WO2011102563A1 - Dispositif de dosage immunologique et procédé de dosage immunologique l'utilisant - Google Patents

Dispositif de dosage immunologique et procédé de dosage immunologique l'utilisant Download PDF

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Publication number
WO2011102563A1
WO2011102563A1 PCT/KR2010/000972 KR2010000972W WO2011102563A1 WO 2011102563 A1 WO2011102563 A1 WO 2011102563A1 KR 2010000972 W KR2010000972 W KR 2010000972W WO 2011102563 A1 WO2011102563 A1 WO 2011102563A1
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WIPO (PCT)
Prior art keywords
sample
detector
chamber
membrane
buffer
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PCT/KR2010/000972
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English (en)
Korean (ko)
Inventor
조영식
조병기
김정호
김재영
한승목
Original Assignee
주식회사 에스디
국방과학연구소
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Priority to PCT/KR2010/000972 priority Critical patent/WO2011102563A1/fr
Publication of WO2011102563A1 publication Critical patent/WO2011102563A1/fr

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    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G01N33/54389—Immunochromatographic test strips based on lateral flow with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones

Definitions

  • the present invention relates to an immunoassay device and an immunoassay method using the same, and more particularly, to use a single membrane strip, which can improve the accuracy of sample analysis by maintaining a constant amount of absorption and antigen-antibody reaction time of the sample. It relates to an immunoassay device and an immunoassay method using the same.
  • Immunochromatography also known as rapid test, is a method that can qualitatively and qualitatively examine trace analytes in a short time by using antigen-antibody reactions. It is used in various fields such as medicine, agriculture, animal husbandry, food, military and environment.
  • an assay device in the form of an assay strip or a device in which the assay strip is mounted inside a plastic case is generally used.
  • 1 is a cross-sectional view of an assay strip used for conventional immunochromatographic analysis, as shown in FIG. 1, a conventional assay strip 10 using a sample pad 12, a naked eye or a sensor containing a liquid sample.
  • such a conventional assay strip 10 has overlapping pads, and the hygroscopic pad 18 continues to induce absorption of the sample and the liquid buffer, so that the test line depends on the amount of the sample and the liquid buffer introduced.
  • There may be a signal difference such as a difference in color of the capturer 16a, or the signal may increase over time.
  • the detector which is fixed in the detector pad 14 in a dried form, is mixed with the liquid sample moved to the capillary phenomenon, the mixing with the detector may not be uniform and deviation may occur for each strip 10. There is a concern that the accuracy of qualitative and quantitative sample analysis may be degraded.
  • an object of the present invention to provide an immunoassay device and an immunoassay method using the same, which can adjust the amount of absorption and antigen-antibody reaction time of a sample and increase the accuracy of the sample analysis.
  • one or more membrane strips including a porous membrane formed with a test line fixed to the trapping agent to bind to the analyte and / or detector and the antigen-antibody reaction in the sample;
  • An upper case covering an upper portion of the membrane strip and having a sample inlet and a result confirmation window;
  • a lower case covering a lower portion of the membrane strip and having a sample reservoir formed thereon;
  • an immunoassay device comprising a sample pre-treatment device for mixing the sample, the liquid buffer and the detector into the sample reservoir.
  • the present invention comprises the steps of inserting a detector pad in the sample and detector receiving portion of the sample pretreatment device, and sucking the sample into the capillary of the sample and the detector receiving portion; Inserting the sample and detector receiver into a buffer receiver of a sample pretreatment device, and mixing the sample, the detector and the liquid buffer to form a pretreated sample; Moving the pretreated sample through the membrane strip; And detecting an analyte of the pretreated sample having passed the test line of the membrane strip by an antigen-antibody reaction.
  • the membrane strip may be adjusted to arbitrarily adjust the speed and antigen-antibody reaction time of moving a mobile phase such as a sample by adjusting the length of the membrane strip.
  • a mobile phase such as a sample
  • the pad By incorporating the pad into the sample pretreatment device, it is possible to mix a certain amount of sample, detector and liquid phase buffer, and to make the mixture of the sample and the detector homogeneous. Therefore, it is possible to improve the accuracy of the sample analysis by keeping the absorption amount of the sample and the detector and the antigen-antibody reaction time constant, and is useful for an analytical device using an immunochromatographic assay such as glycated hemoglobin measurement.
  • FIG. 1 is a cross-sectional view of an assay strip used in a conventional immunoassay device.
  • Figure 2 is an exploded perspective view of the immunoassay device according to an embodiment of the present invention.
  • Figure 3 is an enlarged bottom view of the three-dimensional structure (projection) formed in the upper case of the immunoassay device according to an embodiment of the present invention.
  • Figure 4 is an exploded perspective and side cross-sectional view of a sample pretreatment apparatus according to an embodiment of the present invention.
  • FIG. 5 is a perspective view of an upper case and a lower case of an immunoassay device according to another embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of an immunoassay device according to an embodiment of the present invention
  • FIG. 4 is an exploded perspective view and a side cross-sectional view of a sample pretreatment device according to the present invention.
  • the immunoassay device according to the present invention for qualitative and quantitative testing of a sample that can be detected by immunochromatography, an analyte and / or detector in the sample ( one or more membrane strips 30 comprising a porous membrane 32 having a detector line fixed with a detector (antigen, antibody or other ligand) that binds to a detector and an antigen-antibody reaction, said membrane
  • the upper case 40 covers the upper part of the strip 30, the upper case 40 in which the sample inlet 42 and the result confirmation window 44 are formed, and the lower part of the membrane strip 30.
  • a lower case 50 is formed, and a sample pretreatment device (FIG. 4) for mixing the sample, the liquid buffer, and the detector into the sample reservoir 52.
  • the immunoassay device according to the present invention may be composed only of the membrane strip 30 and the sample pretreatment device.
  • the membrane strip 30 used in the present invention includes a porous membrane 32 in which a solution such as the sample moves to a capillary phenomenon so that the test line 34 can be detected. Rather, the functions of the specimen pad 12 and the moisture absorption pad 18 of the conventional assay strip 10 are simultaneously performed (see FIG. 1 and the background art). Since the membrane strip 30 is composed of a single membrane 32 having no pads overlapped, the amount of the sample and the like that the membrane 32 can absorb is constant, so that the membrane strip 30 is related to the amount of the injected solution. A certain amount of sample can be accommodated, and when the absorption is completed, the antigen-antibody reaction is terminated and the signal (such as the development of the test line 34) is kept constant, thereby improving the accuracy of the sample analysis.
  • the length of the membrane strip 30 it is possible to arbitrarily adjust the speed of the mobile phase (sample, etc.) and the antigen-antibody reaction time according to the type of the sample.
  • one or more, preferably two to three membrane strips 30 may be used, and the accuracy of the measurement can be improved by averaging each measurement.
  • the membrane strip 30 may further form a control line 36 on the porous membrane 32 as an internal control for accuracy of quantitative analysis according to the type of specimen.
  • the control line 36 may be formed by fixing a material that emits a constant signal regardless of the concentration of the sample, for example, anti-rabbit lgG, Anti-mouse IgG, streptavidin (streptavidin), etc. You can.
  • the size and position of the test line 34 and control line 36 may be appropriately set according to the antigen-antibody reaction used.
  • the membrane strip 30 may be formed by attaching the membrane 32 to a plastic support.
  • the use of the plastic support is preferred because the membrane 32 is durable and easy to mount on the upper and lower cases.
  • a nitrocellulose membrane, a glass fiber membrane, a polyether sulfone (PES) membrane, a cellulose membrane, a nylon membrane, a mixture thereof, or the like may be used, and preferably have pores having a size of 5 to 15 ⁇ m. Nitrocellulose membranes can be used.
  • the plastic support may be made of a polypropylene film, a polyester film, a polycarbonate film, an acrylic film, or the like.
  • a sample inlet 42 is formed at a position corresponding to the sample reservoir 52 of the lower case 50, and the inspection line 34 of the membrane strip 30 is formed. And a result confirmation window 44 at a position corresponding to the control line 36.
  • the solution is placed at a position where the membrane strip 30 is in contact with the sample reservoir 52. It is possible to further form a protrusion 46 in which the height of the protruding portion decreases in the moving direction, so that the membrane strip 30 can be bent and contacted with the sample reservoir 52 (FIG. 3 (upper case 40). Magnified bottom view of the protrusions 46 formed in the backplane).
  • a sample reservoir 52 is formed for storing a solution such as injected sample and transferring the sample to the membrane strip 30.
  • the membrane strip 30 is formed therein.
  • the guide 54 and the strip support part 56 may be formed in the lower case 50 or in both the upper case 40 and the lower case 40 as necessary.
  • the sample transfer pad 58 may be made of a material such as polyester and glass fiber, and do not overlap with the membrane strip 30 to be discontinuous.
  • the upper and lower cases 40 and 50 may be made of a conventional plastic material, for example, polycarbonate, acrylonitrile butadiene styrene (ABS), or the like.
  • the upper and lower cases 40 and 50 may be coupled by conventional means, such as coupling grooves, coupling protrusions, or may be integrally formed in some cases.
  • the sample in order to detect analytes in a sample, the sample must be mixed with the liquid buffer and the detector and then introduced into the sample reservoir 52.
  • the liquid buffer functions as a mobile phase for dissolving and moving the detector, and if necessary, may dilute a sample or hemolyze (lyse) whole blood sample components such as red blood cells.
  • a conventional buffer solution such as a 10 mM to 1 M concentration phosphate buffer, a nonionic or amphoteric surfactant, or a mixture thereof may be appropriately selected according to the antigen-antibody reaction.
  • the detector detects labels that generate signals that can be detected using the naked eye or sensors, such as latex particles, gold particles, colored polystyrene microparticles, enzymes, fluorescent dyes, conductive polymers, magnetic particles, and the like. It is conjugated to ligands, such as an antigen and an antibody which react with a specific analyte.
  • labels that generate signals that can be detected using the naked eye or sensors, such as latex particles, gold particles, colored polystyrene microparticles, enzymes, fluorescent dyes, conductive polymers, magnetic particles, and the like. It is conjugated to ligands, such as an antigen and an antibody which react with a specific analyte.
  • the immunoassay device of the present invention uses the sample pretreatment device such that a mixture of the sample and the detector is homogeneously formed by mixing the sample, the liquid buffer and the detector in a predetermined amount.
  • the sample pretreatment apparatus used in the present invention includes a protrusion 64 having a capillary tube 62 into which a sample is introduced, and a detector pad 66 having a detector fixed thereon.
  • a diaphragm 74 for mixing the liquid buffer and the sample and the detector in the chamber 72 and the other end of the chamber 72, and a nozzle 76 for discharging the pretreated sample in the chamber 72. It comprises a buffer receiving portion 70, including.
  • the protrusion 64 has a protrusion shape to penetrate the diaphragm 74, and a capillary 62 into which a predetermined amount (eg, 1 to 100 ⁇ L, preferably 10 ⁇ L) of sample is introduced according to the diameter and length. This is formed.
  • the detector pad 66 is a disc in which the detector is deposited in a solid phase on a pad made of glass fiber, polyester, wood pulp paper, a mixture thereof, or the like.
  • the chamber 72 is a cylindrical space in which the liquid buffer is accommodated, and the liquid buffer, the sample and the detector can be mixed.
  • the chamber 72 is pressurized to apply the pretreated sample (sample, liquid buffer and detector mixture) to the nozzle. It may have elasticity to discharge through 76.
  • the diaphragm 74 may seal the chamber 72 to prevent leakage of the liquid buffer, evaporation, and the like, and may be made of a material that is torn and opened by the protrusion 64. For example, it may be made of aluminum foil, plastic, rubber, or the like.
  • the nozzle 76 is a hole for discharging the pretreated sample, and may be a small hole of a long shape.
  • the sample pretreatment device as the projection 64 of the sample and detector receiving unit 60 is located in the chamber 72 through the diaphragm 74 of the buffer receiving unit 70 is coupled to each other.
  • the capillary tube 62 and the detector pad 66 are positioned inside the chamber 72 so that the capillary tube 62 and the detector pad 66 are mixed with the liquid phase buffer of the chamber 72.
  • the mixing of the liquid buffer, the sample and the detector can be more reliably mixed by shaking the sample pretreatment device, for example, the sample pretreatment device can be mixed by shaking up and down about 10 times.
  • the nozzle stopper 78 may further include.
  • the nozzle cap 78 may have a conventional bottle cap shape and a material, and may include a protrusion blocking the hole of the nozzle 76.
  • the sample and detector receiver 60 and the buffer receiver 70 may be made of plastic, rubber, or the like, and may be coated with a hydrophobic or hydrophilic material on its surface.
  • the detector pad 66 is inserted into the sample and the detector accommodating part 60 of the sample pretreatment apparatus, and the sample is capillary 62 of the sample and the detector accommodating part 60. Sucking; Inserting the specimen and detector receiver (60) into the buffer receiver (70), and mixing the specimen, the detector and the liquid buffer to form a pretreated specimen; It comprises a porous membrane 32 is formed with a test line (34) fixed to the capture agent for binding the sample pre-treated in the buffer receiving portion 70 in the sample with an analyte and / or detector in an antigen-antibody reaction. Injecting and moving into the membrane strip 30; And detecting an analyte of the pretreated sample passing through the test line 34 of the membrane strip 30 by an antigen-antibody reaction.
  • the pretreated sample moves through the porous membrane 32 and reacts with the capture agent fixed to the inspection line 34 of the porous membrane 32 so that the physical properties such as color of the inspection line 34 may be improved.
  • changes in physical properties can be detected and analyzed using the naked eye or a sensor to perform an immunoassay.
  • the immunoassay method is a sandwich assay
  • the analyte in the sample and the ligand site of the detector form an immunocomplex by an immunological reaction.
  • the immunocomplex moves through the porous membrane 32 along the flow of the sample and is captured by an immunologically specific binding reaction at the test line 34, which is the site where the trap is immobilized.
  • the porous membrane 32 is formed with a test line 34 made of traps that react with the ligand site of the detector, which captures the analyte and the analyte. It may be the same material or an analog thereof.
  • the intensity of the signal generated by the detector's label is proportional or inversely proportional to the amount of analyte, so that the presence or absence of the analyte can be qualitatively detected, such as positive or negative, and further, the signal intensity is standardized.
  • the amount of analyte can be quantitatively determined in comparison to the colorimetric table.
  • Whole blood that can be used as the sample includes not only raw blood obtained directly from the human body or animal, but also all blood components including one or more components having low passage rate in the detector pad such as red blood cells, plasma, and serum. do.
  • Human red blood cells contain proteins for oxygen transport called hemoglobin. When blood sugar (glucose) rises in the blood, some of the glucose in the blood is bound to hemoglobin. The hemoglobin combined with glucose is called glycated hemoglobin and is also called hemoglobin A1c (HbA1c).
  • the normal life of red blood cells is about 120 days, and some of the red blood cells in our bodies are destroyed every day, and the amount of red blood cells similar to this destroyed amount is generated and maintained at a constant level. However, once glycated hemoglobin is created by combining with glucose, the red blood cells have a glycated hemoglobin until their life span is broken down.
  • Glucose testing is a test that checks how much sugar is in your blood every day, while glycated hemoglobin tests reflect an average of 8 weeks of blood sugar.
  • fasting blood glucose level should be fasted for at least 8 hours, and blood sugar level should be checked by blood collection 2 hours after eating, but glycated hemoglobin test should be done regardless of meal time. It has the advantage to do it.
  • the glycated hemoglobin test reflects a relatively long-term blood glucose level, it is used as an indicator to know whether diabetes is well managed by treatment in recent months.
  • the treatment goal of diabetes is to maintain normal blood sugar in order to prevent complications, and frequent blood glucose measurement is necessary to determine whether diabetes management is performed well.
  • measuring blood glucose frequently is cumbersome, so when blood glucose cannot be measured frequently, or when there is no need to measure it frequently, the glycated hemoglobin test can be used to determine the average blood sugar level over a long period of time. It is easy to see if this is going well.
  • a high glycated hemoglobin level may be considered a poor treatment for diabetes, and patients will be treated for diabetes, such as applying a more stringent diet or increasing insulin infusion.
  • the conventional glycated hemoglobin measurement was most often measured in the clinical laboratory of the hospital, there was a disadvantage that the bulky equipment, expensive reagents and consumables.
  • the immunoassay device can measure the glycated hemoglobin concentration from the color of the detector label on the inspection line 34 (using a spectroscopy or the like as a sensor), the background color of the porous membrane 32, That is, the concentration of the whole hemoglobin (hemoglobin) can be measured by measuring the red color peculiar to the hemoglobin transferred to the capillary phenomenon through an image sensor.
  • two membrane strips 30, that is, the membrane strip 30 for measuring the total hemoglobin concentration and the membrane strip 30 for measuring the glycated hemoglobin concentration may be used.
  • Three membrane strips 30, that is, the membrane strip 30 for measuring the total hemoglobin concentration and the membrane strip 30 for measuring the glycated hemoglobin concentration, can be used to improve the accuracy of the analysis. From the concentrations of total hemoglobin and glycated hemoglobin, the concentration percentage (rate) of glycated hemoglobin relative to total hemoglobin can be obtained, and a long-term blood glucose level and diabetes status and progress status can be easily determined by a simple method (glycosylated hemoglobin relative to total hemoglobin). When the concentration percentage of is 3 to 6%, it is normal, and when it is 6 to 20%, it indicates diabetes.
  • the immunoassay device can test for influenza (type A and type B) antigens.
  • influenza type A and type B antigens.
  • influenza viruses There are three types of influenza viruses, type A, B, and C, but there are two types that affect humans.
  • influenza virus penetrates the body through the respiratory tract and infects the human body, symptoms such as sudden high fever, headache, muscle pain, and general weakness occur. If the symptoms are not treated early, pneumonia, heart muscle inflammation, and encephalitis Complications such as back may occur and lead to death.
  • influenza antigen test using the immunoassay device of the present invention
  • the sample is taken from the runny nose and throat of the patient, and the presence or absence of the influenza antigen from the sample, to determine whether the patient is infected with influenza virus It is also possible to confirm whether the type of influenza virus is type A or type B.
  • a sandwich assay method can be used, and a single porous membrane 32 can be measured. In order to improve accuracy, two membranes 32 may be used. Can be.
  • an antibody against influenza is immobilized on the test line 34 as a trap, and the antibodies against influenza A and B are immobilized in one porous membrane 4 to simultaneously diagnose the influenza A and B types. It is possible.
  • a label generating a signal (signaling substance) and an antibody ligand for influenza are used as a detector. If the influenza type A and B are measured simultaneously, the antibody for influenza type A and B is signaled, respectively. Two detectors bound to the material can be used. As a result of the sandwich assay, the capturer-antigen-detector accumulates in proportion to the antigen concentration, and the label coloration from this capturer-antigen-detector and the concentration of the influenza antigen of that type from the corresponding test line 34 in which it appeared. Can be measured (by using a spectrometer or the like as the naked eye or a sensor).
  • influenza antigen test is mainly a qualitative test rather than a quantitative test, so it is possible to test with only one porous membrane 32 and a case having a structure capable of accommodating one porous membrane 32. (Upper case 80, Lower case 81, see FIG. 5) can also be produced and used.
  • the immunoassay device is capable of testing malaria antigens (tropical fever, triplet fever, silt fever, ovary) using blood as a sample.
  • Malaria is one of the most common and serious tropical diseases. When a mosquito bites, it is infected by a protozoan from the mosquito.
  • Human malaria is classified into tropical fever, trigeminal fever, silt fever malaria and ovarian malaria according to clinical symptoms and characteristics of pathogens. Fever, chills, headache, myalgia, anemia and spleen are common symptoms. More than 10,000 malaria cases occur each year, of which about 1% are dying because of early diagnosis and poor treatment, and early diagnosis through malaria antigen test is very important.
  • the blood of the patient is taken as a sample, and the presence or absence of malaria antigen (protozoa) from the sample, to determine whether the patient is infected with malaria have.
  • malaria antigen protozoa
  • a sandwich assay method can be used, and a single porous membrane 32 can be measured. In order to improve accuracy, two membranes 32 can be used. have.
  • an antibody against malaria is immobilized on the inspection line 34 as a capturer, and a combination of a label (signal generator) that generates a signal and an antibody against malaria is used as a detector.
  • the trapper-antigen-detector accumulates in proportion to the antigen concentration, and the label development from the trapper-antigen-detector and the concentration of the malaria antigen from the corresponding test line 34 in which it appears ( The naked eye or a spectroscope etc. can be used as a sensor).
  • the malaria antigen test is mainly a qualitative test rather than a quantitative test, so that only one porous membrane 32 can be used for the test, and the case has a structure that can accommodate one porous membrane 32. (Upper case 80, Lower case 81, see FIG. 5) can also be produced and used.
  • the immunoassay device using serum or plasma as a sample, it is possible to test for three major diseases (pandemic hemorrhagic fever, Tsutsugamu, Leptospira) that can occur frequently in autumn.
  • the three diseases are different from the causative bacteria, but they develop actively in the fall, and have commonalities in the disease propagation process and symptoms. In other words, it occurs frequently in late autumn through outdoor activities such as beesweed and picnic, and has a common point of high fever and various complications.
  • the three major recessive diseases are infected, antibodies to the causative bacteria and viruses of the three recessive diseases are generated in the body, and the antibody can be diagnosed by diagnosing the infection.
  • the serum or plasma of the patient is collected as a sample, and the presence or absence of antibodies to the three recessive diseases from the sample is detected. You can check whether you are infected with a recessive disease.
  • a sandwich assay method may be used, and one porous membrane 32 may be used to measure the two membranes 32 to improve accuracy. This can be used.
  • an antigenic substance capable of capturing the antibody is immobilized.
  • the antigenic substance may be immobilized with an inactivated virus or cell itself, and may be immobilized with a substance capable of recognizing and capturing a corresponding antibody in the body, such as a recombinant protein or antigenic peptide.
  • Detectors include signals that generate signals (signals) and inactivated viruses, organisms, recombinant proteins, antigenic peptides, etc. that have antigenicity, such as anti-human IgG or anti-human IgM, Protein A, Protein G, etc. A combination of these is used.
  • the capturer-antibody-detector accumulates in proportion to the antigen concentration, and the label development from this capturer-antibody-detector and the antibody against the three major recessive diseases from the corresponding test line 34 in which it appeared. Can be measured (by using a spectroscopy or the like as the naked eye or a sensor).
  • the three major recessive diseases in autumn unlike the previously mentioned glycated hemoglobin, are mainly tested for qualitative rather than quantitative tests, so only one porous membrane 32 can be tested and can accommodate one porous membrane 32.
  • a case having a structure (upper case 80, lower case 81, see FIG. 5) may be manufactured and used.
  • the immunoassay device of the present invention includes influenza (types A and B), malaria antigens (tropical fever, triplet fever, silt fever, ovary), three major febrile diseases (genotypic hemorrhagic fever, Tsutsugamushi, leptospira), HIV, hepatitis C Hepatitis B, syphilis, gastric ulcer bacteria, cancer markers (AFP, PSA, CEA), tuberculosis, SARS, dengue, leprosy and other diseases using serum, whole blood, runny nose, feces, etc. It is also very useful for testing.
  • influenza types A and B
  • malaria antigens tropical fever, triplet fever, silt fever, ovary
  • three major febrile diseases genotypic hemorrhagic fever, Tsutsugamushi, leptospira
  • HIV hepatitis C Hepatitis B
  • syphilis gastric ulcer bacteria
  • cancer markers AFP
  • the immunoassay device is useful for an analytical device using an immunochromatographic assay such as influenza, malaria, three major febrile diseases (patent hemorrhagic fever, Tsutsugamu, leptospira), and glycated hemoglobin.
  • immunochromatographic assay such as influenza, malaria, three major febrile diseases (patent hemorrhagic fever, Tsutsugamu, leptospira), and glycated hemoglobin.

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Abstract

L'invention concerne un dispositif de dosage immunologique qui utilise une bande à membrane unique et qui est capable d'améliorer l'exactitude de l'analyse d'échantillons en maintenant une quantité d'absorption d'échantillon et une durée réactionnelle antigène-anticorps constantes, et un procédé de dosage immunologique utilisant le dispositif de dosage immunologique. Le dispositif de dosage immunologique comprend : au moins une bande membranaire incluant une membrane poreuse ayant une ligne de dosage à laquelle un capteur, se liant à un analyte dans un échantillon et/ou à un détecteur par l'intermédiaire d'une réaction antigène-anticorps, est fixé ; un boîtier supérieur recouvrant la partie supérieure de la bande membranaire et ayant une entrée d'échantillon et une fenêtre d'observation de résultat ; un boîtier inférieur recouvrant une partie inférieure de la bande membranaire et disposant d'une zone de stockage d'échantillon ; et une unité de prétraitement d'échantillon pour le mélange de l'échantillon, un tampon liquide et un détecteur pour entrer le mélange résultant au niveau de la zone de stockage d'échantillon.
PCT/KR2010/000972 2010-02-17 2010-02-17 Dispositif de dosage immunologique et procédé de dosage immunologique l'utilisant WO2011102563A1 (fr)

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CN108427006A (zh) * 2018-05-16 2018-08-21 吉林吉和迅生物技术有限公司 一种胶体金快速检测试纸卡
CN110018301A (zh) * 2018-01-09 2019-07-16 上海八通生物科技股份有限公司 一种组合式免疫层析装置
WO2021205228A1 (fr) 2020-04-07 2021-10-14 Abbott Rapid Diagnostics International Unlimited Company Dispositif de dosage
WO2022029494A1 (fr) 2020-08-04 2022-02-10 Abbott Rapid Diagnostics International Unlimited Company Analyses pour la détection de sars-cov-2
CN115078348A (zh) * 2022-06-13 2022-09-20 江苏倍锋医疗科技有限公司 一种湿度控制的精准快速检测装置及其检测方法
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CN110018301A (zh) * 2018-01-09 2019-07-16 上海八通生物科技股份有限公司 一种组合式免疫层析装置
CN108427006A (zh) * 2018-05-16 2018-08-21 吉林吉和迅生物技术有限公司 一种胶体金快速检测试纸卡
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EP4071475A1 (fr) 2021-04-08 2022-10-12 Abbott Rapid Diagnostics International Unlimited Company Dispositif d'analyse
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CN115078348A (zh) * 2022-06-13 2022-09-20 江苏倍锋医疗科技有限公司 一种湿度控制的精准快速检测装置及其检测方法
CN115078348B (zh) * 2022-06-13 2023-07-21 江苏倍锋医疗科技有限公司 一种精准快速检测装置及其检测方法

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