JP2011214862A - Analyzer and method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To understand the amount and the viscosity of a specimen prior to inspection, in advance, and to carry out additional processings.SOLUTION: A test chip 10, a specimen container CB and a nozzle chip NC are loaded to an analyzer 1. The specimen and a reagent are mixed inside a specimen processing means 20 so as to generate a specimen solution. The specimen solution is injected from the nozzle chip NC to the test chip 10. A weight measurement means 60 measures the weight of the nozzle chip NC, prior to the injection and the weight of the nozzle chip NC, after the injection so as to detect a weight change ΔW. A determination means 70 determines whether the weight change ΔW is smaller than a predetermined range ΔWref. If the weight change ΔW is smaller than the predetermined range ΔWref, the specimen processing means 20 carries out an additional processing of additionally injecting a dilution liquid and the specimen solution to the test chip 10.

Description

  The present invention relates to an analyzer and method for performing quantitative or qualitative measurement on a test substance in a specimen.

  In recent years, POCT (Point of Care Testing) analyzers have been proposed for injecting specimens such as blood, plasma, and urine to be tested into a test chip and measuring them simply using the test chip. Among these, analyzers that perform tests using antigen-antibody reactions are known. For example, the sample is introduced into a test chip provided with an insoluble carrier, and an analyte using an immunochromatography technique for analyzing the coloration of a test substance by a sample is introduced into the test chip provided with an insoluble carrier or a test chip provided with a microchannel. Various analyzers are known, such as observing fluorescence from a fluorescent label bound to a test substance.

  Both the immunochromatograph and the fluorescence observation described above are performed on the assumption that a predetermined amount of sample flows at a predetermined flow rate, and it is proposed to measure the flow rate of the sample and the amount of the sample by various methods. (See Patent Documents 1-3). For example, Patent Document 1 discloses optically measuring the development speed or development time of a specimen in an immunochromatograph. Patent Document 2 discloses detecting the amount of the sample injected into the test chip based on the development speed of the sample. Patent Document 3 discloses that the amount of the sample injected into the test chip is measured based on the weight.

International Publication No. 2007/007849 JP 2009-85695 A JP 2006-333783 A

  However, in Patent Documents 1 and 2, since the specimen deployment speed is measured after the specimen has already been deployed, if the specimen deployment speed does not reach the predetermined speed, the specimen already deployed is normal. A re-inspection will be performed because a proper inspection cannot be performed. As a result, there is a problem that the specimen is wasted. Further, since the flow rate of the sample depends not only on the amount of the sample but also on the viscosity, even if the amount of the sample is detected as in Patent Documents 2 and 3, accurate analysis cannot be performed unless the viscosity can be detected. There is a problem.

  Therefore, an object of the present invention is to provide an analyzer and method that can grasp that a sample can obtain an appropriate flow rate based on the weight of the sample.

  An analyzer according to the present invention includes a weight measuring unit for measuring the weight of a sample injected into a test chip and a weight measuring unit in an analyzer for inspecting a test substance in the sample while flowing the sample through the test chip. Determining means for determining whether or not the amount and viscosity of the sample are within a preset specified range based on the weight measured by the step, and the viscosity of the sample is outside the specified range in the determining means When the determination is made, a sample processing means for performing an additional process so that the viscosity of the sample is within a specified range with respect to the sample in the test chip is provided.

  The analysis method of the present invention is an analysis method for inspecting a test substance in a specimen while flowing the specimen through the test chip, and measures the weight of the specimen injected into the test chip, and the specimen is based on the measured weight. If the sample viscosity is outside the specified range, and if the sample viscosity is outside the specified range, the amount or viscosity of the sample relative to the sample in the test chip The additional processing is performed so that is within the specified range.

  Here, the analyzer is not limited as long as it can analyze the test substance while flowing the sample. For example, the analyzer can analyze the test substance by detecting fluorescence, and the test chip flows through the sample. You may have a path | route and the test area | region for catching the to-be-tested substance formed in the flow path. Alternatively, the analysis device analyzes the test substance by detecting the coloration, and the test chip reacts to the insoluble carrier in which the specimen flows by capillary action and the test substance in the specimen formed on the insoluble carrier. And a test area that is colored.

  The weight measuring means may be any method as long as it detects the weight of the specimen injected into the test piece. For example, when the specimen is injected from the specimen processing means into the test chip, The change in weight may be measured as the weight of the specimen, or the change in weight before and after injection of the test chip may be measured as the weight of the specimen.

  Further, the determination means only needs to determine whether or not the amount and viscosity of the specimen are within a preset specified range based on the weight. For example, the determination means compares the weight change with a set reference value. Accordingly, it may be determined whether or not the amount and viscosity of the specimen are within a specified range.

  Furthermore, the sample processing means may be one that additionally injects a diluent into the sample in the test chip, or may be one that additionally injects the sample into the test chip.

  The analyzer may further include a temperature sensor that detects the temperature of the sample to be injected. At this time, the determination means may detect the viscosity of the specimen based on the temperature and weight of the specimen.

  According to the analysis apparatus and method of the present invention, the weight of the sample injected into the test chip is measured, and whether or not the amount and viscosity of the sample are within a preset specified range based on the measured weight. If the amount or viscosity of the sample is determined to be outside the specified range, additional processing is performed on the sample in the test chip so that the amount or viscosity of the sample is within the specified range. Before the specimen flows in the test chip, the viscosity of the specimen is detected from the weight of the specimen, it is determined whether or not the examination can be performed without abnormality, and the examination can be performed without abnormality. An accurate inspection can be performed without waste.

  In addition, when the temperature sensor for detecting the temperature of the specimen is further provided and the determination means detects the viscosity of the specimen based on the temperature and the weight, the viscosity of the specimen is based only on the weight based on the knowledge that changes depending on the temperature. In addition, the abnormality can be accurately determined using the temperature.

  In addition, if the sample processing means additionally injects a diluent to the sample in the test chip or additionally injects the sample, an abnormality may occur if the sample is additionally processed to flow at a predetermined flow rate. It is possible to perform a highly accurate inspection.

The schematic diagram which shows preferable embodiment of the analyzer of this invention The block diagram which shows preferable embodiment of the analyzer of this invention The schematic diagram which shows an example of the test chip | tip used in the analyzer of this invention The schematic diagram which shows an example of the test chip | tip used in the analyzer of this invention FIG. 2 is a schematic diagram showing how a sample is extracted in the sample processing means of FIG. FIG. 2 is a schematic diagram showing how a sample is mixed with a reagent in the sample processing means of FIG. Graph showing an example of the relationship between weight change and viscosity The flowchart which shows preferable embodiment of the analysis method of this invention The schematic diagram which shows an example of another test chip used in the analyzer of this invention The schematic diagram which shows an example of another test chip used in the analyzer of this invention Schematic diagram showing an example of the sample processing means used in the test chip of FIGS. 9 and 10

    Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. FIG. 1 is a schematic configuration diagram of an analyzer 1 according to the present invention. The analyzer 1 is an immune analyzer using surface plasmon resonance, for example. When the analysis is performed by the analyzer 1, the sample container CB containing the sample, the nozzle chip NC used for extracting the sample and the reagent, the test chip 10 in which the reagent cell and the microchannel are formed, Is loaded. The sample container CB, the nozzle tip NC, and the test tip 10 are all disposable items that are discarded once used.

  FIG. 2 is a block diagram showing a preferred embodiment of the analyzer of the present invention. 2 includes a sample processing unit 20, a light irradiation unit 30, a reading unit 40, a data analysis unit 50, and the like. The sample processing means 20 extracts a sample from the sample container CB containing the sample using the nozzle chip NC, and generates a sample solution obtained by mixing and stirring the extracted sample with a reagent.

  Here, FIG. 3 is a schematic diagram showing an example of the test chip 10. The test chip 10 has a structure in which an inlet 12, an outlet 13, sample cells 14 a and 14 b, and a flow path 15 are formed in a main body 11 made of a light transmissive resin. The injection port 12 communicates with the discharge port 13 via the flow channel 15, and by applying a negative pressure from the discharge port 13, the specimen is injected from the injection port 12, flows into the flow channel 15, and is discharged from the discharge port 13. The The sample cells 14a and 14b are containers for storing a fluorescent reagent (second antibody) to be mixed with the specimen in the specimen container CB. Note that the openings of the sample cells 14a and 14b are sealed with a sealing member, and the sealing member is pierced when the specimen and the fluorescent reagent are mixed.

  Further, a test region TR for detecting a test substance in the specimen and a control region CR provided on the downstream side of the test region TR are formed in the flow path 15. A first antibody is immobilized on the test region TR, and the labeled antibody is captured by a so-called sandwich method. In addition, a reference antibody is fixed to the control region CR, and the second antibody captures the fluorescent substance when the sample solution flows on the control region CR. Two control regions CR are formed, a so-called negative control region CR for detecting non-specific adsorption and a so-called positive control region CR for detecting a difference in reactivity due to individual differences. Is formed.

  When the start of analysis is instructed, the sample processing means 20 aspirates the sample from the sample container CB using the nozzle tip NC as shown in FIG. Thereafter, the sample processing means 20 punctures the seal member of the sample cell 14a as shown in FIG. 5, mixes and stirs the sample with the reagent in the sample cell 14a, and then sucks the sample solution again using the nozzle tip NC. . This operation is similarly performed for the sample cell 14b. Then, a sample solution is generated in which the second antibody B2, which is a second binding substance specifically binding in the reagent, to the test substance (antigen) A present in the sample is modified on the surface. Then, the sample processing means 20 installs the nozzle chip NC containing the sample solution on the injection port 12, and the sample solution in the nozzle chip NC flows into the flow path 15 by the negative pressure from the discharge port 13.

  In addition, although the case where the sample processing unit 20 supplies the sample solution in which the sample and the reagent are mixed into the flow path 15 is illustrated, the reagent is filled in the flow path 15 in advance, and the sample processing means 20 Only the specimen may be allowed to flow from the inlet 12.

  FIG. 6 is a schematic diagram showing an example of the light irradiation means 30 and the reading means 40. In FIG. 6, the description will be given focusing on the test region TR, but the excitation light L is similarly applied to the control region CR. The light irradiating means 30 in FIG. 2 irradiates the dielectric plate 17 and the metal film 16 in the test region TR through the prism with the excitation light L from the back side of the test chip 10 at an incident angle that is a total reflection condition. . The reading means 40 is composed of, for example, a photodiode, CCD, CMOS, or the like, and detects fluorescence generated from the test region TR as a fluorescence signal FS by irradiation of the excitation light L of the light irradiation means 30.

  Then, the excitation light L is incident on the interface between the dielectric plate 17 and the metal film 16 at a specific incident angle equal to or greater than the total reflection angle by the light irradiation means 30, thereby entering the sample S on the metal film 16. The evanescent wave Ew oozes out, and surface plasmons are excited in the metal film 16 by the evanescent wave Ew. This surface plasmon causes an electric field distribution on the surface of the metal film 16 to form an electric field enhancement region. Then, the bound fluorescent labeling substance F is excited by the evanescent wave Ew and generates enhanced fluorescence. The reading means 40 detects this fluorescence.

  The data analysis means 50 in FIG. 2 analyzes the test substance based on the temporal change of the fluorescence signal FS detected by the reading means 40. Specifically, since the fluorescence intensity changes depending on the amount of the fluorescent labeling substance F bound thereto, the fluorescence intensity changes with time. The data analysis means 50 acquires a plurality of fluorescent signals FS at a predetermined sampling period (for example, a period of 5 seconds) in a predetermined period (for example, 5 minutes), and analyzes the change rate of the fluorescence intensity over time, thereby analyzing the test within the sample. Perform quantitative analysis of substances (rate method). The analysis result is output from the information output means 4 comprising a monitor, a printer or the like.

  Here, in order to perform quantitative analysis with high accuracy by the rate method described above, it is necessary that the sample solution flows at a predetermined flow rate. Since the flow rate of the sample depends on the amount and viscosity of the sample, the analyzer 1 includes a weight measurement unit 60 and a determination unit 70 in order to measure whether or not the analysis can be performed at an appropriate flow rate. Yes.

  The weight measuring unit 60 measures the weight of the sample injected into the test chip 10 and is, for example, a weight sensor (for example, provided in the nozzle holding unit 21 (see FIGS. 4 and 5) in the sample processing unit 20). Strain gauge). Then, the weight measuring means 60 calculates the weight of the nozzle tip NC after the sample solution is aspirated (see FIG. 5) and the weight of the nozzle tip NC after the sample solution is flowed from the nozzle tip NC into the flow path 15. measure. Then, the weight measuring means 60 detects the weight change ΔW before and after the injection as the weight of the sample solution.

  The determination unit 70 in FIG. 2 determines whether or not the amount and viscosity of the sample are within a preset specified range based on the sample weight ΔW measured by the weight measurement unit 60. Here, as shown in FIG. 7, when the sample processing means 20 injects the sample solution into the test chip 10 for a certain period of time and at a constant pressure, the higher the viscosity, the smaller the amount to be injected and the smaller the weight change ΔW. . Therefore, the determination means 70 stores the relationship between the weight change ΔW and the viscosity shown in FIG. 7 and detects the viscosity from the weight change, and determines whether or not the amount and the viscosity of the sample are within a preset specified range. judge. In particular, the determination means 70 stores a lower limit ΔWref of the weight change ΔW as a specified range, and when the weight change ΔW is smaller than the lower limit ΔWref, it is determined that the viscosity is high enough to cause an analysis problem. .

  Although the case where only the lower limit ΔWref is set as the specified range is illustrated, the upper limit, that is, the case where the viscosity is too small may be specified. Further, although the case where the weight measuring unit 60 is provided in the nozzle holding unit 21 is illustrated, the weight measuring unit 60 is attached to a portion where the test chip 10 is placed, and the weight change ΔW of the test chip 10 is measured. In addition, although the case where the weight and the viscosity have a proportional relationship is illustrated in FIG. 7, there may be an exponential function or a power function relationship depending on the type of specimen and the type of reagent. At this time, a relationship such as an exponential function may be stored in the storage table.

  When the determination unit 70 determines that the viscosity is outside the specified range, the sample processing unit 20 performs additional processing so that the sample in the test chip 10 flows at a predetermined flow rate. Specifically, the sample processing means 20 additionally injects a diluent made of physiological saline or the like into the test chip 10. Alternatively, the sample processing means 20 additionally injects the sample and reagent in the sample container CB into the test chip 10. Alternatively, when the weight change ΔW is outside the specified range, the pressure for flowing the sample may be increased or decreased so that the sample flows at a predetermined flow rate.

  In this way, the amount and viscosity of the sample solution injected into the test chip 10 based on the weight can be detected before the start of analysis, and additional processing can be performed on the sample solution that is likely to cause an abnormality. It is possible to prevent the occurrence of abnormality without wasting it. That is, when the development speed when the specimen is developed as in the prior art is measured, the specimen solution already deployed is wasted even if an abnormality is detected. Further, the flow rate of the sample depends not only on the amount of the sample but also on the viscosity, and it is necessary to detect the amount and viscosity of the sample. On the other hand, by detecting the amount and viscosity of the sample based on the weight before the analysis as described above, additional processing is performed on the sample solution that is likely to cause an abnormality, and a sample with an appropriate flow rate can be obtained. can do.

  Furthermore, as shown in FIGS. 4 and 5, the analyzer 1 may have a temperature sensor 61 that detects the temperature of the specimen. The temperature sensor 61 is attached to the nozzle holding unit 21 of the sample processing means 20 and measures the temperature of the sample by the temperature sensor when extracting the sample from the sample container CB. On the other hand, for example, a table (see FIG. 7) showing the relationship between weight and viscosity for each temperature is stored in the determining means 70, and it is determined whether the viscosity is within a specified range based on the temperature and weight. You may do it. Thereby, based on the knowledge that the viscosity, kinematic viscosity, and density of pure water, blood, plasma, and the like differ depending on the temperature, the viscosity can be accurately detected using not only the weight but also the temperature.

  FIG. 8 is a flowchart showing a preferred embodiment of the analysis method of the present invention. The analysis method will be described with reference to FIGS. First, the test chip 10, the sample container CB, and the nozzle chip NC are loaded into the analyzer 1 (step ST1). Then, the sample processing means 20 mixes the sample in the sample container CB and the reagent in the reagent cells 14a and 14b to generate a sample solution (see FIG. 4 and FIG. 5, step ST2).

  Thereafter, the sample solution is injected into the test chip 10 from the nozzle chip NC (step ST3). At this time, the weight measuring means 60 measures the weight of the nozzle tip NC before injection and the weight of the nozzle tip NC after injection, and detects a weight change ΔW (step ST4). In the determination means 70, it is determined whether or not the viscosity (weight change ΔW) is smaller than the set reference value (step ST5). When the viscosity is smaller than the specified range ΔWref, the specimen processing means 20 additionally injects the diluent into the test chip 10. And additional processing such as additional injection of the specimen solution is performed (step ST6).

  Thereafter, the analysis by the data analysis means 50 is started while flowing the sample solution into the flow path 15 (step ST7). A plurality of fluorescent signals are sampled in a predetermined period (for example, 5 minutes) while flowing the sample solution into the flow path 15 of the test chip 10, and quantitative analysis is performed by the rate method (step ST8). In this way, the amount and viscosity of the sample solution injected into the test chip 10 based on the weight can be detected before the test, and an additional process can be performed on the sample solution that is likely to be abnormal before the test is started. Therefore, the occurrence of abnormality can be prevented without wasting the specimen.

  FIGS. 9 to 11 are schematic views showing another embodiment of the test chip used in the analyzer of the present invention. The test chip 110 will be described with reference to FIGS. The test chip 110 of FIGS. 9 and 10 differs from the test chip 10 of FIGS. 2 and 3 in that a test substance is tested using an immunochromatography technique.

  When observing a color reaction by an immunochromatograph as shown in FIGS. 9 and 10, the reading means 40 in FIG. 2 detects the coloration state (lightness / darkness) of the test area TL and the control area CL instead of the fluorescence detection. It will be. The light irradiation means 30 irradiates the observation window 110Z of the test chip 110 with white light for observing the coloration instead of irradiating the excitation light.

  FIG. 9 and FIG. 10 are schematic views showing an example of the test chip 110 read by the analyzer 1. As the test chip 110, a known technique such as JP2009-139256A, JP2007-64766A, or the like can be used. The test chip 110 is a device for performing a quantitative or qualitative (negative / positive) test of a test substance using an immunochromatography method, and labels the test substance (predetermined antigen) so as to be visible. To do. The test chip 110 is spotted with a sample solution in which a sample that may contain a test substance and a labeled substance (second antibody) are mixed.

  The test chip 110 has an upper case 110A, a lower case 110B, and an insoluble carrier 112, and the insoluble carrier 112 is injected into the upper case 110A and the lower case 110B. The upper case 110A is formed with a through hole 111 for spotting the sample solution on the insoluble carrier 112 from the outside and a through hole 114 for spotting the amplification solution on the insoluble carrier 112. On the other hand, an insoluble carrier 112 is fixed to the lower case 110B, and an observation window 110Z for observing quantitative or qualitative measurement of the test substance is formed. In addition, on the surface of the lower case 110B, information storage means 115 such as character information in which identification information (name and the like) of the sample (time information necessary for reaction) and the like are recorded, a barcode, and an IC tag are provided.

  The insoluble carrier 112 is made of an absorbent such as cellulose filter paper, glass fiber, polyurethane, etc., and the spotted sample solution flows in a certain direction due to capillary action. The insoluble carrier 112 is formed with a test area TL and a control area CL. The test region TL includes a first antibody having specificity for a test substance (antibody) fixed in a line (test line), and the first antibody-test substance is determined by the presence of the test substance. -A second antibody conjugate is formed and colored in a line. On the other hand, in the control region CL, a reference antigen (or antibody) that reacts with the labeled antibody is fixed, and reacts with the labeled antibody in the sample solution and is colored in a line. Therefore, by confirming the coloration state of the control region CL, it can be determined whether or not the sample solution has passed over the test region TL and the control region CL.

  Further, the test chip 110 has a cleaning liquid flow path for cleaning the test area TL and the control area CL so as to sandwich the test area TL and the control area CL in the vertical direction (a direction substantially orthogonal to the flow path of the sample solution). The cleaning layers 113a and 113b are formed. The cleaning layers 113a and 113b are made of the same material as the insoluble carrier 112, and a cleaning liquid is stored on the cleaning layer 113a side (not shown). Then, after the reaction in the test region TL and the control region CL is completed, the cleaning layer 113a is pressed from the analyzer 1. Then, the cleaning liquid flows from the cleaning layer 113a to the cleaning layer 113b side by capillary action, and the cleaning liquid flows to the test area TL and the control area CL existing between the cleaning layers 113a and 113b. As a result, the labeled antibody that did not form an immune complex on the test region TL and the control region CL is removed.

  Further, the upper case 110A is formed with a through-hole 114 through which the amplification liquid containing metal ions (silver colloid or the like) is spread on the insoluble carrier 112 from the specimen processing means 20. Then, after the washing with the washing solution, the amplification solution develops on the insoluble carrier 112, whereby the metal ions adhere to the immune complexes on the test region TL and the control region CL, and the colored state is amplified. Note that, as described in Japanese Patent Application No. 2009-222010, for example, it may be determined whether or not the above-described amplification processing is performed according to a color state before amplification.

  FIG. 11 is a schematic diagram showing an example of the sample processing means 120 for automatically spotting a sample solution on the test chip 110 shown in FIGS. As shown in FIG. 11, a test chip 110, a specimen container CB, a container containing a cleaning liquid, and a container containing an amplification liquid are loaded into the analyzer 1. A plurality of nozzle chips (sampler chips) NC for dispensing the sample solution, the washing solution, and the amplification solution are also loaded at the same time. Then, after injecting the sample solution from the sample container CB into the test chip 110 using the nozzle tip, the sample processing means 120 injects the cleaning solution from the container into the cleaning layer 113a in the cleaning step, and the amplification solution from the container in the amplification step. Inject into insoluble carrier 112. Note that the specimen, cleaning liquid, and amplification liquid remaining in the nozzle chip NC between each process are discarded as needed.

  Even when the test chip 110 as shown in FIGS. 9 and 10 is used, the weight measuring means 60 and the determination means 70 determine the amount and viscosity of the sample solution based on the weight change of the test chip 110. That is, the weight measuring unit 60 measures the weight change before and after the sample solution stored in the sample container CB is spotted on the test chip 110 (see FIGS. 4 and 5), and the determination unit 70 is added based on the weight change. It is determined whether or not processing is to be performed (see FIG. 7). Even in an analyzer using an immunochromatograph as described above, the amount and viscosity of the sample solution injected into the test chip 110 based on the weight are detected before the analysis is started, and the sample solution is likely to be abnormal. Since additional processing can be performed, it is possible to prevent an abnormality from occurring without wasting the sample.

  According to each of the above embodiments, in the analysis method for examining the test substance in the sample while flowing the sample through the test chips 10 and 110, the weight ΔW of the sample solution injected into the test chips 10 and 110 is calculated. Based on the measured weight ΔW, it is determined whether or not the amount and viscosity of the sample are within a preset specified range ΔWref, and it is determined that the amount or viscosity of the sample is outside the specified range In this case, the weight of the specimen before the specimen flows into the test chips 10 and 110 is obtained by performing additional processing on the specimen in the test chips 10 and 110 so that the amount or viscosity of the specimen is within the specified range. The viscosity of the specimen is detected from ΔW, it is determined whether or not the examination can be performed without abnormality, and the examination can be performed without abnormality. Therefore, the examination can be performed accurately without wasting the specimen. Ukoto can.

  In addition, when the temperature sensor for detecting the temperature of the specimen is further provided and the determination unit 70 detects the viscosity of the specimen based on the temperature and weight of the specimen, the viscosity of the specimen depends on the temperature. The viscosity of the specimen can be detected with high accuracy.

  Furthermore, if the sample processing means 20 additionally injects a diluent into the sample in the test chip or additionally injects the sample, an abnormality occurs by performing additional processing so that the sample flows at a predetermined flow rate. It is possible to perform a highly accurate inspection without any problems.

  The embodiment of the present invention is not limited to the above embodiment. For example, although FIG. 7 illustrates the case where the sample solution is injected at a constant pressure for a predetermined time, the viscosity may be detected based on the weight when the predetermined volume is injected. In other words, the sample solution of the same volume has a different weight depending on the density. Even in this case, the viscosity of the specimen can be detected based on the change in weight.

  Further, in the above embodiment, the case where addition of a diluent or a sample is performed as an additional process when the viscosity is outside the specified range is illustrated, but in order to control the flow rate of the sample, Changes in pressure and suction pressure, temperature control of the specimen, etc. may be performed.

  Furthermore, although the case where the viscosity is detected based on the weight change ΔW is illustrated, sample injection is started using a sensor unit including a light emitting element and a light receiving element so as to sandwich the flow path 15 in FIG. The time from the measured time to the detection of the sample in the flow path 15 may be measured, and the viscosity of the sample may be detected based on the measured time. Alternatively, the insoluble carrier 112 in FIG. 10 is monitored by an image sensor (reading means 40), and the time when the sample reaches a predetermined position of the insoluble carrier 112 from the time when the injection of the sample is started is measured to detect the viscosity of the sample. May be.

DESCRIPTION OF SYMBOLS 1 Analyzer 10, 110 Test chip 20, 120 Specimen processing means 21 Nozzle holding part 30 Light irradiation means 40 Reaction detection means 50 Data analysis means 60 Weight measurement means 70 Determination means CR, CL Control area TR, TL Test area TR Test area ΔW Weight change ΔWref Specified range

Claims (8)

In an analyzer for analyzing a test substance in a sample while flowing the sample in a test chip,
A weight measuring means for measuring the weight of the sample solution injected into the test chip;
Determining means for determining whether or not the viscosity of the specimen is within a preset specified range based on the weight measured by the weight measuring means;
When the determination unit determines that the viscosity of the sample is out of the specified range, sample processing is performed to perform additional processing on the sample in the test chip so that the viscosity of the sample is within the specified range. An analyzer comprising: means.   The determination means determines whether the viscosity of the sample is within the specified range by comparing the weight of the sample with a preset reference value. Item 1. The analyzer according to Item 1.   The analyzer according to any one of claims 1 and 2, wherein the sample processing means additionally injects a diluent into the sample in the test chip.   The analyzer according to any one of claims 1 to 3, wherein the sample processing means additionally injects the sample into the test chip.   5. The temperature sensor according to claim 1, further comprising a temperature sensor that detects a temperature of the specimen, wherein the determination unit detects the viscosity of the specimen based on the temperature and the weight. The analyzer according to item.   6. The test chip according to claim 1, wherein the test chip has a flow path through which the specimen flows and a test area for capturing the test substance formed in the flow path. The analyzer according to claim 1.   The test chip has an insoluble carrier in which the specimen flows due to capillary action, and a test area that is formed on the insoluble carrier and reacts with a test substance in the specimen to be colored. The analyzer according to any one of 1 to 6. In the analysis method for inspecting the test substance in the sample while flowing the sample through the test chip,
Measure the weight of the specimen injected into the test chip,
It is determined whether the amount and viscosity of the specimen are within a preset specified range based on the measured weight,
When it is determined that the viscosity of the sample is outside the specified range, an additional process is performed on the sample in the test chip so that the viscosity of the sample is within the specified range. Method.

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