JP2002055069A - Blood measuring device and whole blood immunoassay device as well as sampling probe used for devices - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a measuring device, in which a hematocrit value can be measured on a specimen in a small amount and simultaneously with the sampling of the specimen, on the basis of the electric conductivity of the specimen, and to provide a sampling probe which is suitably used for the device. SOLUTION: The blood measuring device is constituted, in such a way that an electrode 33 and an electrode 34 which are immersed in the specimen 2 to be set to continuity are provided at the tip of the sampling probe 28, and that the electrical conductivity across the electrodes 33, 34 in the sampling of the specimen 2 is measured.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood measuring device including a whole blood immunological measuring device, and a sampling probe used for the blood measuring device.

[0002]

2. Description of the Related Art Among various blood measuring devices, for example, a whole blood immunological measuring device measures a hematocrit value which is a useful reference in diagnosing anemia and other disease states.

[0003] The hematocrit value is a volume ratio of the whole blood sample (which is a specimen, and is appropriately referred to as whole blood) in which the blood cells therein are compressed to a predetermined volume (that is, the volume of the compressed blood cells / the whole blood sample). ).

Since the hematocrit value represents the blood cell volume / the whole blood sample, it serves as an index for converting the concentration of the whole sample into the concentration in components other than blood (blood concentration).
-When measuring a component that does not contain a measurement sample in blood cells, such as reactive protein), it is necessary to convert the whole blood measurement value to the blood component concentration. Need to be measured.

As a method for obtaining this hematocrit value,
Hgb by the spectrophotometric method in the cyanmethemoglobin method
As an existing technique, there is a method of obtaining a hematocrit value from electric conductivity instead of a method of obtaining a value (hemoglobin concentration) and converting the value into a hematocrit value.

As an example, in a whole blood immunoassay device,
As shown in FIG. 6, electrodes 64 and 65 that are electrically connected to a sample are provided in the middle of a tube 63 that connects a sample / reagent sampling probe 61 to a suction pump 62.
There is a method of measuring the hematocrit value of the sample 66 based on the electric conductivity between the electrodes 64 and 65 when the sample 66 is sucked between the electrodes 64 and 65.

[0007]

However, in this method, since the sample 66 needs to be introduced to the electrodes 64 and 65, a large amount of the sample 66 is required, and it takes a long time. there were.

That is, since only a very small amount of sample (whole blood) is required for the immunoassay, the probe 61
The sample 66 only needs to be sampled in a small amount, but in order to measure the hematocrit value by the above method, it is necessary to introduce the sample 66 to the electrodes 64 and 65. And he was wasting his time.

The problem of wastefully introducing a specimen is not limited to the whole blood immunoassay apparatus described above, but is also a common problem in various blood measurement apparatuses for measuring the electrical conductivity of a specimen.

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and has as its object to reduce the hematocrit value of a sample based on the electrical conductivity of the sample or a small amount of the sample. It is an object of the present invention to provide a measuring device capable of measuring at the same time and a sampling probe suitable for use in the measuring device.

[0011]

That is, the present invention relates to a blood measurement apparatus, wherein an electrode which is immersed in a sample and conducts is provided at the tip of a sampling probe, and the electrical conductivity between the electrodes during sample sampling is measured. (Claim 1).

According to the above-mentioned means, when the sampling probe is inserted into the sample container and the sample required for blood measurement is sampled, the electrode at the tip of the probe is conducted by the sample. The electrical conductivity can be measured.

[0013] The present invention also provides a whole blood immunoassay apparatus having a sampling probe movably provided between a sample container accommodating section and an immunoassay section, wherein an electrode which is immersed in the sample and conducts is provided at the tip of the sampling probe. Based on the electrical conductivity between the electrodes when sampling the sample,
A hematocrit value of the sample is measured (claim 3).

According to this means, when an amount of a sample required for the immunoassay is sampled, the electrode at the tip of the probe is conducted by the sample, and the electrical conductivity of the sample is measured. Therefore, the hematocrit value of the sample (whole blood) can be obtained by the above-described method. Therefore, according to the apparatus of claim 1, only by sampling a small amount of the sample at the tip of the probe, the electrical conductivity of the sample is simultaneously obtained with the sampling. Can be measured, and in addition, in the device according to the third aspect, the hematocrit value of the specimen can be measured based on the electric conductivity.

[0015] A sampling probe used in the device according to the first aspect of the present invention includes an insulating cylinder and an electrically conductive inner cylinder having substantially the same diameter as the cylinder. Inserting and holding, while configuring the probe body of the double cylinder structure, while inserting and holding inside the outer cylinder having an inner diameter slightly larger than the outer diameter of the probe body and having conductivity, the inner cylinder and the outer cylinder The tip portion is configured as an electrode for measuring the electrical conductivity of the sample (claim 2). In the sampling probe used in the device according to claim 3, the electrode is used for measuring the hematocrit value of the sample. It is an electrode (claim 4).

In any of the above structures, a sampling probe having an electrode at the distal end portion is constituted by using an inner cylinder for sample sampling, so that a sampling probe suitable for the above-described apparatus can be manufactured at a low cost. Provided.

At this time, the outer cylindrical body of the probe body is made to have a heat shrinking property, and if this cylindrical body is thermally shrunk (claim 5), for example, a troublesome work such as bonding is not required, A cylindrical probe body can be obtained, and
If the tip of the outer cylinder constituting the electrode is drawn and the end of the probe is pressed against the inner surface of the drawing (claim 6), the positioning of one end of the probe is achieved. Therefore, there is an advantage that the sampling probe can be configured only by fixing only the other end of the probe body to the outer cylinder.

[0018]

Embodiments of the present invention will be described with reference to the drawings. 1 to 3 show one embodiment of the present invention.

Embodiments of the present invention will be described below with reference to the drawings. 1 to 3 show a whole blood immunity measuring apparatus as an example of a blood measuring apparatus. In these figures, reference numeral 1 denotes an apparatus case, and a storage section 4 of a sample container 3 containing whole blood 2 as a sample. And an immunoassay unit 5, and a probe unit 6 that moves linearly across the sample container housing unit 4 and the immunoassay unit 5.

Reference numeral 7 denotes a measurement key provided in the sample container housing section 4, reference numeral 8 denotes a dispenser, reference numeral 9 denotes a diluent container, reference numeral 10 denotes a hemolysis reagent container, and reference numeral 11 denotes a pump. It is connected to the unit 12. Reference numeral 13 denotes a waste liquid container connected to the pump 11.

The immunoassay section 5 is configured to measure CRP. That is, in FIG.
Cell for measuring P (hereinafter referred to as CRP cell)
At the bottom, a flow photometering cell 14c for CRP measurement having a light irradiator 14a and a photodetector 14b is communicated, and is configured so that the liquid contained in the flow photometerer 14c can be appropriately stirred. I have.

Reference numerals 15 to 17 denote containers containing reagents used for CRP measurement, respectively, a hemolytic reagent (hereinafter, referred to as R1 reagent), a buffer (hereinafter, referred to as R2 reagent), and an anti-human CRP-sensitized latex immunoreagent ( Hereinafter, referred to as R3 reagent).

The CRP cell 14 and the reagent container 1
5 to 17 are arranged in a straight line with respect to the set position of the sample container 3 in the sample container housing portion 5;
Reference numeral 7 denotes a lid 1 which swings up and down by a solenoid 18.
9 so as to be opened and closed collectively.
Reference numeral 20 denotes a cooler box provided with an electronic cooler 21 composed of, for example, a Peltier element, and contains reagents R2 and R3 in the illustrated example.

In the configuration diagram of the probe unit 6,
Reference numeral 22 in the drawing denotes a probe unit, which is configured to be able to reciprocate in a horizontal direction by a timing belt 24 provided in a horizontal direction along a base member 23 which is provided upright. I have.

Reference numeral 25 denotes a motor for driving the timing belt 24, and reference numeral 26 denotes a pair of guide members for guiding a guided member 27 provided on the probe unit 22, which are attached to the base member 23 via appropriate members. Have been.

Reference numeral 28 denotes a sample / reagent sampling probe which is connected to the pump 11 via a tube 29 and is attached to a probe holder 31 which moves in a vertical direction in the probe unit 22 by a timing belt 30.

The distal end (lower end) of the sampling probe 28 is inserted through a probe cleaner 32 provided in the probe unit 22 so that the outer periphery of the distal end is cleaned.

The sampling probe 28
Is provided with electrodes 33 and 34 that are immersed in the sample 2 and conduct, and the electrodes 3 and 34 at the time of sampling the sample 2 are provided.
The apparatus is configured to measure the hematocrit value of the sample 2 based on the electric conductivity between the samples 3 and 34.

Reference numeral 35 denotes a motor for driving the timing belt 30. Reference numeral 36 denotes a sensor for detecting whether the sampling probe 28 is at the home position (fixed position).

Numeral 37 denotes a microcomputer (MCU) as a control / arithmetic unit which comprehensively controls each part of the apparatus and performs various arithmetic operations using the output from the CRP measuring part 5, and numeral 38 designates a command from the MCU 37. Motors 25 and 35 of the solenoid valve section 12 and the probe unit section 6 based on
A driver for sending a drive signal to the CRP measuring unit 39;
A signal processing unit for processing an output signal from the microcomputer 37 and sending the processed signal to the MCU 37, a device 40 for displaying a result obtained by processing in the MCU 37, for example, a color display, and a printer 41 as an output device.

The operation of the whole blood immunoassay apparatus will be briefly described. First, when the measurement key 7 is turned on, the sampling probe 28 at a fixed position moves to the position of the R2 reagent and aspirates the R2 reagent. After that, the outer surface of the sampling probe 28 is washed and moved to the position of the R1 reagent,
Aspirate R1 reagent. After this, sampling probe 2
8, the outer surface of the sample probe 28 is moved to the sample container housing section 4, the sample (whole blood) 2 in the sample container 3 is aspirated for CRP measurement, and thereafter, the outer surface of the sampling probe 28 is washed. After moving to the CRP cell 14 position, the sample 2, the R1 reagent, and the R2 reagent are discharged into the CRP cell 14, and the sample 2,
The hemolysis reaction proceeds between the R1 reagent and the R2 reagent to remove interfering substances.

Next, the sampling probe 28 aspirates the R3 reagent, discharges the R3 reagent into the CRP cell 14, and the R3 reagent is mixed into the reaction solution of the sample 2, the R1 reagent, and the R2 reagent, and And an immune response is generated
The P measurement is performed, and the data at that time is taken into the MCU 37 via the signal processing unit 39.

In the MCU 37, the CR in the CRP measuring unit 5
Based on the data obtained by the P measurement, the absorbance change per predetermined time is determined in advance by using a known concentration of serum (or plasma).
The CRP concentration in the whole blood can be obtained from the calibration curve determined in advance.

In this case, for the CRP measurement, the sample 2
Therefore, it is necessary to correct the plasma component volume error caused by using this whole blood.

In this correction, when the sample 2 is sampled by the sampling probe 28, the sampling probe 28 is immersed in the sample 2 and the sample ( The hematocrit value (Hct) of (whole blood) 2 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 MCU 37 are stored in, for example, a memory built in the MCU 37, displayed on the display device 40 by item, or printed by the printer 41.

Next, the structure of the sampling probe 28 will be described. As shown in FIG. 3, the sampling probe 28 has a short, small-diameter cylindrical body (for example, made of ceramic) 42 having an insulating property, and a long, electrically conductive, substantially same diameter as the cylindrical body 42. The inner tube 43 (for example, made of stainless steel) is inserted into a heat-shrinkable tube body 44 made of, for example, Teflon (trade name of DuPont) having an insulating property in a state where the inner tube 43 is protruded. The tubular body 44 is thermally contracted, and the protruding surface of the inner barrel 43 and the end of the tubular body 44 are connected, for example, by Araldite (trade name of Nagase & Co., Ltd.)
The probe body 45 having a double cylindrical structure is formed by bonding with an adhesive such as.

On the other hand, an outer cylinder 46 made of, for example, stainless steel having an inner diameter slightly larger than the outer diameter of the probe body 45 is prepared.
The distal end portion 46a of the outer tube 46 is drawn to the inner diameter of the probe body 45, and the end of the tube body 44 is protruded while the end of the probe body 45 is pressed against the inner surface of this drawing process. In this state, the probe body 45 is inserted into the inside of the outer cylinder 46, and the end of the outer cylinder 46 and the protruding surface of the cylinder 44 are adhered to each other with an adhesive such as Araldite. And the tip portion 46a of the outer cylinder 46 constitute electrodes 33 and 34, respectively, to constitute the sampling probe 28.

In the drawing, 57 is a connecting member for connecting the fork-shaped member 31a of the probe holder 31, 58 and 59 are extraction port members for the electrodes 33 and 34, the connecting member 57 is connected to the outer cylinder 46, and The port members 58 and 59 are fixed to the inner cylinder 43 and the outer cylinder 46 by, for example, silver brazing.

According to the sampling probe 28 having the above-described configuration, when the sampling probe 28 is inserted into the sample container 3 and the sample 2 in a necessary amount for the immunoassay is sampled, the electrodes 33 and 34 at the tip of the probe are electrically connected by the sample 2. Then, the electric conductivity of the specimen 2 is measured.

The hematocrit value of the specimen (whole blood) 2 is obtained based on the electric conductivity between the electrodes 33 and 34 at this time. Therefore, in the sampling probe 28 having the above structure, the hematocrit value is Just by sampling a small amount of the sample 2, the electrical conductivity of the sample 2 and the hematocrit value based on the electrical conductivity can be measured simultaneously with the sampling of the sample 2.

In the above embodiment, the present invention has been described with reference to a whole blood immunoassay apparatus. However, the sampling probe 28 having the above structure is used in various blood measurement apparatuses, and the electrical conduction of the specimen 2 is measured. The degree may be measured.

A sampling probe 28 having electrodes 33 and 34 according to another embodiment is shown in FIGS. 4 (A) to 4 (C).
5 (A) to 5 (D). The sampling probe 28 shown in FIG. 4A has a structure obtained by cutting off the aperture portion 46a at the tip of the sampling probe 28 shown in FIG. 4, and is similar to the sampling probe 28 shown in FIG. Sampling probe 28 shown in FIG.
In the above, the insulating cylinder 42 provided in these
This has a function of eliminating a step between the sample 3 and the cylinder 44 to prevent the sample 2 from remaining.

The sampling probe 2 shown in FIG.
8 is a state in which the tip of the conductive inner cylinder 43 is slightly protruded, the inner cylinder 43 is inserted into the insulating cylinder 44, and the tip of the cylinder 44 is slightly protruded. This cylindrical body 44 is inserted into a conductive outer cylindrical body 46, and the outer cylindrical body 46 is covered with an insulating protective cylindrical body 47 in a state where the tip of the outer cylindrical body 46 is slightly protruded. (A),
In (B), the electrodes 33 and 34 are constituted by the tip portions of the inner cylinder 43 and the outer cylinder 46.

The sampling probe 2 shown in FIG.
Reference numeral 8 denotes a metal material 51, 5 constituting the electrodes 33, 34 on an outer surface of a cylindrical body 50 made of, for example, ceramic having insulating properties.
2 is fixed at a phase of, for example, 180 degrees (means such as vapor deposition or adhesion is selected).

The sampling probe 2 shown in FIG.
Reference numeral 8 denotes a case in which a cylindrical body 53 constituting the electrode 33 is provided inside the distal end side of the insulating cylindrical body 44, and the cylindrical body 54 constituting the electrode 34 is separated from the cylindrical body 53.
5B. The sampling probe 28 shown in FIG. 5B is the sampling probe 2 shown in FIG.
8, the cylinder 54 constituting the electrode 34 is provided on the inner surface of the cylinder 44.

The sampling probe 2 shown in FIG.
Reference numeral 8 denotes a state in which a metal material 55 constituting the electrode 33 is fixed to the outside of the distal end side of the insulating tubular body 44 (means such as vapor deposition or adhesion is selected), and the electrode material is separated from the metal material 55. 34 is provided on the outer surface of the cylindrical body 44, and the sampling probe 2 shown in FIG.
Reference numeral 8 denotes a sampling probe 28 shown in FIG. 5C, in which a cylinder 56 constituting the electrode 34 is provided on the inner surface of the cylinder 44.

[0048]

As described above, according to the present invention, a measuring apparatus capable of measuring a hematocrit value based on the electric conductivity of a sample or a small amount of a sample at the same time as sampling the sample based on the electric conductivity. And a sampling probe suitable for use in this device.

[Brief description of the drawings]

FIG. 1 is a perspective view of a whole blood immunoassay apparatus seen through an apparatus case.

FIG. 2 is a block diagram of a whole blood immunoassay apparatus.

FIG. 3 is a cross-sectional view of a sampling probe in which a main part is taken out and enlarged.

FIGS. 4A to 4C are configuration diagrams of a tip portion of a sampling probe according to another embodiment.

FIGS. 5A to 5D are configuration diagrams of a tip portion of a sampling probe according to still another embodiment.

FIG. 6 is a configuration diagram of a conventional electrode arrangement.

[Explanation of symbols]

4 ... sample container housing part, 5 ... immunoassay part, 28 ... sampling probe, 33,34 ... electrode.

 ──────────────────────────────────────────────────続 き Continuing on the front page F term (reference) 2G045 AA06 AA13 CA25 DA36 DA77 FA11 FA34 FA40 FB03 GC10 JA07 2G058 AA09 BA01 BB02 BB07 BB12 EA02 EA04 ED02 ED11 ED12 ED15 FA01 FB07 GA06 GA11 GD02 GD03 AGC08 FB02 HC07 HC13 HC19 HC21

Claims (6)

[Claims] 1. A blood measurement apparatus comprising an electrode immersed in a sample and conducting, provided at the tip of a sampling probe, and configured to measure the electrical conductivity between the electrodes when the sample is sampled. 2. A sampling probe for use in a blood measurement apparatus according to claim 1, wherein the insulating cylinder and the conductive inner cylinder having substantially the same diameter as the cylindrical body are electrically insulated. While holding the inside of the cylindrical body having a, to constitute a probe body of a double cylindrical structure, while the inner diameter is inserted and held inside the outer cylinder having a conductivity of a slightly larger diameter than the outer diameter of the probe body,
A sampling probe wherein the distal ends of the inner cylinder and the outer cylinder are configured as electrodes for measuring the electrical conductivity of a sample. 3. In a whole blood immunoassay apparatus provided with a sampling probe movably across a sample container housing section and an immunoassay section, an electrode which is immersed in the sample and conducts is provided at the tip of the sampling probe, and the sample is sampled. A whole blood immunoassay device configured to measure a hematocrit value of a specimen based on electrical conductivity between electrodes at the time. 4. A sampling probe for use in the whole blood immunoassay apparatus according to claim 3, wherein an insulating cylinder and a conductive inner cylinder having substantially the same diameter as the cylinder. By inserting and holding inside the cylindrical body having insulation properties, the probe body having the double cylindrical structure is formed, while being inserted and held inside the conductive outer cylinder having an inner diameter slightly larger than the outer diameter of the probe body. A tip portion of the inner cylinder and the outer cylinder is configured as an electrode for measuring a hematocrit value of the sample. 5. An outer tubular body of a probe body has a heat shrinking property, and the tubular body is inserted into an insulating tubular body and a conductive inner tubular body and then thermally contracted, 5. The sampling probe according to claim 2, wherein the sampling probe has a double cylinder structure. 6. The sampling probe according to claim 2, wherein the tip of the outer cylinder constituting the electrode is drawn, and the end of the probe body is pressed against the inner surface of the drawing.