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WO2017006963A1 - Kit de test sanguin et procédé d'analyse l'utilisant - Google Patents

Kit de test sanguin et procédé d'analyse l'utilisant Download PDF

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Publication number
WO2017006963A1
WO2017006963A1 PCT/JP2016/070008 JP2016070008W WO2017006963A1 WO 2017006963 A1 WO2017006963 A1 WO 2017006963A1 JP 2016070008 W JP2016070008 W JP 2016070008W WO 2017006963 A1 WO2017006963 A1 WO 2017006963A1
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WO
WIPO (PCT)
Prior art keywords
blood
test kit
capillary
sample
blood sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2016/070008
Other languages
English (en)
Japanese (ja)
Inventor
光 浦野
達也 石坂
中津川　晴康
進 大澤
晋哉 杉本
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Leisure Inc Japan
Fujifilm Corp
Original Assignee
Leisure Inc Japan
Fujifilm Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Leisure Inc Japan, Fujifilm Corp filed Critical Leisure Inc Japan
Priority to CN201680039443.9A priority Critical patent/CN107864669A/zh
Priority to KR1020187000469A priority patent/KR20180016513A/ko
Priority to EP16821432.8A priority patent/EP3321677B1/fr
Priority claimed from JP2016133959A external-priority patent/JP6522556B2/ja
Publication of WO2017006963A1 publication Critical patent/WO2017006963A1/fr
Priority to US15/861,238 priority patent/US10697870B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/12—Dippers; Dredgers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard

Definitions

  • the present invention relates to a blood test kit for analyzing a target component in a blood sample and a blood analysis method using the same.
  • a general qualified blood sample is collected by a doctor or other qualified person using a syringe to collect blood from the vein, and the subject is self-collected by inserting a blood collection needle into his / her finger or the like. There is blood sampling.
  • Blood collected by general blood collection is transported to a medical institution or inspection in a state of being sealed in a collection container, where it is inspected.
  • a test is performed after blood is separated into blood cells and plasma by a centrifuge at a medical institution or inspection institution.
  • the collected blood is separated into blood cells and plasma by a separation membrane and transported to the examination site in this separated state, where the examination is performed.
  • Patent Document 1 describes a method for examining a blood sample collected by self blood collection. Specifically, 1) Prepare a sample for quantification consisting of an unknown volume of a biological sample containing a component to be quantified collected without quantifying the volume and a fixed amount of an aqueous solution containing a fixed amount of an indicator substance.
  • Patent Document 2 the amount of a component to be analyzed in a sample is measured, and further, the amount of a standard component originally present in the sample other than the above is measured.
  • a quantitative analysis method is described in which the amount of a sample is determined from the known concentrations of the standard components, and the concentration of the analysis target component in the sample is determined from the sample amount and the analysis target component amount.
  • Patent Document 3 describes that a small amount of blood is collected from a human or animal using a blood dilution quantification instrument and is supplied as it is or after dilution to supply a constant amount to another device, container or reagent.
  • Patent Document 4 describes a method of quantifying the concentration of a component to be quantified in a biological sample using the absorbance of an indicator substance in an aqueous solution for dilution.
  • Patent Document 5 discloses a hemolytic measurement method characterized by the above.
  • Patent Document 2 about 100 ⁇ L of whole blood of healthy subjects is dropped on a porous membrane, blood cells are separated and serum is developed, and then 150 ⁇ L of saline-buffered saline (pH 7.4) is added. The supernatant obtained by centrifuging the obtained liquid is analyzed as an analysis sample, but there is no description of blood collection of less than 100 ⁇ L.
  • the measurement method described in Patent Document 4 is a measurement with a dilution factor of about 10 times.
  • the measurement value is repeatedly reproduced as in Patent Document 1. There is a problem that the performance is lowered.
  • Patent Documents 1 to 4 are not sufficient for performing analysis when a very small amount of blood sample is used with high accuracy.
  • blood collection is an invasive action that damages the skin, and it may be uncomfortable to stare at the red color of the blood. It is common to want to stop the blood. For these reasons, the amount of blood collected is not always constant and often varies. If the variation in the amount of blood collected is large, the accuracy of the dilution rate will be reduced, so visualization and stabilization of the amount of blood collected is desired.
  • the problem to be solved by the present invention is to provide a blood test kit and a blood analysis method capable of performing a blood test with a small amount of blood with high accuracy by visualizing and stabilizing the blood collection volume.
  • the present inventors accommodate a blood collection device for collecting a blood sample, a diluent for diluting the collected blood sample, and a diluted blood sample.
  • a blood collection device for collecting a blood sample; A diluent for diluting the collected blood sample; A storage device for storing a dilution of a blood sample; A blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood, wherein the blood collection device is a capillary .
  • a blood collection device for collecting a blood sample; A diluent for diluting the collected blood sample; A storage device for storing a dilution of a blood sample; A blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood, The diluent contains standard components that are not present in the blood, A blood test kit, wherein the blood collection device is a capillary.
  • a blood collection device for collecting a blood sample; A diluent for diluting a collected blood sample, which contains a standard component not present in the blood; A storage device for storing a dilution of a blood sample; A blood test kit comprising: A blood test kit, wherein the blood collection device is a capillary.
  • the blood test kit includes a separation instrument for separating and collecting plasma from a diluted blood sample.
  • the scale is attached to a position indicating the lower limit of the volume range of a blood sample to be collected, and the capillary has a stopper, 7.
  • the blood test kit according to 10 wherein the inner wall of the capillary is subjected to hydrophilic treatment.
  • the blood test kit according to 10 or 11 wherein an end of the capillary on the side for sucking a blood sample has a taper.
  • At least one position indicating the volume range of the blood sample to be collected is marked on the capillary, and the inner diameter of the capillary is increased from the portion beyond the position of the scale.
  • a scale is attached to at least one position of the capillary indicating the volume range of the blood sample to be collected, and an inner diameter of a portion including the position where the scale is attached of the capillary is smaller than other portions.
  • the blood test kit according to any one of 10 to 12.
  • the blood test kit according to 1 or 2 wherein the standard component that is constantly present in blood is sodium ion or chloride ion.
  • the blood test kit according to 1 or 2 wherein the standard component that is constantly present in the blood is a standard component that is constantly present in sodium and chloride ions and still another blood.
  • the blood test kit according to 17, wherein the another standard component is total protein or albumin.
  • the blood test kit according to 2 wherein the standard component not present in the blood is lithium ion or glycerol triphosphate.
  • the blood test kit according to 3 wherein the standard component not present in the blood is lithium ion or glycerol triphosphate.
  • a method for analyzing the concentration of a target component in a blood sample excluding medical practice), characterized by using the blood test kit according to any one of 1 to 21.
  • a blood test with a very small amount of blood can be performed with high accuracy by visualizing and stabilizing the amount of blood collected.
  • FIG. 1 shows an example of the configuration of a storage device for storing a diluted blood sample.
  • FIG. 2 shows a cross-sectional view of an example of a capillary.
  • FIG. 3 shows an example of the shape of the capillary and the position of the scale.
  • FIG. 4 shows an example of the shape of the capillary and the position of the scale.
  • the range indicated by X to Y includes the upper limit X and the lower limit Y.
  • a standard component that is constantly present in blood may be referred to as an external standard substance or an external standard.
  • a standard component that does not exist in blood may be referred to as an internal standard substance or an internal standard.
  • Patent Document 2 discloses a method using a porous material having high blood retention instead of filter paper.
  • blood components absorbed in the material are extracted and measured with a buffer solution or the like, so that sodium ions, chloride ions, calcium ions, proteins, which are external standard substances that are constantly present in blood, are measured.
  • sodium ions, chloride ions, calcium ions, proteins, which are external standard substances that are constantly present in blood are measured.
  • the amount of blood collected varies, and when the dilution rate of the collected blood increases, the subsequent analysis accuracy decreases and the results vary, and the blood is agglomerated and solidified. As a result, the guarantee of the stability of the components may be insufficient.
  • a buffer solution for extracting a biological component from a dried sample it is necessary to use a buffer solution to which NaOH, NaCl, or HCl is added for pH adjustment or biological component stabilization. For this reason, the concentration of other diluted biological components is corrected using the concentration of sodium ions and chloride ions, which are present at a relatively high concentration of sample components, have homeostasis, and have small differences between individuals as an external standard. There was a problem that it could not be used to do.
  • Patent Document 1 a method described in Patent Document 1 is disclosed as a method for diluting a collected trace blood with a buffer solution containing an internal standard and quantifying the amount of a component having an unknown amount in diluted plasma from the dilution factor of the internal standard substance.
  • N- (2-Hydroxy-3-sulfopropyl) -3,5-dimethoxyaniline sodium salt (HSDA) or Acid Blue 9 (Brilliant Blue FCF) is used as an internal standard substance to stabilize blood. Buffering agents and preservatives are used for holding.
  • Such a prescription achieved the stability of its components by not coagulating the blood, but when the blood collection volume is also variable and the collection volume is small, the dilution rate of the internal standard substance after dilution This is a problem that the reliability of the test accuracy is lowered due to the decrease in the amount of blood and the amount of the blood component itself.
  • the method of diluting with a buffer solution is a biological component stored in a buffer solution with physiological conditions of pH 7.4 and is excellent in stability during transportation. There was a problem that measurement errors were likely to occur when the dilution rate was small and a small amount of sample was added.
  • phosphate buffered saline is used as the buffer solution to be extracted because it is excellent in the stable retention of biological components.
  • phosphate buffered saline contains sodium ions and chloride. Contain ions.
  • sodium ions and chloride ions cannot be used as external standards, and calcium ions, proteins, and the like are used. Therefore, in order to perform a blood test with a small amount of blood with high accuracy, the use of an external standard substance that corrects the dilution rate as in the prior art or the use of a buffer solution containing a conventionally proposed internal standard substance Insufficient inspection accuracy.
  • Patent Document 1 has a description regarding an internal standard, but there is no description regarding the combined use with an external standard. Therefore, there is no description regarding the contamination of the external standard, and no specific means for preventing the contamination has been proposed.
  • Patent Document 5 collects blood with a capillary, but is diluted with a buffer containing NaCl, and there is no description about using an external standard.
  • the present invention relates to a blood test kit and a kit for analyzing the concentration of a target component by more accurately determining the dilution factor in a method for analyzing the concentration of the target component by diluting a trace amount of blood with a buffer solution. It was made for the purpose of providing a blood analysis method. As a means for solving this problem, it is adopted that blood is collected using a capillary so that the blood collection amount is a constant value (at least equal to or greater than the allowable minimum blood collection amount). In a preferred embodiment, not only an external standard is used but also an internal standard is used.
  • the blood sample in the method of analyzing a target component in a blood sample, even if the patient collects blood himself, the blood sample can be easily set to a constant value, and at least the minimum volume range of the desired blood sample It can be more than the amount.
  • the influence of the external standard substance eluted in the buffer solution from the members constituting the kit on the calculation of the dilution ratio can be made constant, and the component to be analyzed can be accurately quantified.
  • a graduated capillary is used as an embodiment, but since the blood sampler can grasp the volume of the collected blood, it becomes possible to predict the dilution rate relatively accurately, and the dilution rate based on the measurement result It is possible to accurately estimate whether or not the calculated value is valid. For blood collectors, it is possible to visually confirm that the volume of the collected blood sample is within the allowable range and that at least the minimum amount is satisfied, so that the blood sample can be safely transported to the laboratory. There are also advantages. Further, by using a graduated capillary, the volume of the collected blood sample can be grasped, and information on the grasped volume can be provided to the testing institution together with the blood sample. The provided information can be used for checking that the calculated dilution factor is appropriate in the inspection organization.
  • the blood test kit of the present invention includes a blood collection device for collecting a blood sample, a diluent for diluting the collected blood sample, and a housing for housing a diluted blood sample.
  • Analyzing the concentration of the target component in the blood sample is to determine the concentration of the target component (that is, to quantify the target component) or whether the concentration of the target component is equal to or higher than a predetermined reference value. Including determination of whether or not, the form of analysis is not particularly limited.
  • the blood test kit of the present invention is for collecting a blood sample for analysis of a target component in the blood sample. Collection of blood using the blood test kit of the present invention may be performed by the subject himself or by a qualified person such as a doctor.
  • the patient himself / herself collects blood that has come out of the skin by damaging a fingertip or the like using an instrument with a knife such as a lancet.
  • one of the preferred embodiments of the present invention is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood.
  • using means determining the dilution factor for analyzing the concentration of the target component based on the standard value (constant value) of the standard component. Therefore, analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood is based on the constant value (standard value) of the standard component that is constantly present in blood. Is to analyze the concentration of the target component.
  • Examples of standard components that are constantly present in blood include sodium ions, chloride ions, potassium ions, magnesium ions, calcium ions, total protein, and albumin.
  • the concentration of these standard components contained in the serum and plasma of the blood sample is such that the sodium ion concentration is 134 to 146 mmol / L (average value: 142 mmol / L), and the chloride ion concentration is 97 to 107 mmol / L (average) Value: 102 mmol / L), potassium ion concentration is 3.2 to 4.8 mmol / L (average value: 4.0 mmol / L), and magnesium ion concentration is 0.75 to 1.0 mmol / L (average value: 0.9 mmol / L), calcium ion concentration is 4.2 to 5.1 mmol / L (average value: 4.65 mmol / L), and total protein concentration is 6.7 to 8.3 g / 100 ml (average value: 7.5 g / 100 mL), and the albumin concentration
  • the present invention is intended to enable measurement of a target component when the amount of blood collected to relieve pain of a patient is very small.
  • a very small amount of blood is diluted with a diluent, It is necessary to accurately measure the concentration of “a standard component that is continually present in blood”.
  • the concentration of components originally present in the blood decreases in the diluted solution, and depending on the dilution rate, there is a possibility that a measurement error is included in the concentration measurement. Therefore, in order to detect the above-mentioned standard component with sufficient accuracy when a very small amount of blood component is diluted at a high dilution rate, it is preferable to measure a standard component present at a high concentration in a very small amount of blood.
  • sodium ions Na +
  • chloride ions Cl ⁇
  • sodium ion having the highest amount in the blood among the standard components that are constantly present in the blood.
  • the average value of sodium ion represents a standard value (median value of the reference range), and the value is 142 mmol / L, which accounts for 90 mol% or more of the total cations in plasma.
  • One preferred embodiment of the present invention is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is not present in blood.
  • a test kit may be used for using a standard component that does not exist in blood together with a standard component that exists constantly in blood, and does not use a standard component that exists constantly in blood.
  • a standard component that does not exist in blood may be used alone.
  • standard components that are not present in the blood can be used by adding them to a diluting solution described later so as to have a predetermined concentration.
  • a substance that is not contained at all in the blood sample or is contained in a trace amount even if it is contained can be used.
  • Standard components that are not present in blood include substances that do not interfere with the measurement of target components in blood samples, substances that do not degrade due to the action of biological enzymes in blood samples, substances that are stable in dilution, and blood cell membranes. It is preferable to use a substance that does not permeate and is not contained in blood cells, a substance that does not adsorb to a buffer storage container, and a substance that can use a detection system that can measure with high accuracy.
  • a substance that is stable even if stored for a long time in a state of being added to a diluent is preferable.
  • standard components not present in blood include glycerol triphosphate, alkali metals Li, Rb, Cs, or Fr, and alkaline earth metals Sr, Ba, or Ra, and Li and glycerol tris. Phosphoric acid is preferred.
  • These standard components that are not present in blood can be colored by adding a second reagent during concentration measurement after blood dilution, and the concentration in the diluted blood can be determined from the color density.
  • concentration in the diluted blood can be determined from the color density.
  • the measurement of lithium ions added to the diluting solution is performed by biochemistry using a chelate colorimetric method (halogenated porphyrin chelate method: perfluoro-5,10,15,20-tetraphenyl-21H, 23H-porphyrin).
  • a chelate colorimetric method halogenated porphyrin chelate method: perfluoro-5,10,15,20-tetraphenyl-21H, 23H-porphyrin.
  • the blood test kit of the present invention includes a diluent for diluting the collected blood sample.
  • Diluent does not contain standard components that are permanently present in the blood if the kit is used to analyze the concentration of the component of interest in the blood sample using standard components that are permanently present in the blood .
  • “Not contained” means “not substantially contained”.
  • substantially does not contain means that it does not contain a substance having homeostasis used at the time of determining the dilution factor, or even if it is contained, the homeostasis of the diluted solution after diluting the blood sample It means a case where it is contained at a very small concentration that does not affect the measurement of a toxic substance.
  • sodium ions or chloride ions are used as a standard component that is constantly present in blood, a diluent that does not substantially contain sodium ions or chloride ions is used as the diluent.
  • the diluted solution is pH 6.5 to pH 8.0 in order to prevent decomposition and denaturation of the target component.
  • the buffer solution has a buffering action in the pH range of pH 7.0 to pH 7.5, more preferably pH 7.3 to pH 7.4, and the diluent contains a buffer component that suppresses fluctuations in pH. It is preferable to use a buffer solution.
  • buffer types include acetate buffer (Na), phosphate buffer (Na), citrate buffer (Na), borate buffer (Na), tartrate buffer (Na), Tris (Tris).
  • (Hydroxymethyl) aminoethane) buffer (Cl) Hepes ([2- [4- (2-hydroxyethyl) -1-piperazinyl] ethanesulfonic acid]) buffer, phosphate buffered saline (Na), etc.
  • phosphate buffers, Tris buffers, and Hepes buffers are representative examples of buffers around pH 7.0 to pH 8.0.
  • the phosphate buffer contains a sodium salt of phosphate
  • the Tris buffer has a dissociated pKa of 8.08, so that it has a buffer capacity around pH 7.0 to pH 8.0.
  • the buffer solution used does not contain sodium ions or chloride ions (included)
  • a buffer is preferably selected from the group consisting of 2-amino-2-methyl-1-propanol (AMP), 2-ethylaminoethanol, N-methyl-D-glucamine, diethanolamine, and triethanolamine.
  • AMP 2-amino-2-methyl-1-propanol
  • 2-ethylaminoethanol N-methyl-D-glucamine
  • diethanolamine diethanolamine
  • triethanolamine triethanolamine.
  • 2- [4- (2-hydroxyethyl-1-piperazinyl] ethane also referred to as HEPES, which is a Good's buffer (Good buffer) and has a pKa of around 7.4.
  • BES N, N-bis (2-hydroxyethyl)
  • a diluent containing a buffer selected from the group consisting of -2-aminoethanesulfonic acid (pKa 7.15), among which 2-amino-2-methyl-1-propanol (AMP) and HEPES, A combination with TES, MOPS or BES is preferable, and a combination of 2-amino-2-methyl-1-propanol (AMP) and HEPES is most preferable, where pKa represents an acid dissociation constant.
  • the concentration ratio of amino alcohol and Good's buffer solution is 1: 2 to 2: 1, preferably 1: 1.5 to 1.5: 1, more preferably 1: 1.
  • the concentration of the buffer is not limited, but the concentration of amino alcohol or Good's buffer is 0.1 to 1000 mmol / L, preferably 1 to 500 mmol / L, more preferably 10 to 100 mmol / L.
  • the buffer solution may contain a chelating agent, a surfactant, an antibacterial agent, a preservative, a coenzyme, a saccharide and the like for the purpose of keeping the analysis target component stable.
  • a chelating agent include ethylenediaminetetraacetic acid (EDTA) salt, citrate, and oxalate.
  • the surfactant include a cationic surfactant, an anionic surfactant, an amphoteric surfactant, and a nonionic surfactant.
  • the preservative include sodium azide and an antimicrobial substance.
  • the coenzyme include pyridoxal phosphate, magnesium, zinc and the like.
  • saccharide of the erythrocyte stabilizer examples include mannitol, dextrose, oligosaccharide and the like.
  • by adding antibiotics it is possible to suppress the growth of bacteria partially mixed from the finger surface at the time of hand blood collection, to suppress the degradation of the biological components by bacteria, and to stabilize the biological components.
  • the buffer also contains a standard component that is not present in blood in a kit for analyzing a target component using a standard component that is not present in blood. It is also important not to include an internal standard substance, which will be described later, and not to interfere with the blood analysis measurement system.
  • the osmotic pressure of the buffer solution is equivalent to that of blood (285 mOsm / kg (mOsm / kg is the osmotic pressure of 1 kg of water in the solution and represents the number of millimolar ions)) or more By doing so, hemolysis of blood cells can be prevented.
  • the osmotic pressure can be adjusted to be isotonic with salts, sugars, buffers or the like that do not affect the measurement of the target component and the measurement of the standard component that is constantly present in the blood.
  • the osmotic pressure of the buffer solution can be measured with an osmometer.
  • ALT alanine transaminase
  • AST anaspartate aminotransferase
  • ⁇ -GTP ⁇ glutamyl transpeptidase
  • ALP alkaline phosphatase
  • total bilirubin The concentration in the blood of several or more substances such as total protein and albumin is measured.
  • a certain amount of diluted blood is required in consideration of the possibility of remeasurement. Therefore, it is important to secure a certain amount of the diluent for diluting the collected blood. Considering that blood is collected with low invasiveness as much as possible, it is desirable to avoid a blood collection volume of 100 ⁇ L or more, and therefore the dilution factor is about 7 times or more.
  • the kit of the present invention employs a capillary as a blood collection device.
  • a capillary as a blood collection device.
  • a sufficient amount of blood sample specifically, If about 100 ⁇ L, the dilution factor can be calculated with high accuracy.
  • the dilution ratio when calculating the dilution ratio using an external standard substance, if the blood volume is small, the dilution ratio will be high, and it will be easily affected by contamination of the external standard substance that is eluted from the kit components during dilution. The measurement accuracy is reduced.
  • the present inventors have analyzed a concentration of a component by diluting a trace amount of blood sample with a diluent, and, for example, an external standard substance that has a blood collection amount not exceeding 100 ⁇ L and elutes from a member into the diluent.
  • a diluent for example, an external standard substance that has a blood collection amount not exceeding 100 ⁇ L and elutes from a member into the diluent.
  • FIG. 2 is a cross-sectional view of an embodiment of a capillary according to the present invention.
  • the capillary is usually a tube composed of a thin cylindrical body 201 having a substantially constant inner diameter.
  • a capillary phenomenon a phenomenon in which liquid permeates into the capillary against gravity.
  • the other end of the capillary blood sampling device is sealed with a finger or the like, and suction is stopped.
  • the capillary holding the blood sample with the end held with a finger is carried to a storage device that stores a diluent for diluting the blood sample. Then, after holding one end of the capillary in the storage device, the finger holding the end is released, and the blood sample is stored in the storage device.
  • the capillaries may be sealed using a sealer such as a cap, a silicon putty or a paraffin resin, clay, or the like, instead of being pressed with a finger and sealed.
  • the inner diameter of the capillary is preferably 0.5 to 2.0 mm in consideration of the size of blood cells and the occurrence of capillary action.
  • the length of the capillary is preferably 5 to 15 cm in consideration of ease of handling and the like, and is preferably 5 to 10 cm because it is desirable to be compact in consideration of constituting a blood test kit. More preferred.
  • the volume of blood that can be collected with a capillary for example, when the inner diameter is 1.1 mm to 1.2 mm and the length is 7.5 cm, 70 ⁇ L of blood can be collected.
  • FIG. 3 shows an example of a capillary with a scale for confirming the volume of the collected blood sample.
  • the maximum volume of a blood sample that can be collected by a capillary is theoretically the amount that fills the inside of the capillary, but the capillary indicates the position and upper limit that indicate the lower limit of the volume range of the collected blood sample.
  • the position can be provided with a lower limit scale 204 and an upper limit scale 205, whereby it can be determined whether or not the volume of the collected blood sample is appropriate. For example, when it is preferable to collect a blood sample at about 65 ⁇ L, it is preferable to calibrate 55 ⁇ L and 75 ⁇ L, which are ⁇ 10 ⁇ L.
  • the volume range of the blood sample to be collected is the volume range of the blood sample that is allowed to accurately analyze the target component contained in the blood sample. In the above example, the volume range is 55 to 75 ⁇ L.
  • the inner diameter of the portion including the position where the capillaries are marked may be smaller than other portions. This is because the volume can be collected more accurately if there is a scale in a portion having a small inner diameter, that is, a portion where the tube is thin. Moreover, since the rising speed of the blood in the capillary is increased by reducing the inner diameter, it is easy to take the sealing timing.
  • the scale 4 attached to the position indicating the lower limit affects the inspection accuracy if it is less than this, it is preferable that the scale line is thick and easy to see.
  • the blood sampler can also reduce the risk that the blood contact end 212 for contacting the blood in the capillary will be mistaken for the sealing end 213 which is the other end.
  • blood collection exceeding the upper limit tends to suppress the influence of contamination of the external standard substance from the member, but the variation tends to increase as compared with the case where the blood collection amount is close to the lower limit.
  • a stopper with a hole is provided inside the position indicating the upper limit of the capillary (for example, the upper limit scale 205 in FIG. 3), and blood reaches this stopper.
  • the suction may be stopped by sealing the upper end of the capillary with a finger or the like.
  • the inner diameter of the end 212 on the side of the capillary that comes into contact with blood may be made smaller than that of other portions. As a result, capillary action can easily occur.
  • the end portion 207 on the side of the capillary that comes into contact with blood may be a tapered type whose inner diameter becomes smaller toward the end.
  • the capillary can be shaped to collect a blood sample of a defined volume.
  • An example of such a capillary is designed to have a defined capacity when the interior is filled with a blood sample.
  • the shape cannot be collected any more.
  • the inner diameter is changed from a certain position of the capillary. The size is rapidly increased (for example, the inner diameter exceeds 2 mm), and the capillary phenomenon hardly occurs when the position is exceeded.
  • the change in capacity with respect to the scale deviation is reduced, and the measurement accuracy can be increased.
  • the capillary having such a shape may be graduated at a position indicating the upper limit or the lower limit of the blood volume to be collected.
  • the position for changing the inner diameter can be a position with a scale or a position beyond the scale, but the latter is preferable when the inner diameter is increased. This is because if there is a scale in the narrow part of the tube before the inner diameter increases, the capacity can be judged accurately.
  • the position beyond the scale means a position showing a volume increased by 1 ⁇ L to 7 ⁇ L, preferably 3 ⁇ L to 5 ⁇ L from the volume when the scale is collected.
  • the capillary used in the present invention preferably has an anticoagulant inside when blood obtained by puncturing with a lancet or the like is directly collected by the capillary.
  • An example of such a capillary is one in which an anticoagulant such as heparin or EDTA salt is applied to the inner surface of the capillary.
  • Various anticoagulants can be used, but when an external standard is used in the analysis, one that does not substantially contain the external standard is selected.
  • the capillary used in the present invention may be made of glass or synthetic resin. In addition, other materials may be coated with a synthetic resin. In this specification, plastic is used synonymously with synthetic resin.
  • the capillaries are preferably made of plastic from the viewpoint of safety that damage is less likely to occur than glass. For example, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polystyrene, polyvinyl acetate, polyurethane, acrylonitrile butadiene styrene resin (ABS resin), acrylonitrile styrene resin (AS resin), acrylic resin (PMMA), polycarbonate, silicone resin, etc. Is mentioned.
  • the water contact angle of the glass is 10 degrees or less, so that the inner wall of the capillary is sufficiently hydrophilic even if it is intact, and the capillary action of the capillary is sufficiently exhibited and blood can be collected quickly.
  • the capillary is made of plastic, for example, the water contact angle of polycarbonate is 85 degrees, and the water contact angle of acrylic is 70 degrees.
  • the inner wall of the capillary is preferably treated to be hydrophilic.
  • hydrophilic treatment for example, hydrophilic treatment by plasma treatment is possible.
  • the capillary for collecting blood used by medical professionals and researchers is transparent, but one of the preferred embodiments of the capillary used in the present invention is colored so that the red color of blood is not noticeable. It is a thing. If the capillary is made of plastic, coloring is easy. Alternatively, although the capillary is transparent, glasses or the like using a transmission medium capable of shielding the absorption wavelength region of hemoglobin in the blood so that the collected blood looks a color other than red is one of the components of the blood test kit. It's okay.
  • hemoglobin combined with oxygen looks red, but it is difficult to absorb sharply from the wavelength 600 nm toward the long wavelength side. Therefore, for example, by using a filter that absorbs wavelengths longer than 680 nm, the red color of blood can be made inconspicuous (looks like an orange color).
  • kits for separating and collecting plasma from diluted blood samples A blood sample collected by the kit of the present invention may elapse for a long time in a diluted state until analysis is performed. In the meantime, for example, when hemolysis of erythrocytes occurs, substances or enzymes present in the blood cells elute into the plasma or serum and affect the test results, or the absorption of the eluted hemoglobin causes the optical properties of the analyte to be analyzed. This may have an impact on the measurement of the amount of analysis target components using optical information such as typical absorption. Therefore, it is preferable to prevent hemolysis. Therefore, it is preferable that the kit includes a separation device for separating and collecting plasma from a diluted blood sample.
  • a preferred example of the separation device is a separation membrane.
  • the separation membrane can be used, for example, by applying pressure to a diluted blood sample to capture blood cell components with the separation membrane, allowing plasma components to pass through, separating blood cells, and collecting plasma components.
  • an anticoagulant it is preferable to use an anticoagulant.
  • the plasma that has passed through the separation membrane does not flow back to the blood cell side.
  • a backflow prevention means described in JP-A-2003-270239 is used. It can be a component of a kit.
  • the kit of the present invention makes it possible to realize a method capable of analyzing a component to be analyzed with high measurement accuracy even with a blood collection volume of 100 ⁇ L or less, and to accurately measure a patient with a small blood collection volume of 100 ⁇ L or less. It is preferable that the kit includes an instruction manual in which information such as the possibility of blood collection and to which position of the capillary the blood should be collected is described.
  • the kit is not only a capillary but also a diluent, a first storage device containing the diluent (also a storage device for storing a diluted blood sample), and diluted with the diluent.
  • Separation device for separating and recovering plasma from the collected blood sample holding device for holding the separation device, second storage device for storing the collected plasma, and the stored plasma in the second storage device Including a sealing device for maintaining
  • FIG. 1 of Japanese Patent No. 3597827 is incorporated as FIG. 1 of the present application.
  • the blood separation device 1 includes a blood collection container 2 (a storage device in which a diluent is stored, or a first storage device. It is also a storage device for storing a diluted blood sample) and a blood collection container 2.
  • a cylindrical body 3 that can be inserted (second storage device for storing the collected plasma), a cap piston 4 that can be attached to the cylindrical body 3, and a sealing lid 5 provided at the lower end of the cap piston 4 ( Before use, the upper end opening of the blood collection container 2 is sealed with a cap 6 via a packing 7 before use.
  • the storage device for storing the diluted blood sample in the present invention corresponds to the combination of the blood collection container 2 and the cylinder 3 in the configuration of FIG. That is, the number of storage devices for storing the diluted blood sample may be one or a combination of two or more.
  • the blood collection container 2 is made of a transparent material and has a cylindrical shape.
  • a screw portion 8 is formed on the outer surface of the blood collection container 2 and an engaging portion 9 is projected on the inner surface.
  • an inverted conical bottom portion 10 is formed at the lower end portion of the blood collection container 2, and a cylindrical leg portion 11 is formed around the bottom portion 10.
  • the legs 11 have the same outer diameter as the sample cup used at the time of blood analysis and testing, and preferably, slit grooves 12 are formed in the vertical direction at positions opposite to the lower ends thereof. Further, as shown in FIG. 1, a required amount, for example, a diluted solution 13 of 500 mm 3 may be placed in the blood collection container 2 in advance.
  • the cylindrical body 3 is made of a transparent material and has a cylindrical shape, and an enlarged diameter portion 14 is formed at an upper end portion thereof.
  • the enlarged diameter portion 14 is connected to the main body portion 16 through a thin portion 15.
  • a reduced diameter portion 18 is formed at the lower end of the cylindrical body 3, and a locking projection 19 is formed on the inner surface of the reduced diameter portion 18.
  • the outer flange portion 20 (holding device) is formed at the lower end portion of the reduced diameter portion 18, the lower end opening portion of the outer flange portion 20 is covered with a filtration membrane 21 (separation device), and the filtration membrane 21 is in the blood. It allows passage of plasma and prevents passage of blood cells.
  • a silicon rubber cover 22 is attached to the outer periphery of the reduced diameter portion 18 (FIG. 1).
  • the cap piston 4 includes a substantially cylindrical knob 26 and a mandrel 27 that is concentric with the knob 26 and extends downward.
  • a cylindrical space 28 into which the enlarged diameter portion 14 of the cylindrical body 3 can be fitted is formed at the inner upper end portion of the knob portion 26, and the lower portion thereof is screwed and can be screwed into the screw.
  • the lower end portion 29 of the mandrel portion 27 is formed in a pin shape, and the sealing lid 5 is detachably provided on the lower end portion 29 (see FIG. 1).
  • the sealing lid 5 is made of silicon rubber.
  • the operation of separating and collecting plasma from a diluted blood sample is performed as follows. After the blood collected by the capillary is put into the blood collection container 2 containing the dilution liquid, the blood and the dilution liquid are sufficiently shaken and mixed while taking care not to foam by holding the upper part of the blood collection container 2. Next, the cylindrical body 3 holding the filtration membrane 21 (preventing liquid leakage due to sneaking into the side surface of the cylinder when separating blood plasma and blood cells) is inserted into the blood collection container 2 so that the filtration membrane is below, and slowly and constantly The filtration membrane is pushed down to the bottom of the blood collection container 2 at a speed.
  • the number of each element included in the blood test kit of the present invention is not particularly limited, and may be one each or two or more.
  • the material of the members other than the capillary included in the blood test kit of the present invention is preferably a synthetic resin from the viewpoint of resistance to breakage, hygiene, and cost.
  • a synthetic resin for example, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polystyrene, polyvinyl acetate, polyurethane, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene resin (ABS resin), acrylonitrile styrene resin (AS resin), acrylic resin (PMMA) , Polycarbonate, silicone resin and the like.
  • the blood test kit of the present invention stores a capillary, a diluent for diluting a blood sample, a storage device for storing the diluted blood sample, and optional elements described above if desired. It can provide as a form stored in a storage container.
  • the present invention also provides a blood analysis method using the kit having the configuration described in [1] above.
  • the blood analysis method includes a mode that is a medical act on a human (an act performed by a doctor) and a mode that is not a medical act on a human (for example, a mode in which a blood sampler is a patient himself and an analyst is a person other than a doctor, Embodiments for human animals, etc.).
  • the blood analysis method of the present invention may be performed by self-collection in which the subject himself collects blood, or may be performed in general blood collection in which a qualified person such as a doctor collects blood using a syringe. Good.
  • the patient himself / herself collects the blood that has come out of the skin by damaging a fingertip or the like using an instrument with a knife such as a lancet.
  • the biological sample to be analyzed is blood
  • blood is a concept including serum or plasma.
  • plasma or serum obtained by collecting a small amount of blood from a subject, diluting with a buffer solution, and then separating blood cells by a filter or centrifugation can be used.
  • the component of the blood sample is preferably a plasma component separated from the blood sample by the separation means.
  • the origin of the blood sample is not limited to humans, but may be mammals, birds, fishes, etc., which are non-human animals (non-human animals). Examples of animals other than humans include horses, cows, pigs, sheep, goats, dogs, cats, mice, bears, pandas, and the like.
  • the source of the biological sample is human.
  • the concentration of a target component is analyzed using a standard component that is constantly present in a blood sample.
  • a standard component that is constantly present in a blood sample.
  • the description in [1] applies here as it is.
  • the occupation ratio of plasma components in the blood of the subject is about 55% in terms of volume, but varies depending on changes in the amount of salt intake of the subject. Therefore, in the present invention, the dilution ratio of plasma is calculated using the standard value of the standard component that is constantly present in plasma, and the concentration of the target component in plasma in the blood sample is calculated using the calculated dilution ratio. analyse.
  • the dilution factor can be obtained by calculating the dilution factor (Y / X) of the plasma component in the blood sample from the known concentration value (concentration Y; 142 mmol / L in the case of sodium ion) of ions, etc. . Using this dilution factor, the measurement value (concentration Z) of the target component in the plasma dilution is measured, and this measurement value is multiplied by the dilution factor, so that the analyte actually contained in the plasma of the blood sample The component concentration [Z ⁇ (Y / X)] can be measured.
  • the concentration of sodium ion or the like can be measured by, for example, flame photometry, glass electrode method, titration method, ion selective electrode method, enzyme activity method and the like.
  • the measurement of sodium ion utilizes the fact that ⁇ -galactosidase is activated by sodium ion, and uses the proportional relationship between sodium ion concentration and galactosidase activity in a sample diluted with a buffer solution. Measurement method is adopted.
  • a dilution factor independently from the other standard components and confirm that the value matches the dilution factor obtained above.
  • the coincidence means that in two measured values (a, b), the ratio of their difference to their average value, that is,
  • a standard component that is constantly present in plasma other than sodium ions or chloride ions it is preferably selected from total protein or albumin, and more preferably total protein.
  • Methods for measuring total protein include known methods such as the Burette method, the ultraviolet absorption method, the Breadford method, the Raleigh method, the bicinchoninic acid (BCA) method, and the fluorescence method.
  • a method to be used as appropriate can be selected according to the amount and the like.
  • the concentration of the target component is analyzed using standard components that are not present in the blood.
  • a blood test kit containing a diluent containing standard components not present in blood is used.
  • the concentration of the target component is analyzed using a standard component that is constantly present in blood and a standard component that is not present in blood.
  • the dilution ratio of the blood sample is determined by using sodium ion as a standard component that is constantly present in the blood and lithium ion as a standard component that is not present in the blood.
  • the measurement of sodium ion is proportional to ⁇ -galactosidase activity.
  • it can be calculated by any one of the following formulas 1 to 4.
  • A, B, C, D, B ′ and X are defined as follows.
  • the blood sample component is calculated by calculating with Equation 5 using the root-mean-square method, and multiplying the concentration of the analysis target component in the diluted solution by the dilution rate calculated with Equation 5.
  • An embodiment in which the concentration of the target component is analyzed is also preferable.
  • the concentration of the target component in the blood sample component can be calculated from the concentration of the target component in the diluent based on the dilution factor.
  • the analysis target component is not limited, and any substance contained in a biological sample is targeted. Examples include biochemical test items in blood used for clinical diagnosis, markers for various diseases such as tumor markers and hepatitis markers, and include proteins, sugars, lipids, low molecular weight compounds, and the like. Further, the measurement includes not only the substance concentration but also the activity of substances having an activity such as an enzyme. Each target component can be measured by a known method.
  • Dilution liquid was prepared with the following composition.
  • osmotic pressure a value measured using OSMOATAT OM-6040 (manufactured by ARKRAY, Inc.) was displayed.
  • the unit of osmotic pressure is the osmotic pressure of 1 kg of solution water, and represents the number of millimoles of ions.
  • HEPES 50mmol / L 2-Amino-2-methyl-1-propanol (AMP) 50mmol / L D-mannitol 284 mmol / L Lithium chloride 1mmol / L EDTA-2K 0.8mmol / L PALP (pyridoxal phosphate) 0.05mmol / L Thiabendazole 0.0001 mass% Amikacin sulfate 0.0003 mass% Kanamycin sulfate 0.0005% by mass Meropenem trihydrate 0.0005% by mass Osmotic pressure 355mOsm / kg pH 7.4
  • the sodium ion concentration was measured for each diluted solution prepared in (1).
  • ⁇ -galactosidase was activated by sodium ions, and the enzyme activity method was used that utilized a proportional relationship between the sodium ion concentration in each dilution and ⁇ -galactosidase activity. Specifically, after diluting the diluted blood solution 5 times with purified water not containing sodium ions, 3 ⁇ L was weighed, 52 ⁇ L of the first reagent prepared as follows was added, and the mixture was heated at 37 ° C. for 5 minutes.
  • the temperature was determined by measuring the absorbance at a main wavelength of 545 nm and a sub wavelength of 596 nm using a JCA-BM6050 type biochemical automatic analyzer (manufactured by JEOL Ltd.). .
  • the concentration of lithium ions was measured from a calibration curve prepared in advance.
  • a lithium ion measuring reagent having the following composition was prepared.
  • Reference Example 2 80 ⁇ L of blood prepared in Reference Example 1 was weighed with a capillary, mixed with a diluting solution, and a blood plasma component was separated with a filter, and then the total protein concentration was measured by the method described below.
  • the average value of the dilution rate determined from the total protein concentration was the same as the average dilution rate determined from the sodium ion concentration prepared in Reference Example 1. Thereby, it turned out that it can verify that the measurement of the dilution rate calculated

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Abstract

La présente invention aborde le problème de la fourniture d'un kit de test sanguin, par lequel la quantité de collecte de sang est visualisée et uniformisée de telle sorte qu'un test sanguin peut être effectué avec une précision élevée à l'aide d'une quantité mineure de sang, et un procédé d'analyse de sang. L'invention concerne un kit de test sanguin pour analyser la concentration d'un composé cible dans un échantillon de sang à l'aide d'un composé standard existant en permanence dans le sang, ledit kit de test sanguin comprenant un dispositif de collecte de sang pour collecter un échantillon de sang, un diluant pour diluer l'échantillon de sang collecté, et un dispositif de logement pour recevoir l'échantillon de sang dilué, le dispositif de collecte de sang étant un capillaire.
PCT/JP2016/070008 2015-07-06 2016-07-06 Kit de test sanguin et procédé d'analyse l'utilisant Ceased WO2017006963A1 (fr)

Priority Applications (4)

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CN201680039443.9A CN107864669A (zh) 2015-07-06 2016-07-06 血液检查试剂盒及使用血液检查试剂盒的分析方法
KR1020187000469A KR20180016513A (ko) 2015-07-06 2016-07-06 혈액 검사 키트, 및 그것을 이용한 분석 방법
EP16821432.8A EP3321677B1 (fr) 2015-07-06 2016-07-06 Kit de test sanguin et procédé d'analyse l'utilisant
US15/861,238 US10697870B2 (en) 2015-07-06 2018-01-03 Blood test kit and analyzing method using the same

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JP2016133959A JP6522556B2 (ja) 2015-07-06 2016-07-06 血液検査キット、及びそれを用いた分析方法

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CN107760673A (zh) * 2017-08-25 2018-03-06 南通普惠精准医疗科技有限公司 游离dna的稳定剂和用于游离dna检测的采血管
WO2018216607A1 (fr) * 2017-05-22 2018-11-29 Okinawa Institute Of Science And Technology School Corporation Système intégré d'échantillonnage et de traitement de suspension liquide
JP2019200085A (ja) * 2018-05-15 2019-11-21 富士フイルム株式会社 血液検体案内器具、及び血液検査キット
US20210010998A1 (en) * 2018-03-28 2021-01-14 Fujifilm Corporation Sample acquisition information management device, sample acquisition information management system, and sample acquisition information management method

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WO2018216607A1 (fr) * 2017-05-22 2018-11-29 Okinawa Institute Of Science And Technology School Corporation Système intégré d'échantillonnage et de traitement de suspension liquide
CN107760673A (zh) * 2017-08-25 2018-03-06 南通普惠精准医疗科技有限公司 游离dna的稳定剂和用于游离dna检测的采血管
CN107760673B (zh) * 2017-08-25 2020-08-07 南通普惠精准医疗科技有限公司 游离dna的稳定剂和用于游离dna检测的采血管
US20210010998A1 (en) * 2018-03-28 2021-01-14 Fujifilm Corporation Sample acquisition information management device, sample acquisition information management system, and sample acquisition information management method
US12254608B2 (en) * 2018-03-28 2025-03-18 Fujifilm Corporation Sample acquisition information management device, sample acquisition information management system, and sample acquisition information management method
JP2019200085A (ja) * 2018-05-15 2019-11-21 富士フイルム株式会社 血液検体案内器具、及び血液検査キット
WO2019220938A1 (fr) * 2018-05-15 2019-11-21 富士フイルム株式会社 Instrument de guidage d'échantillon sanguin et kit pour analyse de sang

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