with a light beam emitted from a light source, Chromatography in which an optical signal is detected by using transmitted light or reflected light from a chromatographic test piece, and the concentration of an analyte contained in the test solution is quantitatively measured from the signal. In an amount measuring device, the chromatography inspection target solution to the specimen, the after a certain time the development of the inspection target solution from the detection anywhere,
Since the concentration of the analyte contained in the solution to be inspected is measured, the measurer does not need to manually manage the time.

The chromatography quantitative measurement device according to a second aspect of the present invention is the chromatography quantitative measurement device according to the first aspect, wherein the detection of the development of the test solution occurs by the elution of the labeling reagent. Since the change is performed by detecting the change in the detection signal, it is not necessary for the measurer to manually manage the time. In addition, since the elution of the labeled reagent is detected and the measurement is performed, it is possible to distinguish the used test strip from which the labeled reagent has already been eluted.

The chromatography quantitative measurement device according to claim 3 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein a test solution is added to the chromatography test piece, Since the development of the solution to be inspected is detected in the region from the labeled reagent holding section to the reagent immobilization section, the operator does not need to manually manage the time. Also,
Since the elution of the labeled reagent is detected and the measurement is performed, it is possible to distinguish the used test strip from which the labeled reagent has already been eluted.

The chromatography quantitative measuring device according to claim 4 of the present invention is the same as the chromatography quantitative measuring device according to claim 1 or 2,
Since at least one of the humidity and humidity is monitored and the preset fixed time for measuring the concentration of the analyte is corrected, the ambient temperature and humidity are measured on the chromatographic test piece. It is possible to reduce the influence on the change of the developing rate of the solution.

The chromatography quantitative measurement device according to claim 5 of the present invention is the chromatography quantitative measurement device according to claim 1 or 2, wherein the light source of the light source is detected while the development of the test solution is detected. Since the lighting and the extinction are alternately repeated, it is possible to prevent the deterioration of the performance of the chromatographic test piece due to the temperature rise of the laser light irradiation part on the chromatographic test piece.

The chromatography quantitative measuring device according to claim 6 of the present invention is the chromatography quantitative measuring device according to claim 1 or 2, wherein the light source detects the development of the test solution. Since the light is turned off until immediately before, it is possible to prevent the performance of the chromatography test piece from being deteriorated due to the temperature rise of the laser light irradiation part on the chromatography test piece.

The chromatography quantitative measuring device according to claim 7 of the present invention is the chromatography quantitative measuring device according to claim 1 or 2, wherein the output of the light source is detected while the development of the test solution is detected. Since it was made smaller than when measuring the concentration of the analyte, as the temperature of the laser light irradiation part on the chromatography test piece rises,
It is possible to prevent deterioration of the performance of the chromatography test piece.

The chromatography quantitative measuring device according to claim 8 of the present invention comprises a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement device for performing optical signal detection using transmitted light or reflected light of the above and quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal. In the chromatography the inspection target solution to the specimen, said detecting a development speed after inspection target solution, since from the development speed so as to determine the quality of performance of the chromatography specimen,
Defects such as abnormal clogging of chromatographic test pieces can be determined.

The chromatographic quantitative measuring device according to claim 9 of the present invention is the chromatographic quantitative measuring device according to claim 8, wherein the developing speed is the spread of the test solution on the chromatographic test piece. Since the time change of the value of the detection signal caused by the outflow of the labeled reagent due to the above is detected and calculated, it is possible to determine the defect such as the clogging abnormality of the chromatographic test piece.

[0107] Further, the chromatographic quantitative measuring device according to claim 10 of the present invention is the chromatographic quantitative measuring device according to claim 8, wherein the developing speed is the spread of the test solution on the chromatographic test piece. Generated by the elution of the labeled reagent accompanying the above, the light beam was scanned so that the rise value of the detection signal was kept constant, and the calculation was made from the scanning speed of the light beam. It is possible to determine the defect.

Further, the chromatography quantitative measuring device according to claim 11 of the present invention is the chromatography quantitative measuring device according to claim 8 in which the surrounding environment at the time of developing the test solution onto the chromatographic test piece From the result of measuring at least one of the temperature and humidity, to determine the quality of the performance of the chromatographic test piece, so as to correct the determination value of the development speed,
It is possible to prevent erroneous determination of pass / fail due to the influence of temperature and humidity.

[0109] Furthermore, in the chromatography quantitative measuring device according to the twelfth aspect of the present invention, a developing layer for spreading the solution to be inspected and a reagent for a measurement object in the solution to be inspected are provided in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the set, from the detection signal in the dough portion on the chromatographic test piece to which the test solution is added, since the type of the test solution is determined, the type of the test solution added to the chromatographic test piece Can be determined.

[0110] According to a thirteenth aspect of the present invention, the chromatographic quantitative measurement device according to the twelfth aspect of the present invention is the chromatographic quantitative measurement device according to the twelfth aspect. Since it is located on the downstream side, it is possible to suppress erroneous determination of the type of the solution to be inspected due to the influence of the labeling reagent that tends to remain on the upstream fabric portion, as compared with the downstream fabric portion of the reagent immobilization unit.

The chromatography quantitative measurement device according to claim 14 of the present invention is the chromatography quantitative measurement device according to claim 12, wherein a calibration curve suitable for the solution to be tested can be selected in advance. When measuring a plurality of types of test solutions, the user does not need to manually enter the types of test solutions into the apparatus, and automatic measurement is possible.

Further, the chromatography quantitative measuring device according to claim 15 of the present invention comprises a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the setting, the downstream end of the dough portion on the chromatographic test strip to which the test solution has been added, from the detection signal obtained by irradiating a light beam, the addition amount of the test solution is insufficient, and the chromatographic test Since the defective development of the strip is determined, it is possible to detect the poor deployment of the chromatographic test strip caused by insufficient addition of the test solution added to the chromatographic test strip or clogging.

The chromatography quantitative measuring device according to claim 16 of the present invention is the chromatography quantitative measuring device according to claim 15, wherein the light beam is
Since the scanning is performed from the upstream end to the downstream end of the dough portion on the chromatography test piece, a new light source is used to detect insufficient addition of the solution to be inspected and poor development of the chromatography test piece. It is not necessary, and has the effect of suppressing the size increase and price increase of the device due to the addition of functions.

Further, the chromatography quantitative measuring device according to claim 17 of the present invention comprises a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the arrangement, the detection signal at the reagent immobilization unit, when the detection signal at the position downstream of the reagent immobilization unit in the developing direction and at a position not affected by the reagent immobilization unit is a reference value, Since it was made to be the detection signal of the concentration measurement, compared with the downstream fabric part of the reagent immobilization part,
It is possible to suppress the influence of the absorbance measurement error due to the labeling reagent that tends to remain in the upstream side fabric portion.

[0115] Also, the chromatography quantitative measurement device according to claim 18 of the present invention is the chromatography quantitative measurement device according to claim 17, wherein the detection signal of the concentration measurement is before and after the extreme value of the reagent immobilization part. The average value of the values, the detection signal to be the reference value, the downstream of the reagent immobilization portion in the developing direction of the solution to be inspected, and the average value of the values before and after the position not affected by the reagent immobilization portion. Therefore, even if electrical noise is accidentally added to the detection signal, it is possible to reduce the influence on the calculation result for obtaining the concentration of the analyte.

[0116] Further, the chromatography quantitative measuring device according to claim 19 of the present invention is the chromatography quantitative measuring device according to claim 17, wherein the detection signal of the concentration measurement is before and after the extreme value of the reagent immobilization part. The intermediate value of the value, the detection signal to be the reference value, the intermediate value of the value before and after the position where there is no influence of the reagent immobilization unit downstream of the reagent immobilization unit in the developing direction of the test solution. Therefore, even when electrical noise is accidentally added to the absorbance signal, the influence on the calculation result for obtaining the concentration of the analyte can be further reduced as compared with the case of using the average value.

Further, the chromatography quantitative measurement device according to claim 20 of the present invention is the chromatography quantitative measurement device according to claim 17, in which the values before and after the extreme value of the detection signal in the reagent immobilization section are compared. , If the difference exceeds the discriminant value, it was determined that the performance of the chromatography test piece is poor, so uneven immobilization of the labeling reagent in the reagent immobilization section, scratches on the surface of the chromatography test piece, etc. , You can avoid erroneous measurements.

[0118] The chromatography quantitative measurement device according to a twenty-first aspect of the present invention is the chromatography quantitative measurement device according to the seventeenth aspect, wherein the reagent is immobilized on the downstream side of the reagent immobilization section in the developing direction. The values before and after the position where there is no effect of the part is compared, and if the difference exceeds the discriminant value, it was determined that the performance of the chromatography test piece was poor, so the development unevenness of the test solution due to clogging in the dough part and In addition, it is possible to avoid erroneous measurement due to scratches on the surface of the chromatography test piece.

[0119] Further, the chromatography quantitative measuring device according to claim 22 of the present invention comprises a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the measurement, when measuring the concentration, the measurement was carried out excluding the labeled reagent holding part on the chromatography test piece, so the absorbance measurement value in the labeled reagent holding part was not included, so the misrecognition of the absorbance peak position occurred. Without doing so, it is possible to detect the concentration of the normal analyte.

[0120] The chromatography quantitative measuring device according to claim 23 of the present invention is a spreading layer for spreading a test solution, and a reagent for a measurement object in the test solution in a part of the spreading layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In the position, the area where the value of the detection signal on the chromatography test piece becomes flat is considered to be the area of the labeled reagent holding part, so that the false recognition of the absorbance peak position does not occur, and the normal analyte It is possible to detect the concentration.

The chromatography quantitative measurement device according to a twenty-fourth aspect of the present invention is the chromatography quantitative measurement device according to the twenty-third aspect, in which the width of the region where the value of the detection signal on the chromatography test piece is flat is set. Since it was calculated and the width was compared with the width of the specified labeled reagent holding portion, the amount of the labeled reagent held could be confirmed,
Poor performance of chromatographic test pieces can be determined.

[0122] The chromatography quantitative measurement device according to a twenty-fifth aspect of the present invention is the chromatography quantitative measurement device according to the twenty-third aspect, wherein a value at which the detection signal on the chromatography test piece becomes flat is detected, and Since the amount of the residual labeling reagent is confirmed from the value, it is possible to confirm whether the labeling reagent has flowed normally.

Further, the chromatography quantitative measuring device according to claim 26 of the present invention is a developing layer for spreading the solution to be inspected, and a reagent for the object to be measured in the solution to be inspected in a part of the developing layer. A reagent immobilization unit formed by immobilization, a labeling reagent holding unit formed by holding a labeling reagent that can be eluted by the development of the solution to be inspected in another part of the development layer, and Chromatography test piece comprising the reagent immobilization part from the spreading layer, and the dough part which is a part excluding the labeled reagent holding part, irradiating a light beam emitted from a light source, from the chromatography test piece Chromatographic quantitative measurement in which the optical signal is detected by using the transmitted light or the reflected light, and the concentration of the analyte contained in the test solution is quantitatively measured from the signal. In this case, since the rising edge and the falling edge of the detection signal are recognized and the extreme value of the detection signal is obtained, erroneous recognition of the absorbance peak position does not occur, and it is possible to detect the concentration of the normal analyte. Become.

[0124] The chromatography quantitative measuring device according to a twenty-seventh aspect of the present invention is the chromatography quantitative measuring device according to the twenty-sixth aspect, in which the rising edge and the falling edge of the detection signal are recognized and the rising edge and the rising edge are detected. The width of the reagent immobilization portion can be confirmed by calculating the interval between the falling edges and comparing the size of the space with the width of the prescribed reagent immobilization portion. Therefore, it is possible to determine the poor performance of the chromatography test piece.

[Brief description of drawings]

FIG. 1 is a schematic configuration diagram of a chromatography quantitative measurement device according to a first embodiment of the present invention.

FIG. 2 is a diagram showing changes in absorbance with development of a solution to be inspected according to the first embodiment of the present invention.

FIG. 3 is a diagram showing a change in absorbance in a standby state according to the second embodiment of the present invention.

FIG. 4 is a diagram showing the results of measuring the absorbance of a chromatographic test piece according to different test solutions in the third embodiment of the present invention.

FIG. 5 is a diagram showing development of an inspected solution of a chromatography test piece according to a fourth embodiment of the present invention.

FIG. 6 is a diagram showing an absorbance difference measurement of a chromatography test piece according to a fifth embodiment of the present invention.

FIG. 7 is a diagram showing electrical noise of an absorbance signal of a chromatography test piece according to the sixth embodiment of the present invention.

FIG. 8 is a diagram showing optical noise of an absorbance signal of a chromatography test piece according to the seventh embodiment of the present invention.

FIG. 9 is a diagram showing the absorbance including the labeling reagent holding part of the chromatography test piece according to the eighth embodiment of the present invention.

FIG. 10 is a diagram showing a method of detecting an absorbance peak value of a chromatography test piece according to Embodiment 9 of the present invention.

FIG. 11 is a schematic configuration diagram of a conventional chromatography test device.

[Explanation of symbols]

1 lamp 2 reflector 3 diffraction grating 4 openings 5 glass plates 6 Reference light 7,10 Photomultiplier tube 8 Chromatography test piece 9 scattered light 11 solution to be inspected 12 Labeling reagent holder 13 Reagent immobilization unit 14 Deployment layer 15 Dough 15a upstream side fabric part 15b Downstream fabric part 16,33 light beam 17 Semiconductor laser 18 Collimating lens 19 Beam splitter 20, 22 Photodiode 21 Cylindrical lens 23 Inspected solution 24 Absorbance signal 25 electrical noise 26 Color unevenness 27 Development unevenness 28 Flat part 29 Rising part 30 Falling part 31,32 Optical noise

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Kaoru Shigematsu             1 Juden Matsushita, 1-8 Koshinmachi, Takamatsu City, Kagawa Prefecture             Child Industry Co., Ltd. F-term (reference) 2G054 EA04 EA05                 2G059 AA01 BB04 BB12 BB13 CC16                       EE01 EE02 FF04 FF08 FF12                       GG01 GG07 JJ05 JJ11 JJ22                       KK01 KK03 MM03 MM05 MM10                       NN01 NN09

Claims (27)

[Claims] 1. A spreading layer for spreading a test solution, and a reagent immobilization section formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer,
A labeled reagent holding part formed by holding a labeled reagent which can be eluted by the development of the solution to be inspected in another part of the developed layer, a reagent immobilization part from the developed layer, and a labeled reagent retention Chromatography test piece having a cloth part which is a part excluding the part, irradiating a light beam emitted from a light source, an optical signal using transmitted light or reflected light from the chromatography test piece Detecting, in the chromatographic quantitative measuring device for quantitatively measuring the concentration of the analyte contained in the test solution from the signal, the test solution is added to the chromatography test piece,
A quantitative assay device for chromatography, characterized in that the concentration of an analyte contained in the solution to be inspected is measured after a predetermined time has elapsed after detecting the development of the solution to be inspected at an arbitrary location. 2. The chromatographic quantitative measurement device according to claim 1, wherein the detection of the development of the test solution is performed by detecting a change in a detection signal generated by the elution of the labeled reagent. Graphimetric quantitative measuring device. 3. The chromatography quantitative measurement device according to claim 1 or 2, wherein a test solution is added to the chromatography test piece,
A chromatography quantitative measurement device, wherein the development of the test solution is detected in a region from the labeled reagent holding unit to the reagent immobilization unit. 4. The chromatography quantitative measurement device according to claim 1 or 2, wherein at least one of temperature and humidity is monitored to set a preset fixed time for measuring the concentration of the analyte. A chromatographic quantitative measuring device characterized by: 5. The chromatography quantitative measurement device according to claim 1 or 2, wherein the light source is turned on and off alternately while detecting the development of the solution to be inspected. measuring device. 6. The chromatographic quantitative measurement apparatus according to claim 1, wherein the light source is turned off until just before detecting the development of the test solution. apparatus. 7. The chromatography quantitative measurement device according to claim 1 or 2, wherein the output of the light source is made smaller than that during measurement of the concentration of the analyte while detecting the development of the solution to be inspected. Chromatographic quantitative measuring device. 8. A spreading layer for spreading a test solution, and a reagent immobilization section formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer,
A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the solution to be inspected in another part of the developed layer, a reagent immobilization part from the developed layer, and the labeled reagent retention Chromatography test piece having a cloth part which is a part excluding the part is irradiated with a light beam emitted from a light source, and an optical signal is obtained by using transmitted light or reflected light from the chromatography test piece. Performing detection, in the chromatographic quantitative measurement device for quantitatively measuring the concentration of the analyte contained in the test solution from the signal, the test solution is added to the chromatography test piece,
A chromatographic quantitative measuring device, characterized in that the development speed after the test solution is added is detected, and the quality of the performance of the chromatography test piece is judged from the development speed. 9. The chromatography quantitative measurement device according to claim 8, wherein the development speed is generated by the outflow of the labeled reagent accompanying the development of the test solution onto the chromatography test strip.
A chromatographic quantitative measurement device characterized by detecting and calculating a change over time in the value of a detection signal. 10. The chromatographic quantitative measurement device according to claim 8, wherein the development speed is generated by the elution of a labeling reagent accompanying the development of a test solution onto the chromatography test strip.
A chromatographic quantitative measurement device, characterized in that a light beam is scanned so that the rise value of the detection signal is kept constant, and calculation is performed from the scanning speed of the light beam. 11. The chromatography quantitative measurement device according to claim 8, wherein at least one of ambient temperature and humidity at the time of developing the test solution on the chromatography test piece is measured, A chromatographic quantitative measurement device characterized by determining the quality of performance of a chromatographic test piece and correcting the discriminant value of the development speed. 12. A spreading layer for spreading a test solution, a reagent immobilization section formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer, and the spreading. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece having a dough part which is a portion excluding the labeling reagent holding part, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device for performing optical signal detection and quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal, on the chromatographic test strip to which the solution to be inspected is added A quantitative measurement device for chromatography characterized in that the type of test solution is discriminated from the detection signal in the dough part. 13. The chromatographic quantitative measurement device according to claim 12, wherein the dough part for measuring the detection signal is located downstream of the reagent immobilization part in the developing direction. 14. The chromatographic quantitative measurement device according to claim 12, wherein a calibration curve suitable for the solution to be inspected can be selected in advance. 15. A spreading layer for spreading a test solution, a reagent immobilization portion formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer, and the spreading layer. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece having a dough part which is a portion excluding the labeling reagent holding part, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device for performing optical signal detection and quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal, on the chromatographic test strip to which the solution to be inspected is added Chromatography characterized by determining the addition amount of the solution to be inspected and the poor development of the chromatography test piece from the detection signal obtained by irradiating the downstream end of the dough part with a light beam. Quantitative measuring device. 16. The chromatography quantitative measurement device according to claim 15, wherein the light beam scans from the upstream end to the downstream end of the cloth portion on the chromatography test piece. Quantitative measuring device. 17. A spreading layer for spreading a test solution, a reagent immobilization portion formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer, and the spreading layer. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece having a dough part which is a portion excluding the labeling reagent holding part, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device for performing optical signal detection by means of, and quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal, on the downstream side in the developing direction from the reagent immobilization unit. And a detection signal at the reagent immobilization unit when a detection signal at a position not affected by the reagent immobilization unit is used as a reference value, is used as a detection signal for the concentration measurement. Quantitative measuring device. 18. The chromatographic quantitative measurement device according to claim 17, wherein the detection signal for the concentration measurement is an average value of values around the extreme value of the reagent immobilization unit, and the detection signal serving as the reference value is On the downstream side of the developing direction of the test solution from the reagent immobilization unit,
Moreover, the chromatographic quantitative measurement device is characterized in that it is an average value of values before and after a position that is not affected by the reagent immobilization unit. 19. The chromatography quantitative measurement device according to claim 17, wherein the detection signal for the concentration measurement is an intermediate value between the extreme values before and after the extreme value of the reagent immobilization section, and the detection signal serving as the reference value is On the downstream side of the developing direction of the test solution from the reagent immobilization unit,
A chromatographic quantitative measuring device, characterized in that it is an intermediate value of values before and after the position where the reagent immobilization part does not affect. 20. The chromatography quantitative measurement device according to claim 17, wherein the values before and after the extreme value of the detection signal in the reagent immobilization unit are compared, and when the difference exceeds the discriminant value, the performance of the chromatography test piece is measured. A chromatographic quantitative measuring device characterized by determining a defect. 21. The chromatographic quantitative measurement device according to claim 17, wherein the values before and after the position where there is no influence of the reagent immobilization unit are compared on the downstream side of the reagent immobilization unit in the developing direction, and the difference is determined. When the value exceeds the value, it is determined that the performance of the chromatographic test piece is poor, and the chromatographic quantitative measurement device is characterized. 22. A spreading layer for spreading a test solution, a reagent immobilization section formed by immobilizing a reagent for a measurement target in the test solution on a part of the spreading layer, and the spreading. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece comprising a dough portion which is a portion excluding the labeling reagent holding portion, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device for quantitatively measuring the concentration of the analyte contained in the solution to be inspected from the signal by performing optical signal detection using the signal, the labeling reagent on the chromatographic test strip during concentration measurement A chromatographic quantitative measuring device, characterized in that the measurement is performed excluding the holding part. 23. A spreading layer for spreading the solution to be inspected, a reagent immobilization portion formed by immobilizing a reagent for a measurement object in the solution to be inspected on a part of the development layer, and the development. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece having a dough part which is a portion excluding the labeling reagent holding part, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device for optically detecting the concentration of the analyte contained in the solution to be inspected from the signal, the value of the detection signal on the chromatographic test piece is flat. The region to be regarded as is regarded as the region of the labeled reagent holding section. 24. The chromatography quantitative measurement device according to claim 23, wherein the width of the region where the value of the detection signal on the chromatography test piece becomes flat is calculated, and the width is compared with the width of the prescribed labeling reagent holding part. A chromatographic quantitative measurement device characterized by: 25. The chromatography quantitative measurement device according to claim 23, wherein a value at which the detection signal on the chromatography test piece becomes flat is detected, and the amount of the residual labeling reagent is confirmed from the value. Chromatographic quantitative measuring device. 26. A spreading layer for spreading a test solution, a reagent immobilization section formed by immobilizing a reagent for a measurement object in the test solution on a part of the spreading layer, and the spreading. A labeled reagent holding part formed by holding a labeled reagent that can be eluted by the development of the test solution in the other part of the layer, and the reagent immobilization part from the developed layer,
And a chromatography test piece having a dough part which is a portion excluding the labeling reagent holding part, irradiating a light beam emitted from a light source, and utilizing transmitted light or reflected light from the chromatography test piece. In the chromatographic quantitative measurement device that performs optical signal detection by using the above-mentioned signal and quantitatively measures the concentration of the analyte contained in the test solution from the signal, recognizes the rising and falling edges of the detection signal, A chromatographic quantitative measuring device characterized by obtaining an extreme value of the detection signal. 27. The chromatography quantitative measurement device according to claim 26, wherein the rising and the falling of the detection signal are recognized, the interval between the rising and the falling is calculated, and the size of the interval is A chromatographic quantitative measuring device, characterized in that the width is compared with the width of a prescribed reagent immobilization portion.