JPH11304799A - Reagent sampling shortage detection mechanism in whole blood globule immunity measuring device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent an erroneous measurement while the amount of reagent is in shortage by utilizing a flow photometry cell for measuring the immunity of a whole blood globule immunity measuring device and detecting that the total amount (amount of a reaction liquid) of a reagent for measuring immunity being accommodated in a sample reception cell and a whole blood sample is equal to or less than a set value. SOLUTION: A flow photometry cell 20 for measuring immunity is connected to a sample reception cell 29, and constant pouring equipment 23 for moving liquid is connected to the channel at the exit side of the flow photometry cell 20 via a three- way solenoid valve 12b. Then, setting is made so that an end Q of the reaction liquid is located at the upstream side of the flow photometry cell 20 when the constant pouring equipment 23 slides to a stroke end and the reaction liquid is moved forward while a specific amount of reaction liquid is accommodated in the sample reception cell. While the reaction liquid is decreased to a setting value or less, the end of the reaction liquid reaches the flow photometry cell 20 and the end of the reaction liquid is detected by a light application part 20a and a light detection part 20b of the flow photometry cell 20, thus detecting the shortage in reagent sampling.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention includes an immunoassay section for performing an immunoassay and a blood cell count and a measurement section for performing a blood cell count measurement. The present invention relates to a reagent sampling shortage detection mechanism in a whole blood blood cell immunoassay apparatus that is corrected using a hematocrit value obtained by a blood cell count measurement.

[0002]

2. Description of the Related Art There is an inflammatory marker as a technique for observing the presence, degree, and progress of inflammation occurring in the body.
Representative of this inflammation marker are white blood cell count,
There are blood sedimentation value, acute phase protein, serum protein fractionation value, serum sialic acid, and the like, and these are measured in combination to help diagnose inflammation. Among them, measurement of leukocyte count and C-reactive protein (CRP), which is an acute phase protein, is particularly useful for diagnosis of inflammation and infectious disease. The blood cell counter was measured individually, and the latter was measured individually using an immunoassay device.

However, when the measurement is performed individually using the above-mentioned blood cell counter and immunoassay device, the sample (specimen) used for the measurement is whole blood in the former, and is mainly serum in the latter. When obtaining whole blood as a specimen, it is necessary to separately collect blood in a state containing an anticoagulant and in a state without the anticoagulant, while the serum needs to wait for blood coagulation and perform centrifugation. Is not suitable for facilities that cannot always have a specialized laboratory technician, such as small clinics and clinics, remote clinics, holiday clinics, and emergency laboratories.

[0004] On the other hand, there is an immunoassay apparatus that can measure whole blood, but when whole blood is used as a sample, the target immunoassay is not present in blood cells, but only in serum / plasma. In addition, an error occurs due to a variation in the hematocrit value having a relatively large individual difference.

[0005]

The above-mentioned whole blood blood cell immunoassay apparatus has been researched and developed by the present inventors to solve such problems of the prior art, and has already been disclosed in Japanese Patent Application No. 9-279.
No. 963. The whole blood cell immunoassay has the following advantages. Since the result of the immunoassay is corrected using the hematocrit value obtained by the blood cell count measurement, an accurate immunoassay is possible even though whole blood is used as the sample. Since blood cell counting and measurement of immunity parameters can be performed simultaneously with whole blood, specimens need only be handled with whole blood, and there is no need for serum separation, and measurement can be started shortly after blood collection.
The measurement can be easily performed even by a non-specialized inspection technician. As a result of the above, it is particularly useful for emergency and early diagnosis of inflammation and infectious diseases, as well as small clinics and clinics, remote clinics, holiday clinics, emergency laboratories, etc.
A desired inspection can be performed. The probe unit, calculation / control unit, display / output device, etc. can be used in common for blood cell count measurement and immunoassay. Can be achieved.

The present invention is a further improvement of the whole blood blood cell immunoassay apparatus described above, and uses a flow photometric cell used for immunoassay for an immunoassay contained in a sample receiving cell. By detecting that the total volume of the reagent and the whole blood sample (the volume of the reaction solution) has fallen below the set value,
It is an object of the present invention to provide a reagent sampling shortage detection mechanism capable of preventing erroneous measurement in a state where the amount of reagent is insufficient.

[0007]

In order to solve the above-mentioned problems, the present invention comprises an immunoassay section for performing an immunoassay and a blood cell count and a measurement section for performing a blood cell count measurement. A sample receiving cell containing a reagent for immunoassay and a whole blood sample in a whole blood blood cell immunoassay apparatus that uses a sample and corrects the result of the immunoassay using the hematocrit value obtained by blood count measurement. A flow metering cell for immunoassay is connected to the bottom of the cell via a flow path, and a dispenser for liquid transfer is connected to a flow path on the outlet side of the flow metering cell via a three-way solenoid valve, and a sample receiving cell is connected. In a state in which a predetermined amount of the reaction solution is contained,
When the dispenser slides to the end of the stroke and moves the reaction solution in the sample receiving cell forward, the tail of the reaction solution in the flow path is set to be located upstream of the flow metering cell. However, when the reaction solution in the sample receiving cell is reduced below the set value, the end of the reaction solution reaches the flow photometer cell, and the reaction solution is irradiated between the light irradiation unit and the light detection unit of the flow photometer cell. Insufficient sampling of the reagent is detected by detecting the tail of the sample.

According to the reagent sampling shortage detecting mechanism having the above-described structure, when a predetermined amount of a reaction solution (a reagent for immunoassay and a whole blood sample) is contained in the sample receiving cell, the three-way solenoid valve is operated by flow metering. In a state where the cell and the infusion device for liquid transfer are in communication with each other, when the infusion device slides to the stroke end and moves the reaction solution in the sample receiving cell forward,
Since the tail of the reaction solution in the flow path is located upstream of the flow photometer cell, the light irradiation unit and the light detection unit of the flow photometer cell do not detect the tail of the reaction solution.

When the reagent and the whole blood sample are sampled without noticing the lack of the reagent, the amount of the reaction solution (the total amount of the immunoassay reagent and the whole blood sample) contained in the sample receiving cell decreases. Therefore, when the volume is below a certain level, when the liquid transfer injector slides to the stroke end to move the reaction solution in the sample receiving cell forward, The end of the liquid reaches the inside of the flow metering cell.

As a result, air bubbles enter the light beam irradiated to the flow photometer cell, and the light detection section detects air and emits an abnormal signal, so that the tail of the reaction solution is detected, and as a result, the reagent Insufficient sampling will be detected.

In particular, according to the above configuration, the light irradiating section and the light detecting section of the flow photometric cell used for the immunoassay are also used as a sensor for detecting the tail of the reaction solution. The sensor and its installation space are not required, the number of members can be reduced, and the device configuration can be made compact and simple.

In a state in which a predetermined amount of the reaction solution is contained in the sample receiving cell, the dispenser slides to the stroke end to remove the reaction solution in the sample receiving cell. When moved forward, if the tail of the reaction solution in the flow path is set so as to be located near the entrance of the flow photometric cell,
Even if the liquid volume is slightly reduced, when the infusion device slides to the end of the stroke, the tail of the reaction liquid reaches the inside of the flow photometric cell, and the detection accuracy is improved.

[0013]

Embodiments of the present invention will be described with reference to the drawings. FIGS. 1 to 8 show an example of a whole blood cell immunoassay apparatus employing a reagent sampling shortage detection mechanism according to the present invention.

FIG. 2 is a perspective view of the whole blood cell immunoassay apparatus with the side panel removed, and FIG. 3 is a view schematically showing the entire configuration of the whole blood cell immunoassay apparatus. is there. FIG. 4 is a diagram of a main part of the whole blood blood cell immunoassay apparatus viewed from above, and FIG. 5 is a view schematically showing a configuration of a main part of the whole blood cell immunoassay apparatus.

In these figures, 1 is an apparatus case,
On the front surface 2 side, a sample setting section 5 for setting a sample container 4 containing whole blood 3 as a sample is formed in a state in which it is recessed inward. Reference numeral 6 denotes a measurement key constituted by a door 7 for opening and closing the sample setting unit 5, and is configured to be turned on (switch ON) by closing the door 7. The door 7 is configured to swing back and forth with the lower end as a fulcrum in the front-rear direction. Inside the door 7, a plurality of sample containers 4 of different sizes can be selected and set on the upper surface. The sample container holder 8 having the above-mentioned hole is provided so as to be rotatable around the vertical axis and swingable in the front-rear direction integrally with the door 7.

Below the side surface 9 of the apparatus case 1, an immunity measuring unit 10 for performing an immunological measurement and a blood cell counting / measuring unit 11 for performing a blood cell measurement are viewed from the front side in order from the side closer to the front surface 2. An electromagnetic valve portion 12 that is arranged in a straight line and includes a plurality of electromagnetic valves 12a is provided. Above the side surface 9, the immunoassay unit 1 arranged in a straight line between the sample setting unit 5 and the blood cell count measurement unit 11 is arranged.
Probe unit 13 as a sampling mechanism that moves linearly along zero and blood cell count measurement unit 11
Is provided.

In FIG. 3, reference numeral 14 denotes a dispenser, 15 denotes a diluting liquid container, 16 denotes a hemolytic reagent container, and 17 denotes a liquid discharging pump. These 15 to 17 are all connected to the electromagnetic valve section 12. I have. Reference numeral 18 denotes a waste liquid container connected to the pump 17.

In the present embodiment, the immunoassay section 10 is configured to measure CRP (C-reactive protein which is an acute phase protein) by a latex immunoturbidimetry. That is, in FIGS. 3 and 5, reference numeral 19 denotes a reagent receiving cell having an open top surface, and a light irradiating portion 20 a formed of a light emitting diode on both sides is provided at the bottom of the sample receiving cell 19.
And a photodetector 20b comprising a photodiode
A flow photometric cell 20 for RP measurement is connected via a flow path 21. A liquid transfer infusion device 23 is connected to the flow path 22 on the outlet side of the flow photometric cell 20 via the three-way solenoid valve 12b. The downstream side of the three-way solenoid valve 12b is connected to the pump 17 via the solenoid valve part 12. Reference numerals 24, 25, and 26 denote reagent containers containing reagents used for CRP measurement, respectively.
Reagent), a buffer (hereinafter, referred to as R2 reagent), and an anti-human CRP-sensitized latex immunoreagent (hereinafter, referred to as R3 reagent).

The reagent receiving cell 19 and the reagent container 24
Are arranged in a straight line with respect to the setting position of the sample container 4 in the sample setting section 5, and these 19 to 26 are arranged in a straight line.
Is a lid 28 that swings up and down by a solenoid 27.
It is configured to be opened and closed in a lump. Reference numeral 29 denotes an electronic cooler 30 made of, for example, a Peltier device.
In the example shown, reagents R2 and R
3 are accommodated therein.

The infusion device 23 not only controls the flow of the reaction solution (reagent for immunoassay and the whole blood sample) in the sample receiving cell 19 to the flow photometric cell 20 at the time of CRP measurement. The sample receiving cell 19, the flow metering cell 20, and the like constitute a reaction solution stirring mechanism as described below. That is, as shown in FIG. 1, in a state where the reaction solution is contained in the sample receiving cell 19, the infusion device 23 slides several times before the CRP measurement, so that the inside of the sample receiving cell 19 is moved. The reaction solution of (1) is transferred to the sample receiving cell 19 and the flow photometric cell
It is configured to reciprocate back and forth over 0.

More specifically, the dispenser 23 is configured such that its sliding stroke is controlled.
A sample receiving cell 19, R1 reagent, R2 reagent, and the specimen at the time when the (whole blood) 3 is accommodated, by a stroke a set corresponding to their total L _1, syringe pump 23 several times (For example, three times), the three-way solenoid valve 12b slides in a state where the flow metering cell 20 communicates with the infusion set 23 to reciprocate the reaction solution back and forth, and the first reaction solution of the carried out stirring at the time of the reaction liquid R3 reagent was added, syringe pump 23 several times until the stroke b end which is set to correspond to the total amount of them L ₂ (for example, 3 times),
It is configured to perform the second stirring by sliding.

During the CRP measurement, the infusion set 23 slides only once to the end of the stroke b so that the reaction solution flows through the flow photometering cell 20. The stroke of the dispenser 23 and the length of the flow paths 21 and 22 are such that when the dispenser 23 slides to the stroke b end, the foremost end P of the reaction solution in the flow paths 21 and 22 is a three-way solenoid valve. 12b is located upstream (between the three-way solenoid valve 12b and the flow metering cell 20), and the tail Q is located upstream of the flow metering cell 20 (in the illustrated example, within the channel 21 and the sample receiving cell 19). Near the exit). In this state, the three-way solenoid valve 12b switches the flow path, shuts off the infusion device 23, and sets the flow path before and after the three-way electromagnetic valve 12b (the flow path on the flow photometric cell 20 side and the pump 17 side). When the pump 17 is connected, the pump 17 sucks the reaction liquid in the flow path and discharges it to the waste liquid container 18.

According to this reaction solution stirring mechanism, when the reaction solution reciprocates back and forth between the sample receiving cell 19 and the flow photometric cell 20, the connection between the sample receiving cell 19 and the flow path 21, the inlet of the flow photometric cell 20 At the outlet and the outlet, respectively, the cross section of the flow path changes, so that turbulent flow occurs in the reaction liquid at these portions where the cross section of the flow path changes, as shown in FIG.
Since there are many sites where turbulence occurs, stirring is performed efficiently.

Next, in this embodiment, the blood cell counting / measuring unit 11 uses the electric resistance method to measure WBC (white blood cell count), RBC (red blood cell count), PLT (platelet count), MC
It is configured to measure V (red blood cell volume), Hct (hematcrit value), and Hgb (hemoglobin concentration) by an absorption spectrophotometric method in the cyanmethemoglobin method. That is, in FIG.
Is a WBC / Hgb blood cell count measurement cell (hereinafter simply referred to as WBC
Measurement electrode 31 for measuring WBC
a, 31b and light irradiator 31 for measuring Hgb
c, a light receiving section 31d. 32 is RBC / PLT
With a blood cell count measurement cell (hereinafter simply referred to as RBC cell),
Measuring electrodes 32a for measuring RBC and PLT,
32b. These cells 31 and 32 are shown in FIG.
As shown in the figure, the reagent receiving cell 1 in the immunoassay section 10
9 and reagent containers 24-26. The WBC cell 31 also serves as a waste liquid chamber for cleaning a sampling nozzle 40 described later.

Further, the probe unit 13 is constituted, for example, as follows. That is, in FIG. 2 and FIG. 4, reference numeral 33 denotes a nozzle unit, which is appropriately connected to a timing belt 35 provided in a horizontal direction along a base member 34 which is provided upright. It is configured to be fixed by a member 36 so that it can reciprocate horizontally.

More specifically, the nozzle unit 33 is provided between the sample setting section 5 and the blood cell counting / measuring section 11 for performing blood cell measurement. It is configured to reciprocate almost directly above the reagent containers 24-26 of the part 10, the reagent receiving cell 19, the WBC cell 31, and the RBC cell 32. 37 is a motor for driving the timing belt 35, 38 is a pair of guide members for guiding a guided member 39 provided in the nozzle unit 33, and these are attached to the base member 34 via appropriate members. .

Reference numeral 40 denotes a sampling nozzle, which is attached to a nozzle holder 42 that moves vertically in the nozzle unit 33 by a timing belt 41. The distal end side (lower end side) of the sampling nozzle 40 is configured to pass through a sampling nozzle cleaning device 43 provided in the nozzle unit 33 to clean the outer periphery of the distal end portion. 44 is a motor for driving the timing belt 41. A sensor 45 detects whether or not the sampling nozzle 40 is at the home position (fixed position).

In FIG. 3, reference numeral 46 denotes a microcomputer as a control / arithmetic device which comprehensively controls each part of the device and performs various arithmetic operations using outputs from the immunological measurement part 10 and the blood cell count measurement part 11. (MP
U) and 47 are drivers for transmitting drive signals to the electromagnetic valve section 12 and the motors 37 and 44 of the probe unit section 13 based on commands from the MPU 46, and 48 are output signals from the immunological measurement section 10 and the blood cell count measurement section 11. To process the MPU
A signal processing unit to be sent to 46, 49 is a device for displaying a result obtained by processing in the MPU 46 and the like, for example, a color display, and 50 is a printer as an output device.

In FIG. 3, the dotted lines show the flow of the specimen 3 and various reagents, the slightly thick dashed line shows the control signal, and the thin dashed line shows the flow of the signal obtained by the measurement. .

In this embodiment, in the whole blood cell immunoassay described above, the reagent sampling shortage detecting mechanism is
It is configured as follows. That is, in a state where the reaction solution of a predetermined amount in the sample receiving cell 19 is accommodated (state reaction in Figure 1 to a level indicated by L ₂ is accommodated), syringe pump 23 to the stroke b end When the reaction solution in the sample receiving cell 19 is moved forward by sliding, the tail Q of the reaction solution in the flow path 21 becomes the flow photometric cell 2.
In the state where the reaction solution in the sample receiving cell 19 is set to be lower than the set value,
The tail Q of the reaction solution reaches the flow photometric cell 20, and the light irradiation unit 20a and the light detection unit 20b of the flow photometric cell 20
By detecting the tail P of the reaction solution, the shortage of reagent sampling is detected.

That is, in order to perform CRP measurement, when the infusion set 23 slides to the end of the stroke b and the reaction solution flows through the flow photometric cell 20, the total of the reagents R1, R2, R3 and the specimen 3 If the amount is equal to or greater than the set value, the last
Are located on the upstream side of the flow photometric cell 20, the light beam emitted from the light
After passing through the reaction solution inside the detector and entering the photodetector 20b, the end Q of the reaction solution is not detected, but the reagents R1, R2, R3 and the sample 3 are not detected without noticing that the reagent is insufficient. When the sample is sampled, the amount of the reaction solution contained in the sample receiving cell 19 (total amount of the reagents R1, R2, R3 and the sample 3) decreases. When the dispenser 23 slides to the end of the stroke b to move the reaction solution in the sample receiving cell 19 forward, the tail Q of the reaction solution reaches the inside of the flow photometric cell 20. .

Therefore, air bubbles enter the light beam irradiated on the flow photometric cell 20 and the light detection unit 20b detects air and emits an abnormal signal. Has been detected, and as a result,
Insufficient sampling of the reagent will be detected. Then, the detection result is displayed as an error on the display device 49.

This operation is, as shown by a virtual line in FIG.
A liquid level detection sensor utilizing conductivity or an optical liquid level detection sensor 51 can be provided near the bottom (outlet) of the sample receiving cell 19, but in this case, a dedicated liquid level detection sensor is used. In addition, it is practically extremely difficult to secure a space for installing the liquid level detection sensor near the bottom of the sample receiving cell 19. In this regard, in the present invention, the light irradiation unit 20a of the flow photometric cell 20 for immunoassay is used.
In addition, since the light detection unit 20b is also used as a sensor for detecting the tail Q of the reaction solution, a dedicated liquid level detection sensor and its installation space are not required, the number of members is reduced, and the device configuration is reduced. Can be made compact and simple.

The operation of the whole blood cell immunoassay apparatus having the above configuration will be described with reference to FIGS. 6 to 8, which show an example of a measurement procedure.

First, the measurement key 6 is turned on (step S
1), the sampling nozzle 40 at the fixed position is R2
It moves to the position of the reagent (Step S2), and aspirates the R2 reagent (Step S3). After the suction of the reagent, the sampling nozzle 40 moves upward, and its outer surface is washed with a diluting liquid as a washing liquid supplied to the sampling nozzle washer 43. Then, the sampling nozzle 40
Returns to the position of the R2 reagent.

Next, the sampling nozzle 40 is connected to R1
It moves to the position of the reagent (Step S4), and aspirates the R1 reagent (Step S5). After the suction of the reagent, the sampling nozzle 40 moves upward, and its outer surface is washed with a diluting liquid as a washing liquid supplied to the sampling nozzle washer 43. Then, the sampling nozzle 40
Returns to the position of the R1 reagent.

Then, the sampling nozzle 40 moves to the sample setting position (Step S6), and aspirates the sample (whole blood) 3 in the sample container 4 for CRP measurement (Step S7). After this sample aspiration, the sampling nozzle 40
Moves upward, and its outer surface is cleaned by a diluting liquid as a cleaning liquid supplied to the sampling nozzle cleaning device 43. Thereafter, the sampling nozzle 40 returns to the position of the sample 3.

Then, the sampling nozzle 40 moves to the position of the sample receiving cell 19 (step S8), and the sample 3,
The R1 reagent and the R2 reagent are discharged into the sample receiving cell 19 (Step S9).

Thereafter, the dispenser 23 slides several times by the stroke a to perform the first stirring of the reaction solution (step S10).

The sampling nozzle 4 after the ejection is completed
0 moves to the position of the WBC cell 31 (step S1).
1) The sample 3, R1 reagent, and R2 reagent remaining inside are mixed with the diluent supplied by the pump 17 in WBC.
The liquid is discharged into the cell 31. And the sampling nozzle 4
In the case of 0, the outer surface is cleaned by the diluting liquid as the cleaning liquid supplied to the sampling nozzle cleaning device 43. The waste liquid in this washing is received by the WBC cell 31,
The liquid is discharged to a waste liquid container 18 by a pump 17. The diluent is again supplied from the sampling nozzle washer 43 to the WBC cell 3
1 and discharged to the waste liquid container 18 by the pump 17 to wash the WBC cell 31. The receiving of the waste liquid may be performed by the RBC cell 32.

The sampling nozzle 4 after the cleaning is completed
0 moves to the sample setting position (Step S12), and aspirates the sample 3 in the sample container 4 for CBC measurement (Step S13). After this sample aspiration, the sampling nozzle 40 moves upward and the sampling nozzle washer 4
The outer surface is cleaned by the diluting liquid as the cleaning liquid supplied to 3.

The sampling nozzle 4 after the cleaning is completed
0 indicates that the specimen 3 is discharged into the WBC cell 31, while a predetermined amount of the diluent in the diluent container 15 is injected into the WBC cell 31 via the electromagnetic valve unit 12, and the primary dilution of the CBC specimen is performed ( Step S14).

The sampling nozzle 40 located at the position of the WBC cell 31 aspirates the primary diluted CBC sample by a predetermined amount and moves to the RBC cell 32 (step S15).
The aspirated primary diluted CBC sample is transferred to this cell 32
(Step S16) and diluent container 1
A predetermined amount of the diluting liquid in 3 is injected into the RBC cell 32 through the electromagnetic valve section 10, and the secondary dilution of the CBC sample is performed (Step S17).

After the primary dilution and the secondary dilution have been completed, the hemolytic agent in the hemolytic agent container 16 is supplied to the WBC via the electromagnetic valve 12.
A predetermined amount is injected into the cell 31 and the measurement of WBC and Hgb is performed, while the measurement of RBC and PLT is performed in the RBC cell 32 (step S18), and the data at that time is taken into the MPU 46 via the signal processing unit 48. It is.

When the measurement is completed, the WBC cell 31 and R
The BC cell 32 is washed with a diluent (step S1).
9).

As described above, steps S11 to S11
In 19, the CBC measurement is performed in the blood cell counting / measuring unit 11, and during this period (about 60 seconds), the hemolysis reaction proceeds between the specimen 3, the R1 reagent, and the R2 reagent in the reagent receiving cell 19. At the same time, interfering substances are removed.

When the CBC measurement is completed, the sampling nozzle 40 at the position of the RBC cell 32
The WBC cell 31 is moved to the position of the cell 31 and the inner surface of the WBC cell 31 is washed away with the diluent supplied by the pump 17, and the outer surface is washed with the diluent supplied as the cleaning liquid to the sampling nozzle washer 43. The waste liquid at this time is received by the WBC cell 31 and discharged to the waste liquid container 18 by the pump 17. Then, the dilution liquid is supplied to the WBC cell 31 again from the sampling nozzle cleaning device 39 and discharged to the waste liquid container 18 by the pump 17 to clean the WBC cell 31. Thereafter, the sampling nozzle 40 moves to the position of the R3 reagent (Step S2).
0), aspirate R3 reagent (step S21). After the suction of the reagent, the sampling nozzle 36 is connected to the reagent receiving cell 1.
Nine positions are moved (step S22), and the R3 reagent is discharged into the reagent receiving cell 19 (step S23), and the R3 reagent is mixed into the reaction solution of the sample 3, the R1 reagent, and the R2 reagent.

After the discharge of the R3 reagent, the sampling nozzle 40 moves to the position of the WBC cell 31, and the pump 17
The inside surface of the WBC cell 31 is washed away with the diluting solution supplied by the above-described process, and the outer surface thereof is washed with the diluting solution as the cleaning solution supplied to the sampling nozzle washer 43. The waste liquid at this time is received by the WBC cell 31 and discharged to the waste liquid container 18 by the pump 17. Then, the diluting liquid is supplied to the WBC cell 31 again from the sampling nozzle cleaning device 43 and discharged to the waste liquid container 18 by the pump 17 to clean the WBC cell 31.

Then, the dispenser 23 is slid several times by the stroke b to perform the second stirring of the reaction solution (step S24). When the immune reaction occurs, the dispenser 23 is dispensed.
However, by sliding again to the end of the stroke b, the reaction liquid is circulated to the flow photometric cell 20 and the CRP measurement is performed (step S25). It is captured. When the measurement is completed, the reagent receiving cell 19 is washed with the diluent (step S26), and all the measurements are completed (step S2).
7).

In the MPU 46, based on the data obtained by the CBC measurement performed in the blood cell counting / measuring section 11, RBC (red blood cell count), red blood cell volume (MC
V), and the like. Further, in the MPU 46, based on data obtained by the CRP measurement performed in the immunoassay section 10, a change in absorbance per predetermined time is obtained from a calibration curve obtained in advance from serum (or plasma) of a known concentration. The CRP concentration in whole blood is obtained.

In this case, for CRP measurement, CBC
Similarly to the measurement, since the whole blood to which the anticoagulant is added is used as the specimen 3, it is necessary to correct a plasma component volume error caused by using this whole blood. Therefore, RBC (red blood cell count) and red blood cell volume (M
CV), the hematocrit value (Hct) is determined, and using this hematocrit value, the CRP concentration in whole blood obtained by CRP measurement is corrected by the following correction formula to determine the CRP concentration in plasma.

That is, the CRP concentration in whole blood is defined as A,
When the hematocrit value is B, the CRP concentration in plasma C
Is determined by the following equation: C = A × 100 / (100−B)

The measured values obtained by the MPU 46 are stored, for example, in a memory built in the MPU 46, displayed on the display device 49 by item, or output by the printer 50.

As described above, in the whole blood blood cell immunoassay apparatus of the present invention, the CBC measurement is performed in the blood cell count measurement section 11 while the hemolysis and the interfering substance removal reaction are caused in the immunoassay section 10. Thus, the total time of the CRP measurement and the CBC measurement can be shortened, and the result obtained by the above-described CRP measurement can be smoothly corrected based on the result obtained by the CBC measurement.

FIG. 9 shows another embodiment of the present invention. In a state where a predetermined amount of the reaction solution is stored in the sample receiving cell 19, the infusion device 23 slides to the stroke b end. It is characterized in that, when the reaction solution in the sample receiving cell 19 is moved forward, the tail Q of the reaction solution in the flow path 21 is set near the inlet of the flow photometric cell 20.

According to this configuration, even if the liquid amount is slightly reduced, when the dispenser 23 slides to the stroke b end,
The tail Q of the reaction solution reaches the inside of the flow photometric cell 20, and the detection accuracy is improved. Other configurations and operations are the same as those of the reagent sampling shortage detection mechanism shown in FIG.

In the embodiment shown in FIGS. 1 and 9,
In any case, detection of reagent sampling insufficiency is detected at the time of CRP measurement, and if reagent sampling is insufficient, an error is displayed. However, reagent sampling insufficiency is detected when the reaction solution is stirred prior to CRP measurement. May be detected, and if the reagent sampling is insufficient, it may be configured to display that the reagent is insufficient and to prevent the subsequent measurement sequence from automatically proceeding.

[0058]

According to the present invention, by detecting that the total amount (the amount of the reaction solution) of the immunoassay reagent and the whole blood sample accommodated in the sample receiving cell has become equal to or less than the set value. In addition, erroneous measurement can be prevented when the amount of reagent is insufficient, and the light irradiating unit and light detecting unit of the flow photometric cell for immunoassay are set at the liquid level for detecting the last of the reaction solution. Since it is also used as a detection sensor, a dedicated liquid level detection sensor and its installation space are not required, the number of members can be reduced, and the apparatus configuration can be made compact and simple.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram of a reagent sampling insufficient detection mechanism according to the present invention.

FIG. 2 is a perspective view showing an example of a whole blood blood cell immunoassay apparatus with a side panel removed.

FIG. 3 is a view schematically showing an entire configuration of the whole blood cell immunoassay apparatus.

FIG. 4 is a view of a main part of the whole blood blood cell immunoassay apparatus as viewed from above.

FIG. 5 is a diagram schematically showing a configuration of a main part of the whole blood blood cell immunoassay apparatus.

FIG. 6 is a flowchart showing an example of a measurement procedure together with FIGS. 7 and 8;

FIG. 7 is a flowchart following the part shown in FIG. 6;

FIG. 8 is a flowchart following the part shown in FIG. 7;

FIG. 9 is an explanatory diagram of a reagent sampling shortage detecting mechanism showing another embodiment of the present invention.

[Explanation of symbols]

Reference numeral 10: immunoassay section, 11: blood cell count measurement section, 19: sample receiving cell, 20: flow photometry cell, 20a: light irradiation section,
20b: photodetector, 23: infusion device, Q: last.

 ──────────────────────────────────────────────────続 き Continued on the front page (72) Inventor Naruhiro Oku 2 Higashi-cho, Kichijoin-gu, Minami-ku, Kyoto, Kyoto Inside Horiba, Ltd.

Claims (2)

[Claims] 1. An immunoassay section for performing an immunoassay and a blood cell count and measurement section for performing a blood cell count measurement. The same whole blood sample is used in both of these measurement sections, and the result of the immunoassay is obtained by the blood cell count measurement. In a whole blood blood cell immunoassay apparatus configured to correct using the hematocrit value, a flow photometric cell for immunoassay is provided via a flow path at the bottom of a sample receiving cell containing a reagent for immunoassay and a whole blood sample. Connected to the flow path on the outlet side of the flow photometric cell via a three-way solenoid valve, and in a state where a predetermined amount of the reaction solution is contained in the sample receiving cell, When the injector slides to the end of the stroke to move the reaction solution in the sample receiving cell forward, the tail of the reaction solution in the flow path is set to be located upstream of the flow metering cell. , Reaction in sample receiving cell In a state in which the liquid has decreased below the set value, the end of the reaction solution reaches the flow photometer cell, and the light irradiation unit and the light detection unit of the flow photometer cell detect the end of the reaction solution. And a reagent sampling insufficiency detecting mechanism in the whole blood blood cell immunoassay, wherein the reagent sampling insufficiency is detected. 2. In a state in which a predetermined amount of a reaction solution is stored in a sample receiving cell, when the infusion device slides to the stroke end to move the reaction solution in the sample receiving cell forward, 2. The method according to claim 1, wherein the tail of the reaction solution in the flow path is set near the entrance of the flow photometering cell.
4. A mechanism for detecting insufficient sampling of a reagent in the whole blood blood cell immunoassay according to 4.