JP4041826B2 - Blood test measuring instrument and measurement value correction method - Google Patents

Description

  The present invention relates to a blood test measuring instrument for measuring a specific component in blood and a method for correcting a measured value.

  Japanese Utility Model Publication No. 60-38216 (Patent Document 1) is known as a conventional blood test tool. As shown in FIG. 8, the liquid analysis instrument a has a reagent layer b, a liquid absorption layer c, and a covering member d that react with specific components in the liquid, and a small hole is formed in the uppermost covering member d. e is provided. And this liquid analysis instrument a is used as follows. That is, blood is applied onto the small hole e of the covering member d. The applied blood is diffused in the liquid absorbent member c through the small holes e, eventually reaches the reagent layer b, and causes a color reaction by the reagent contained in the reagent layer b. A specific component in blood is measured by measuring the coloration after the elapse of a certain time with a measuring instrument.

  In order to measure a specific component in blood using the liquid analysis instrument a as described above, sufficient blood must be supplied to the liquid absorbent member c from the small hole e as necessary. However, the blood of the sample is punctured with a scalpel or a needle or the like, and a squeezing operation is performed to collect a very small amount on the skin. Further, in the above-described liquid analysis instrument a, a small hole is simply formed in the uppermost covering member d. Since e is only provided, the position of the small hole e is confirmed by the fingertip, so blood is attached around the small hole e and the blood attached to the fingertip cannot be supplied to the small hole e well. It was. In addition, when blood on the fingertip spreads without being spherical, or when blood is collected from the abdominal wall or earlobe, it is very difficult to supply to the small hole e.

  In order to solve such a problem, Japanese Patent Laid-Open No. 3-99265 (Patent Document 2) is known. As shown in FIG. 9, this liquid analysis instrument A has an instrument main body d having a liquid absorbent member a and a reagent layer c on one side, a liquid absorption opening at one end, and the other end absorbing the liquid. A thin tube O is provided so as to be in contact with the sex member i. While this invention has solved the above problems, it has created new problems. When blood is absorbed by capillary action from a fingertip or the like by capillary action, if the capillary tip is pressed against the skin surface and the capillary tube is blocked, blood supply from the skin stops before the necessary amount of blood is absorbed. Measurement could not be started or accurate measurement could not be performed. Also, when removing a blood test instrument from the measuring instrument, especially when measuring the blood of a third person in a ward or the like, there is a risk that the measurer touches the blood of the third person and may infect hepatitis B, AIDS, etc. .

Japanese Utility Model Publication No. 60-38216

Japanese Patent Laid-Open No. 3-99265

  The object of the present invention is to allow blood to be collected easily and to obtain an accurate measurement value regardless of the blood form, collection site, and collection technique as described above, and to ensure safety when discarding the blood test device. It is to provide a blood test tool and a blood test measuring device in consideration.

The above object is achieved by the following inventions (1) to (6).
(1) A method for obtaining a correction value of a measured value of a blood component measured using a blood test tool equipped with a blood absorbing member carrying a reagent that reacts with a component in blood and having a known hematocrit value A method for obtaining a correction value of a measurement value of a blood component for each hematocrit value based on a coloration speed obtained by measuring a difference in the measurement value during the measurement time using the blood sample.
(2) The correction value of the measurement value of the blood component as described in (1) above, wherein the coloration speed is a difference in measurement value between any two points between 0 seconds and 6 seconds from the start of coloration. Method.
(3) A method for correcting a measured value of a blood component measured using a blood test tool provided with a blood absorbing member carrying a reagent that reacts with a component in blood, the measured value being measured during the measurement time The blood component obtained by correcting the measurement value at the measurement time with a correction value determined in advance using a blood sample with a known hematocrit value according to the coloration speed obtained by measuring the difference between Measurement value correction method.
(4) The blood component measurement value correction method according to (3), wherein the coloration speed is a difference in measurement values between any two points between 0 seconds and 6 seconds from the start of coloration.
(5) In a blood test measuring instrument used by setting and using a blood test instrument provided with a blood absorbent member carrying a reagent that reacts with a component in blood, the difference in measured value is measured during the measurement time of the blood component. A blood test measuring instrument characterized by correcting a measured value at a measuring time with a correction value determined in advance using a blood sample whose hematocrit value is known in accordance with the coloration speed obtained by the measurement.
(6) The blood test measuring device according to (5), wherein the coloration speed is a difference in measured values between any two points between 0 seconds and 6 seconds from the start of coloration.

  According to the blood test measuring instrument and the measurement value correcting method of the present invention, blood can be easily collected regardless of the blood form, the collection site, and the collection technique, and an accurate measurement value can be obtained, and the blood test tool can be discarded. Time safety is obtained.

  Hereinafter, the blood test tool and blood test measuring instrument of the present invention will be described in detail with reference to the accompanying drawings. 1 is a longitudinal sectional view showing an embodiment of a blood test device of the present invention, FIGS. 2 and 3 are perspective views of both ends of the narrow tube shown in FIG. 1, FIGS. 4 and 5 are top views of both ends of the narrow tube, and FIG. Is a longitudinal view showing the usage state of the blood test tool, and FIG. 7 is a longitudinal sectional view showing the combined usage state of the blood test tool and the blood test measuring instrument. A blood test instrument 100 of the present invention shown in FIG. 1 is mainly composed of a blood absorbent member 1 carrying a reagent that reacts with components in blood and a holder 2 having a thin tube 20 for blood inhalation. . Hereinafter, each component will be described. The blood absorbent member 1 is obtained by impregnating a reagent with a porous membrane as a carrier. The porous membrane desirably has a pore size that can filter out red blood cells in blood. By using a porous membrane, especially in a reagent system that includes a process of reacting with oxygen in the atmosphere as a substrate, such as an oxidase reaction, even after the sample is spread on the reagent layer, the sample receiving side is covered with the sample. By supplying atmospheric oxygen from the opposite side, the reaction can be rapidly advanced, and color development can be observed without removing the sample.

  Examples of the material for the porous membrane include polyesters, polyamides, polyolefins, polysulfones, and celluloses. However, the porous membrane is impregnated with an aqueous solution in which a reagent is dissolved. Or the material made hydrophilic is preferable. Hydrophilization can be performed by plasma activation, glow discharge, corona discharge, physical activation treatment such as ultraviolet irradiation, and coating of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, and the like. As a reaction reagent, an oxidative condensation reaction of 4-aminoantipyrine with the above hydrogen donor in the presence of oxidase and peroxidase is known. As will be described later, the blood absorbent member 1 is fixed to the holder 2 by adhesion or fusion.

  The holder 2 shown in FIG. 1 includes a thin tube 20, a fixing part 30 with a blood absorbing member, a fitting part 40 with a measuring instrument, and a flange 50. Each component is integrally formed by molding, but may be configured by combining different parts. The holder 2 is made of a rigid material having a predetermined rigidity. Examples of the material include acrylic resin, polystyrene, polypropylene, polyethylene, hard polyvinyl chloride, polycarbonate, ABS resin, polyester, polyphenylene sulfide (PPS), etc., but acrylic resin is used to inhale and develop blood during measurement. A highly hydrophilic material or a hydrophilic material is preferable. Hydrophilization can be performed by plasma activation, glow discharge, corona discharge, physical activation treatment such as ultraviolet irradiation, and coating of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, and the like.

  A concave groove 23 is formed on the end face 22 of the blood inlet side end 21 of the thin tube 20 shown in FIG. 2 so as not to be blocked by the skin of the blood collection site and hinder blood inhalation. The circumferential length D1 of the contact portion with the narrow tube of the groove 23 shown in FIG. 4 (a) and FIG. 4 (b) which is a cross section of the line segment II ′ is not so large as to prevent the start of blood inhalation. If the radius of the narrow tube is r, D1 ≦ 2 × π × r × 50% is desirable. The depth P of the concave groove 23 shown in FIG. 6 is 0.1 mm or more, preferably 0.2 mm to 1 mm, which does not block the tubule 20 with the skin, although it depends on the state of the skin. The shape of the ditch | groove 23 is not limited to the shape of FIG.2 and FIG.4, What is necessary is just to have a structure which does not touch skin partially. In addition, for example, a plurality of concave grooves may be formed radially around the thin tube 20 or may be formed in parallel so as to be in contact with the thin tube 20.

  On the end face 25 of the contact end 24 of the capillary tube 20 shown in FIG. 3 with the blood absorbent member, the recessed groove 26 is provided so that the inhaled blood can be smoothly spread on the blood absorbent member and an accurate measurement value can be obtained. Is forming. The depth of the concave groove 26 is not particularly limited, but is 0.01 mm or more, preferably 0.05 mm to 0.2 mm. The flat surface 27 can also be fixed by the blood-absorbing member 1 adhesion or fusion throat method. As a result, it is possible to prevent the blood absorbing member 1 from being distorted or undulated, thereby creating a gap between the end face 25 and preventing blood from being developed. The peripheral length D2 of the contact portion of the concave groove 24 shown in FIG. 5 with the narrow tube is such that the blood in the narrow tube 20 can be sucked up to the end of the contact end, and the blood absorbent member 1 and the blood are brought into contact with each other and deployed. When the radius of the narrow tube is r, D2 ≦ 2 × π × r × 50% is desirable.

  Further, as shown in FIG. 1, a gap 28 through which blood can be developed is secured between the blood-absorbing member 1 and the holder 2. The height of the gap is 0.02 mm or more, preferably 0.05 mm to 0.2 mm. The shape of the groove 26 is not limited to the shape shown in FIGS. 3 and 5, as long as it has a structure that does not partially touch the skin. In addition, for example, a plurality of concave grooves may be formed radially around the thin tube 20 or may be formed in parallel so as to be in contact with the thin tube 20. As shown in FIG. 6, the holder 2 is formed with a fixing portion 30 for fixing the blood-absorbing member 1 and a fitting portion 40 so as to be set at a fixed position with the measuring device 200.

  The measuring device 200 is known to optically measure the color intensity, convert it to a measured value and display it, or to electrically measure the potential change according to the amount of the component, convert it to a measured value, and display it. It has been. One of the error factors in such blood measurement is the individual difference in blood hematocrit. The hematocrit value is the volume of red blood cells in the blood, but it often exceeds 35% to 45% for adult women, 40% to 50% for adult men, and 60% for newborns. The difference is big. Therefore, in a test using whole blood as a specimen without separating serum, even if a certain amount of blood is supplied to the blood-absorbing member 1, the amount of serum varies, which is a measurement error factor. . Examples of tests that cause such errors include tests for serum components such as blood sugar levels, cholesterol levels, uric acid levels, creatinine levels, and inorganic ion levels such as sodium.

  The measuring device 200 discriminates the hematocrit value based on the coloration rate of the reagent, and corrects the measured value of the measurement component in the blood. The coloration speed can be obtained by measuring the difference in measured values during the measurement time. The timing of measuring the coloration speed is likely to cause a difference in speed depending on the hematocrit value. Any two points of 0 seconds and 6 seconds immediately after the start of coloration, preferably any two of 0 seconds and 4 seconds. The point is good. When there is a risk of hepatitis B, AIDS, etc. when touching the blood of a third party such as a patient, such as measurement at a hospital, the holder 2 is removed from the measuring instrument 200 as shown in FIG. 2 is provided with a protruding pin 210 on the measuring instrument 200 and a flange portion 50 on the holder, and a removing mechanism is provided. Further, although not shown, a spring mechanism or a detaching mechanism using an electromagnet may be used.

(Example 1) A holder was molded as shown in Table 1 using an acrylic resin as a material. Each holder was hydrophilized by plasma treatment under air at 0.7 torr, and a polysulfone membrane having a thickness of about 150 μm and containing no reagent was fused to the holder as a blood-absorbing member to inhale blood. The required blood volume is almost 5 μl or more than the capillary volume. After puncturing a finger, the tip of the inlet is quickly pressed against the finger from the center of about 20 μl of blood that has spouted, and the blood is spread on the polysulfone membrane. The blood inhalation was compared and confirmed. As shown in Table 2, it is clear that Sample 1 according to the present invention is excellent and that the groove is effective.

(Example 2) A holder shown in Table 3 was molded, treated in the same manner as in Example 1, impregnated with a reagent solution having the composition shown in Table 4, and dried at 40 ° C for 30 minutes. The polysulfone membrane was fused, and blood glucose level measurement was repeated about 30 times using specimens with blood glucose levels of about 100 mg / dl and 400 mg / dl. As shown in Table 2, it is clear that the sample 3 according to the present invention is excellent and the groove is effective.

(Example 3) Using the sample 3 prepared in Example 2, blood with a hematocrit value of 30%, 40%, 50%, and 60% was prepared, and glucose was added to the same blood sugar level. . The blood glucose level was measured from the reflectance every 2 seconds using a color difference meter (JASCO Corporation, Sigma 80). From Tables 6 and 7, it is possible to obtain an accurate value of the blood glucose level in the measurement time (20 seconds) from the reaction rate (difference between the 2-second value of the blood glucose level and the 0-second value) even in a short time. It should be noted that the same correction can be made for the 4 second value and others from the line graph 1 corresponding to Table 6 (FIG. 10) and the line graph 2 corresponding to Table 7 (FIG. 11). Further, specific correction values obtained from Tables 6 and 7 are shown in Table 8, and comparison with uncorrected values is shown in Table 9. The correction value in Table 8 indicates a coefficient for performing correction.

It is a longitudinal cross-sectional view of the blood test tool of this invention. FIG. 3 is an enlarged external view of the tip of a suction port of a thin tube 20. 3 is an enlarged external view of a blood absorbent member contact end of a thin tube 20. FIG. FIG. 3 is a top view of the suction port tip shown in FIG. 2. It is a top view of the blood absorptive member contact end shown in FIG. It is a schematic diagram of the use condition of a blood test tool. It is a longitudinal cross-sectional view which shows the combined state of a blood test tool and a blood test measuring device. This is an example of Japanese Unexamined Patent Application Publication No. 60-38216. This is an example of Japanese Patent Laid-Open No. 3-99265. 7 is a line graph corresponding to Table 6. 8 is a line graph corresponding to Table 7.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood absorptive member 2 Holder 20 Capillary 21 Inlet side end 22 Inlet side end face 23 Inlet side recessed groove 24 Contact end with blood absorbent member 25 Contact end face with blood absorbent member 26 Contact end face recessed groove 30 Adherence Part 40 Fitting part 50 Flange 200 Measuring instrument 210 Extrusion pin 300 Blood a Liquid analysis instrument b Reagent layer c Liquid absorption layer e Small hole A Liquid analysis instrument B Liquid absorbent member C Reagent layer D Instrument body O Capillary tube

Claims (6)

A method for obtaining a correction value of a measured value of a blood component measured using a blood test tool provided with a blood absorbing member carrying a reagent that shows a reaction with a component in blood,
A method of obtaining a correction value of a blood component measurement value for each hematocrit value based on a coloration speed obtained by measuring a difference in the measurement value during a measurement time using a blood sample having a known hematocrit value.   The method for obtaining a correction value of a blood component measurement value according to claim 1, wherein the coloration speed is a difference in measurement values between any two points between 0 seconds and 6 seconds from the start of coloration. A method for correcting a measured value of a blood component measured using a blood test tool provided with a blood absorbing member carrying a reagent that shows a reaction with a component in blood,
According to the coloration speed obtained by measuring the difference between the measurement values during the measurement time, the measurement value at the measurement time is corrected with a correction value determined in advance using a blood sample with a known hematocrit value. A method for correcting a measured value of a blood component as a feature   The blood color measurement value correction method according to claim 3, wherein the coloration speed is a difference in measurement values between any two points between 0 seconds and 6 seconds from the start of coloration. In a blood test measuring instrument that uses and sets a blood test tool provided with a blood-absorbing member carrying a reagent that shows a reaction with a component in blood,
According to the coloration speed obtained by measuring the difference between the measured values during the measurement time of the blood component, the measured value at the measured time is a correction value determined in advance using a blood sample with a known hematocrit value. A blood test measuring instrument characterized by correcting. The blood test measuring device according to claim 5, wherein the coloration speed is a difference in measured values between any two points between 0 seconds and 6 seconds from the start of coloration.

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