JP2001091512A - Blood constituent-analyzing device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood constituent-analyzing device for rapidly measuring a hematocrit value and at the same time easily analyzing a blood constituent where the hematocrit value has been corrected. SOLUTION: A channel consisting of glass fiber filter paper 2, 3, 5, and 11 and an antibody insoluble membrane 9 is formed, potential is applied to an operation electrode 7 and a counter electrode 8, at the same time blood is injected into a specimen introduction part 13, and time when the blood or plasma has reached the counter electrode 8 is measured based on the change in a response current, thus calculating the hematocrit value of blood. Further, a calibration curve or a hematocrit correction expression for each hematocrit value is prepared even in the analysis of a blood constituent and is used to correct influence due to the hematocrit value according to the amount of response current obtained from the operation electrode 7.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component analyzer, and more particularly to a blood component analyzer capable of measuring a hematocrit value.
The present invention relates to a blood component analyzer that can correct the influence of a hematocrit value in measuring a predetermined blood component.

[0002]

2. Description of the Related Art With the recent advance of medical technology, there is a demand for faster and simpler measurements in clinical examination sites.
In general, blood tests are often performed by centrifuging blood and analyzing the resulting plasma or serum.
For the sake of simplicity, an analyzer that does not require a complicated operation such as centrifugation has been studied.

However, since it is very important to separate plasma or serum from blood in order to perform an accurate analysis, the blood is filtered to eliminate blood cell components by incorporating glass fiber filter paper in the analyzer. Means for doing so are often used. This method is described in, for example,
This has already been reported in Japanese Patent No. 64539 and Japanese Patent Application Laid-Open No. 8-54387.

Further, as disclosed in Japanese Patent Application Laid-Open No. H10-177026, the present inventors have already proposed an analyzer capable of quickly and simply measuring a blood sample. In this conventional analyzer, when blood is added, the blood cell component is eliminated by filtration, and the concentration of the target substance to be measured in the plasma component can be electrochemically detected using an antigen-antibody reaction. Includes possible structures.

Here, when separating plasma or serum using glass fiber filter paper, it is necessary to pay attention to the hematocrit value of blood. This is because blood cells are clogged during separation of plasma or serum in glass fiber filter paper.
Naturally, this clogging is more likely to occur in blood with a higher hematocrit value. Human hematocrit values are distributed in the range of about 35 to 55% depending on age, gender, etc. As a measuring method, a capillary cell and a centrifuge are used to measure blood cell components and liquid components in blood. There are known a method of obtaining from a volume ratio, a method of obtaining from the electrical resistance of blood, a method of obtaining from the number of blood cells in a unit volume and an average blood cell volume, and the like.

As a method of developing a blood sample, a flow-through method and a lateral flow method are generally used.
Here, a flow path is formed by stacking two or more porous filters to form a flow path, and a blood sample is developed vertically to the porous filters by arranging one or more porous filters. A method of forming a flow path and developing a blood sample in parallel with a porous filter is referred to as a lateral flow method. Furthermore, as a method combining a flow-through method and a lateral flow method, a method is disclosed in which a flow path is formed by combining two or more porous filters, and a blood sample is developed vertically and parallel to the porous filters. You.

[0007]

However, in the above-mentioned conventional blood component analyzer, in order to perform an accurate measurement, a predetermined operation for performing the measurement is performed after a certain time from the addition of the blood sample. It is necessary for the user, and the time is limited for general users, so that the operability is poor.

Further, in the conventional blood component analyzer, the permeation rate of blood changes depending on the hematocrit value, thereby changing the amount of antigen-antibody reaction and the response current value, and as a result, the calibration curve also fluctuates. There was a problem. To solve this problem, first create a calibration curve for each hematocrit value, or prepare a correction formula corresponding to the hematocrit value, and then measure the hematocrit value of the blood sample beforehand for measurement. It was necessary to introduce the obtained current value into a calibration curve corresponding to the hematocrit value, or to input the current value into a correction formula to correct the measured value. However, the existing method for measuring a hematocrit value as described above has a problem that a rapid measurement of a hematocrit value cannot be performed.

[0009] In addition, all of the existing methods for measuring hematocrit require a dedicated measuring device separate from a measuring device for measuring the concentration of a predetermined substance to be measured in a plasma component. In addition, since it is necessary to measure the hematocrit value with these measuring devices for each measurement, there is a problem in that the simplicity which is a merit of the analyzing device is lost.

The present invention has been made in order to solve such a problem, and does not require time-limited operation after adding a blood sample without being restricted by time.
To provide a so-called auto-start blood component analyzer, to provide a blood component analyzer that can quickly measure a hematocrit value, and to easily perform a blood component analysis with a corrected hematocrit value. The purpose is to provide.

[0011]

According to a first aspect of the present invention, there is provided a blood component analyzer, comprising: a sample introduction portion into which a blood sample is injected; and a blood cell component in the blood sample. A blood component analyzer comprising a flow path comprising a porous filter that captures a blood sample, and a detection site for detecting that the blood sample has arrived, and measuring and outputting a predetermined analyte concentration in the blood sample. A hematocrit value in the blood sample is obtained from a result of measuring an arrival time from when the blood sample is injected into the sample introduction section to when the blood sample reaches the detection site. As a result, the hematocrit value in the blood sample is determined from the result of the arrival time obtained by measuring the time from when the blood sample is added to the sample introduction section to when the blood sample reaches the detection site, and the hematocrit value in the blood sample is used. The analyte concentration can be calculated.

A blood component analyzer according to a second aspect of the present invention is the blood component analyzer according to the first aspect, further comprising a sample sensing unit for detecting that the blood sample has passed. . Thus, the time required for the blood sample to reach the detection site from the sample sensing unit is measured, and the time required for the blood sample to reach the detection site from the sample introduction unit to the detection site is calculated. The hematocrit value in the sample is obtained, and the test substance concentration can be calculated using the obtained hematocrit value.

A blood component analyzer according to a third aspect of the present invention is the blood component analyzer according to the second aspect, wherein the sample sensing unit is provided between the sample introduction unit and the detection site. It is characterized by becoming. Thus, the time required for the blood sample to reach the detection site from the sample sensing unit can be measured, and the time required for the blood sample to reach the detection site from the sample introduction unit can be calculated from the measurement result.

A blood component analyzer according to a fourth aspect of the present invention is the blood component analyzer according to the second aspect, wherein the sample sensing unit is provided in the sample introduction unit. This makes it possible to sense the time when the blood sample is added to the sample introduction section and measure the time required for the blood sample to reach the detection site from the sample introduction section.

A blood component analyzer according to a fifth aspect of the present invention is the blood component analyzer according to any one of the second to fourth aspects, wherein the specimen sensing unit and the detection site are at least any one of them. Either one is detected by an electrode. Thus, the passage or arrival of the blood sample can be detected by the electrode, the time required for the blood sample to reach the detection site from the sample sensing unit is measured, and the time required for the blood sample to reach the detection site from the sample introduction unit. Can be calculated.

A blood component analyzer according to a sixth aspect of the present invention is the blood component analyzer according to any one of the second to fifth aspects, wherein the specimen sensing unit and the detection site are at least any one of them. Either one detects an electrochemical signal generated by contact of the blood sample with the redox substance or the electrolyte component previously carried on the sample sensing unit or upstream thereof. . Thereby, by detecting an electrochemical signal generated by the contact between the redox substance or the electrolyte component and the blood sample, the time required for the blood sample to reach the detection site from the sample sensing unit is measured, The arrival time of the sample from the sample introduction part to the detection site can be calculated.

The blood component analyzer according to claim 7 of the present invention is the blood component analyzer according to claim 1, wherein the measuring means has a calibration curve or hematocrit correction formula corresponding to each hematocrit value. According to the hematocrit value in the sample obtained from the arrival time, by selecting the calibration curve or using the correction formula, to output the measurement result of the test substance concentration corrected for the influence of the hematocrit value It is characterized by. Thereby, the influence of the hematocrit value in the sample obtained from the arrival time can be corrected, and the analyte concentration can be calculated.

The blood component analyzer according to claim 8 of the present invention is the blood component analyzer according to any one of claims 1 to 7, wherein the analyte concentration is measured at the detection site. It is characterized by. Thus, the concentration of the test substance in the blood sample can be measured at the detection site.

A blood component analyzer according to a ninth aspect of the present invention is the blood component analyzer according to the eighth aspect, wherein the means for measuring the concentration of a predetermined test substance in the blood sample is an antigen-antibody reaction. As a means for detecting the amount of antigen-antibody reaction, the method is characterized in that the antigen or antibody is labeled with an enzyme, and the amount of the enzyme reaction is electrochemically detected via a redox substance. As a result, an oxidation-reduction reaction between the enzyme and the substrate of the antigen-antibody complex labeled with the enzyme occurs. The current generated at that time is detected to determine the amount of current, and the amount of enzyme reaction can be calculated from the amount of current.

[0020]

Embodiments of the present invention will be described below with reference to the drawings. The embodiment described here is merely an example, and the present invention is not necessarily limited to this embodiment.

(Embodiment 1) Hereinafter, a blood component analyzer according to Embodiment 1 of the present invention will be described with reference to the drawings. The blood component analyzer according to the first embodiment of the present invention includes a sample introduction unit into which a blood sample is injected, a flow path including a porous filter that captures blood cell components in the blood sample, and a blood sample that reaches the blood sample. A blood component analyzer that measures and outputs a predetermined analyte concentration in the blood sample, wherein the blood sample is injected into the sample introduction unit and then to the detection site. The hematocrit value in the blood sample is determined from the result of measuring the time to reach.

The material constituting this flow path has a pore diameter of 10 μm.
The following porous member, or preferably contains a filter capable of capturing red blood cells, for example, glass fiber filter paper, nitrocellulose membrane, cellulose filter paper,
Non-woven fabrics, synthetic fibers and the like are mentioned as porous filters.

At least one of the sample sensing portion and the detection site is detected by an electrode, and an example of the detection means is an electrochemical detection method.

The blood component analyzer further comprises a measuring means for measuring a predetermined concentration of a test substance in the blood sample injected from the sample introducing section, and the measuring means corresponds to each hematocrit value. A calibration curve or hematocrit correction formula, and a test in which the influence of the hematocrit value is corrected by selecting the calibration curve or using the correction formula according to the hematocrit value in the sample obtained from the arrival time. This is to output the measurement result of the substance concentration. As a means for measuring the concentration of the test substance, a means for electrochemically detecting a specific binding reaction such as an antigen-antibody reaction or an enzymatic reaction to detect the concentration is exemplified.

Hereinafter, the configuration of the blood component analyzer according to the first embodiment will be described. FIG. 1 is an exploded perspective view showing a blood component analyzer according to the present invention. In FIG. 1, a sample introduction unit 13 for injecting a blood sample is provided on the upper surface of the upper case 1. Reference numeral 2 denotes a blood spreading layer, which is exemplified by a porous member such as a glass fiber filter paper having a pore size of 10 μm or more or a pore size not catching blood cells. Reference numeral 3 denotes a reagent obtained by impregnating a glass fiber filter with an enzyme-labeled antibody obtained by labeling a target substance in a test solution, for example, an antibody specifically binding to an antigen with an enzyme, a buffer solution component, and an electron mediator, and then drying Layer. Reference numeral 5 denotes a reaction layer made of glass fiber filter paper containing a buffer component and the like. Examples of the materials 3 and 5 include, besides glass fiber filter paper, a porous member having a pore diameter of 10 μm or less or capable of capturing red blood cells. 4
Is a solution impermeable seal provided between the reagent layer 3 and the reaction layer 5. Reference numeral 6 designates a PET port formed with a passage 14 for a test liquid at the center thereof and a pattern of a working electrode 7 and a counter electrode 8 formed on the lower surface by screen printing using carbon or silver as a conductive substance. It is an electrode substrate. One end of this electrode substrate protrudes from the side surface of the upper case 1,
In order to measure the amount of current between the working electrode 7 and the counter electrode 8, it can be connected to an external measuring device. The working electrode 7 and the counter electrode 8 are combined as a detection site, and a measuring means for measuring a predetermined analyte concentration in the blood sample injected from the sample introduction portion is provided. By applying a potential between the current and the current, a current proportional to the amount of the enzyme reaction flows, and the amount of the antigen in the test solution can be measured based on the current value. Reference numeral 9 denotes a porous membrane made of a material such as nitrocellulose, and an antibody to the enzyme-labeled antibody was immobilized on the surface of the porous membrane to obtain an antibody-insoluble membrane. This antibody is fixed so as not to be dissolved even when infiltrated into a test solution such as serum or plasma. Reference numeral 11 denotes a substrate layer made of filter paper which has been impregnated with an enzyme substrate and dried, and examples thereof include glass fiber filter paper having high water absorption. 10
Is a semipermeable seal such as a dialysis membrane adhered between the antibody-insolubilized membrane 9 and the substrate layer 11, and allows the passage of the enzyme substrate but does not allow the passage of the antigen labeled with the enzyme-labeled antibody.

FIG. 2 is a cross-sectional view showing the structure of the blood component analyzer according to Embodiment 1 of the present invention. In the drawing, the same reference numerals as those in FIG. 1 denote the same or corresponding parts. By bonding the above components to the upper case 1 and the lower case 12 made of resin, a certain pressure is applied, so that the components can be installed without displacement.

Next, a measuring method will be described. First, when a blood sample serving as a test liquid is injected from the sample introduction unit 13 of the upper case 1, the sample enters the reagent layer 3 via the blood development layer 2 and flows into the reaction layer 5 while dissolving the components of the reagent layer 3. . In the reaction layer 5, the enzyme-labeled antibody, which is a reagent composition, and the antigen in the test solution cause specific binding. At this time, since the test solution flows to the reaction layer 5 bypassing the solution-impermeable seal 4, all antigens in the test solution to be quantified can react with the enzyme-labeled antibody. .

When the test liquid flows through the antibody-insolubilized membrane 9 from the passage port 14, the enzyme-labeled antibody specifically bound to the antigen binds to the antibody immobilized on the surface of the antibody-insolubilized membrane 9. The test liquid bypasses the semi-permeable seal 10 and spreads over the entire surface of the antibody-insolubilized membrane 9 to promote binding, and sufficiently wets the substrate layer 11.

The test solution dissolves the enzyme substrate in the substrate layer 11, and the enzyme substrate passes through the semi-permeable seal 10 without bypass and reaches the electrode substrate 6 again. Then, an enzyme reaction between the enzyme of the enzyme-labeled antibody specifically bound to the insolubilized antibody and the dissolved substrate initiates an enzymatic reaction, thereby causing an oxidation-reduction reaction of the electron transfer substance. At this time, the working electrode 7 and the counter electrode 8 When a potential is applied, a current proportional to the amount of the enzyme reaction flows. From this current value, the amount of antigen in the test solution can be measured.

In this blood component analyzer,
Since glass fiber filter paper is used as the reagent layer 3 and the reaction layer 5, blood cells in blood are clogged in this portion,
The permeation rate decreases. This permeation rate further decreases as the amount of hematocrit in the blood increases. That is,
When the amount of hematocrit in the blood increases, the time from the start of blood injection to the first generation of a response current at the working electrode 7 and the counter electrode 8 also becomes slow. The time between the start of blood infusion and the generation of the first response current is measured, and based on this, the time between the start of blood infusion and the generation of the first response current is proportional to the hematocrit value in the blood. Ask for a relationship. Then, by measuring the time from the start of the injection of the blood sample to be actually measured to the time when the first response current is generated, and applying this measurement result to the above proportional relationship, it is possible to obtain the hematocrit amount in the blood sample. it can.

Here, the amount of antigen in the test solution measured from the amount of response current flowing through the working electrode 7 and the counter electrode 8 is affected by the amount of hematocrit because the penetration rate of the sample changes depending on the amount of hematocrit. It is necessary to correct the measured value by the amount. Therefore, in the first embodiment, a plurality of calibration curves for obtaining the analyte concentration, for example, the amount of the antigen from the current value of the response current are prepared in advance in accordance with each hematocrit value, and the injection of the sample is started. By selecting one of the plurality of calibration curves corresponding to the hematocrit amount obtained from the time until the first response current is generated from the above, and obtaining the analyte concentration from the current value of the response current using this calibration curve. To obtain a test substance concentration corrected for the influence of the amount of hematocrit.

Although a plurality of calibration curves are prepared in accordance with the amount of hematocrit here, the measurement results of the amount of the response current flowing through the working electrode 7 and the counter electrode 8 according to the amount of hematocrit are prepared. A correction formula for correction may be prepared, and the measurement result of the current amount of the response current may be corrected based on the measurement result of the hematocrit amount using the correction formula.

As described above, according to the blood analyzer of the first embodiment, the flow path composed of the sample introduction part into which the blood sample is injected and the porous filter for capturing blood cell components in the blood sample. And a detection site for detecting that the blood sample has arrived, and a blood component analyzer for measuring and outputting a predetermined analyte concentration in the blood sample, wherein the blood sample is injected into the sample introduction section. Since the hematocrit value in the blood sample was determined from the result of measuring the time to reach the detection site from the time, the blood sample was added to the sample introduction unit and reached the detection site. The hematocrit value can be obtained from the result of the arrival time obtained by measuring the time, and the test substance concentration can be calculated using the obtained hematocrit value.

The blood sample injected from the sample introduction section is provided with a measuring means for measuring a predetermined analyte concentration, and the measuring means comprises a calibration curve or a hematocrit correction corresponding to each hematocrit value. Having the formula, according to the hematocrit value in the sample obtained from the arrival time, by selecting the calibration curve or using the correction formula, the measurement result of the test substance concentration corrected for the effect of the hematocrit value Output, it is possible to accurately measure the target analyte concentration, unlike the conventional, it is not necessary to measure the hematocrit value and the predetermined analyte concentration in separate devices, A blood component analyzer excellent in simplicity can be provided.

As a means for measuring the concentration of a predetermined test substance in the blood sample, an antigen-antibody reaction is used. As a means for detecting the amount of the antigen-antibody reaction, an antigen or antibody is labeled with an enzyme, and the enzyme reaction is performed. Since the amount is electrochemically detected via a redox substance, an oxidation-reduction reaction between the enzyme and the substrate of the antigen-antibody complex labeled with the enzyme occurs, and the current generated at that time is detected to determine the amount of current. The enzyme reaction amount can be calculated from the obtained current amount.

(Embodiment 2) A blood component analyzer according to Embodiment 2 will be described below with reference to the drawings.
The blood analyzer according to the second embodiment of the present invention can automatically detect the addition of a blood sample by providing a sample sensor in the upper case in the blood component analyzer described in the first embodiment. It is like that. Note that the second embodiment is implemented in a form added to the first embodiment, and therefore, description of parts common to the first embodiment is omitted.

FIG. 5 is a bottom view of upper case 1 of the blood component analyzer shown in the first embodiment. In FIG.
Reference numeral 15 denotes a sample sensing electrode, and 16 denotes a sample sensing counter electrode. The sample sensing electrode 15 and the sample sensing counter electrode 16 are combined to form a sample sensing unit. In FIG. 5, the same reference numerals are used for the same or corresponding components as those in FIG.
The description is omitted.

The sample sensing electrode 15 and the sample sensing counter electrode 1 are provided on the lower surface of the upper case 1 along the peripheral portion of the sample introduction section 13.
6 is installed. Both the sample sensing electrode 15 and the sample sensing counter electrode 16 can be connected to an external device by extending the lead portion to the side surface of the upper case 1. By supporting an oxidation-reduction substance or an electrolyte on the blood spreading layer 2 and applying a potential between the sample sensing electrode 15 and the sample sensing counter electrode 16, an electrical signal can be sensed when a sample is added. Become. In addition, since an electric signal is similarly obtained when the blood sample reaches the detection site, it is possible to automatically detect the time until blood reaches the detection site from the sample sensing unit. In the second embodiment,
Although the sample sensing unit is provided in the sample introduction unit, it may be installed between the sample introduction unit and the detection site.

As described above, according to the blood component analyzer according to the second embodiment, the sample introduction unit is provided with the sample sensing unit for detecting that the blood sample has passed, so that the blood sample analyzer is automatically operated when the blood sample is added. Since the blood sample can be sensed, it is possible to measure the time required for the blood sample to reach the detection site from the sample introduction part, determine the hematocrit value in the blood sample from the measurement result, and use the obtained hematocrit value. The analyte concentration can be calculated.

Further, the sample sensing section and the detection section detect the electrochemical signal generated by the contact with the redox substance or the electrolyte component carried in advance on the sample sensing section or upstream thereof, thereby detecting the sample. The time from the sensing unit to the detection site is measured, and the arrival time from the sample introduction unit to the detection site can be calculated from the measurement result.

[0041]

Next, an embodiment of the present invention will be described based on Embodiment 1. (a) Manufacturing method of member Upper case 1, lower case 12 Molded product made of ABS resin.

Blood development layer 2 Glass fiber filter paper was cut to 11 mmφ.

Reagent layer 3 8 mM N, N, N ', N'-tetrakis- (2-hydroxyethyl) -p-phenylenediamine (abbreviation: THE
PD) /2.5% normal rabbit serum (abbreviation: NRS) / 5%
Lactose / 50mM NaCl / 25mMPIPES
(PH 7.4) / 80 U / ml heparin, HR
A diluted solution of PO-labeled CRP was prepared. Add this diluted solution to 1
120 μl was spotted on a surfactant-treated glass fiber filter paper cut to 1 mmφ, frozen with liquid nitrogen, and freeze-dried.

Solution-impermeable seal 4 A polyethylene terephthalate (abbreviated as PE) having a thickness of 40 μm
T) The seal made was cut to 7 mmφ.

Reaction layer 5 30 mM NaN3 / 10 mM PIPES (pH 7.4)
/ 160 U / ml heparin solution was cut to 11 mmφ and added to a surfactant-treated glass fiber filter paper.
μl was spotted, frozen with liquid nitrogen, and lyophilized.

Electrode 6 An inner diameter of 4 mmφ and an outer diameter of 6 mmφ were placed on a PET having a thickness of 250 μm.
Was screen-printed with carbon in the form of a ring to form a working electrode. Further, silver was screen-printed in a ring shape having an inner diameter of 8.5 mmφ and an outer diameter of 9.5 mmφ to form a counter electrode. Furthermore, the inside of the working electrode is cut into a circular shape of 3.8 mmφ,
An electrode was used.

The antibody insolubilized membrane 9 was prepared using phosphate buffered saline (abbreviation: PBS).
15 mg / ml anti-CRP monoclonal antibody / 1.85
mg / mL bovine gamma globulin / 1% ethanol solution
20 μl of a 5 mmφ ring was spotted on the mixed cellulose membrane cut to 10 mmφ. This was dried for 1 hour, immersed in 1% casein / PBS solution for 30 minutes and shaken, washed with PBS three times, and dried to obtain an antibody-insoluble membrane.

Semi-permeable seal 10 A dialysis membrane made of α-cellulose was cut to 8 mmφ.

Substrate layer 11 50 mM hydrogen peroxide / 100 mM hydantoic acid (pH
6.0) / 20 mM potassium guaiacol sulphonate / 2 mg / 160 U / ml heparin solution
75 μl was spotted on a glass fiber filter paper cut to φ, frozen with liquid nitrogen, and freeze-dried.

(B) Assembly of the member A double-sided tape cut to 10 mmφ was attached to the lower case, and the substrate layer was placed thereon. Further, a semi-permeable seal, an antibody-insolubilized membrane, an electrode, a reaction layer, a solution-impermeable seal, a reagent layer, and a blood development layer were sequentially laminated as shown in FIG. 1 and covered with an upper case to form an analyzer.

(C) Measurement of hematocrit value The hematocrit value of fresh blood was measured by using a capillary and a centrifuge to determine the volume ratio of blood cell components to plasma components. Further, a sample whose hematocrit value was adjusted to 35%, 40%, 45%, 50%, and 55% by adding and extracting plasma components was prepared.

(D) Measurement The analyzer assembled as described above was connected to a current measuring device, and 220 μl of blood to which CRP was added was injected, and at the same time, a potential of −150 mV was applied to the working electrode. After blood injection, the time at which a current response first occurred was measured, and the time at which blood reached the detection site was defined as the time. 42 from blood injection
The average current value after 0 to 480 seconds was measured and defined as a response current value.

(E) Results FIG. 3 shows the response current value at each hematocrit value. The response current value fluctuated due to the hematocrit value. FIG. 4 shows the time from the injection of blood into the sample introduction part to the arrival at the detection site. The higher the hematocrit, the longer the time for blood to reach the detection site.

[0054]

As described above, according to the blood component analyzer according to the first aspect of the present invention, the sample introduction portion into which the blood sample is injected, and the porous portion for capturing the blood cell component in the blood sample. A blood component analyzer that includes a flow path composed of a filter and a detection site that detects that the blood sample has arrived, and that measures and outputs a predetermined analyte concentration in the blood sample,
Since the hematocrit value in the blood sample was determined from the result of measuring the time from when the blood sample was injected into the sample introduction portion to when the blood sample reached the detection site, the blood sample was transferred to the sample introduction portion. The hematocrit value in the blood sample is obtained from the result of the arrival time obtained by measuring the time from the addition to the detection site, and the concentration of the test substance can be calculated using the obtained hematocrit value.

According to the blood component analyzer of the second to fourth aspects of the present invention, since the blood sample is provided with the sample sensor for detecting that the blood sample has passed, the blood sample can be detected by the sample sensor. The time required to reach the detection site was measured, the arrival time of the blood sample from the sample introduction part to the detection site was calculated from the measurement result, and the hematocrit value in the blood sample was obtained from the arrival time, and the obtained value was obtained. The test substance concentration can be calculated using the hematocrit value.

According to the blood component analyzer of the fifth aspect of the present invention, at least one of the sample sensing portion and the detection site is detected by the electrode, so that the blood sample passes or reaches. This can be detected by the electrode, the time required for the blood sample to reach the detection site from the sample sensing unit can be measured, and the time required for the blood sample to reach the detection site from the sample introduction unit can be calculated.

According to the blood component analyzer of the sixth aspect of the present invention, at least one of the sample sensing unit and the detection site is oxidized in advance and is carried on the sample sensing unit or upstream thereof. Since the electrochemical signal generated by the contact between the reducing substance or the electrolyte component and the blood sample is detected, the electrochemical signal generated by the contact between the redox substance or the electrolyte component and the blood sample is detected. By doing so, the time required for the blood sample to reach the detection site from the sample sensing unit can be measured, and the time required for the blood sample to reach the detection site from the sample introduction unit can be calculated.

According to the blood component analyzer of the present invention, the measuring means has a calibration curve or a hematocrit correction formula corresponding to each hematocrit value, and the hematocrit in the sample obtained from the arrival time. Depending on the value, by selecting the above calibration curve or using the above correction formula, the measurement result of the concentration of the test substance corrected for the influence of the hematocrit value is output. The effect of the hematocrit value can be corrected, and the concentration of the test substance can be calculated.

According to the blood component analyzer of the present invention, since the concentration of the test substance is measured at the detection site, the concentration of the test substance in the blood sample can be measured at the detection site.

According to the blood component analyzer of the ninth aspect of the present invention, an antigen-antibody reaction is used as a means for measuring the concentration of a predetermined test substance in the blood sample, and the amount of the antigen-antibody reaction is detected. As a means to perform this, the antigen or antibody is labeled with an enzyme, and the amount of the enzyme reaction is electrochemically detected via a redox substance. A reduction reaction occurs, and a current generated at that time is detected to obtain a current amount, and the enzyme reaction amount can be calculated from the current amount.

[Brief description of the drawings]

FIG. 1 is an exploded perspective view showing a configuration of a blood component analyzer according to Embodiment 1 of the present invention.

FIG. 2 is a cross-sectional view showing the configuration of the blood component analyzer according to Embodiment 1 of the present invention.

FIG. 3 is a diagram for explaining an influence of a hematocrit value in a measurement using the blood component analyzer according to the embodiment of the present invention.

FIG. 4 is a diagram showing a correlation between a time at which blood reaches a detection site and a hematocrit value of blood in the blood component analyzer according to the embodiment of the present invention.

FIG. 5 is a bottom view of an upper case of the blood component analyzer according to Embodiment 2 of the present invention.

[Description of Signs] 1 upper case 2 blood development layer 3 reagent layer 4 solution impermeable seal 5 reaction layer 6 electrode substrate 7 working electrode 8 counter electrode 9 antibody insolubilized membrane 10 semipermeable seal 11 substrate layer 12 lower case 13 sample Introduction part 14 Passage port 15 Sample sensing electrode 16 Sample sensing counter electrode

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) G01N 27/30 353J

Claims (9)

[Claims] 1. A sample introduction unit into which a blood sample is injected, a flow path comprising a porous filter for capturing blood cell components in the blood sample, and a detection site for detecting that the blood sample has arrived. A blood component analyzer for measuring and outputting a predetermined analyte concentration in the blood sample, wherein a result of measuring an arrival time from when the blood sample is injected into the sample introduction section to when the blood sample reaches the detection site is obtained. A hematocrit value in the blood sample from the blood component analyzer. 2. The blood component analyzer according to claim 1, further comprising: a sample sensing unit that detects that the blood sample has passed. 3. The blood component analyzer according to claim 2, wherein the sample sensing unit is provided between the sample introduction unit and the detection site. 4. The blood component analyzer according to claim 2, wherein the sample sensing unit is provided in the sample introduction unit. 5. The blood component analyzer according to claim 2, wherein at least one of the sample sensing unit and the detection site is detected by an electrode. A blood component analyzer. 6. The blood component analyzer according to claim 2, wherein at least one of the sample sensing unit and the detection site is provided in advance at the sample sensing unit or upstream thereof. A blood component analyzer for detecting an electrochemical signal generated by contact of the carried redox substance or electrolyte component with the blood sample. 7. The blood component analyzer according to claim 1, wherein the measuring means has a calibration curve or a hematocrit correction formula corresponding to each hematocrit value, and calculates the hematocrit value in the sample obtained from the arrival time. A blood component analyzer that outputs a measurement result of a test substance concentration in which the influence of a hematocrit value is corrected by selecting the calibration curve or using the correction formula in response to the selection. 8. The blood component analyzer according to claim 1, wherein the test substance concentration is measured at the detection site. 9. The blood component analyzer according to claim 8, wherein the means for measuring a predetermined analyte concentration in the blood sample uses an antigen-antibody reaction to detect the amount of the antigen-antibody reaction. A blood component analyzer, comprising: labeling an antigen or an antibody with an enzyme; and electrochemically detecting the amount of the enzyme reaction via a redox substance.