CN112014579A - Hemoglobin immunochromatography detection test strip - Google Patents
Hemoglobin immunochromatography detection test strip Download PDFInfo
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- CN112014579A CN112014579A CN202010778890.4A CN202010778890A CN112014579A CN 112014579 A CN112014579 A CN 112014579A CN 202010778890 A CN202010778890 A CN 202010778890A CN 112014579 A CN112014579 A CN 112014579A
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- 102000001554 Hemoglobins Human genes 0.000 title claims abstract description 33
- 108010054147 Hemoglobins Proteins 0.000 title claims abstract description 33
- 238000012360 testing method Methods 0.000 title claims abstract description 25
- 238000003317 immunochromatography Methods 0.000 title claims abstract description 18
- 238000001514 detection method Methods 0.000 title claims abstract description 13
- 238000006243 chemical reaction Methods 0.000 claims abstract description 38
- 102000017011 Glycated Hemoglobin A Human genes 0.000 claims abstract description 33
- 238000004587 chromatography analysis Methods 0.000 claims abstract description 32
- 108010014663 Glycated Hemoglobin A Proteins 0.000 claims abstract description 19
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000010521 absorption reaction Methods 0.000 claims abstract description 4
- 238000011534 incubation Methods 0.000 claims description 25
- 239000012528 membrane Substances 0.000 claims description 20
- 108091005995 glycated hemoglobin Proteins 0.000 claims description 14
- 238000003908 quality control method Methods 0.000 claims description 14
- 239000004745 nonwoven fabric Substances 0.000 claims description 6
- 238000013096 assay test Methods 0.000 claims description 4
- 241000283707 Capra Species 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000003365 glass fiber Substances 0.000 claims description 3
- 230000002035 prolonged effect Effects 0.000 abstract description 3
- 230000035484 reaction time Effects 0.000 abstract description 3
- 230000035945 sensitivity Effects 0.000 abstract description 3
- 210000004369 blood Anatomy 0.000 description 10
- 239000008280 blood Substances 0.000 description 10
- 206010012601 diabetes mellitus Diseases 0.000 description 7
- 235000000346 sugar Nutrition 0.000 description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- 230000007547 defect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 238000011269 treatment regimen Methods 0.000 description 2
- 206010007749 Cataract diabetic Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 208000007342 Diabetic Nephropathies Diseases 0.000 description 1
- 206010063547 Diabetic macroangiopathy Diseases 0.000 description 1
- 206010055690 Foetal death Diseases 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 201000007025 diabetic cataract Diseases 0.000 description 1
- 208000033679 diabetic kidney disease Diseases 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 210000003754 fetus Anatomy 0.000 description 1
- 208000004104 gestational diabetes Diseases 0.000 description 1
- 230000036252 glycation Effects 0.000 description 1
- 230000002641 glycemic effect Effects 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 201000011461 pre-eclampsia Diseases 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
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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
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
-
- 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
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
-
- 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
- G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
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- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention belongs to the field of immunodetection, and particularly relates to a hemoglobin immunochromatography detection test strip which comprises a chromatography module, a sample adding cup and a temperature and flow rate control accessory, wherein the chromatography module is movably arranged on the surface of the temperature and flow rate control accessory, the sample adding cup is nested at the front end of the temperature and flow rate control accessory, and the chromatography module comprises an inclined-side sample reaction zone, an immunochromatography reaction zone and a water absorption pad; according to the invention, the inclined side sample reaction area is arranged, so that the antigen-antibody reaction time is prolonged, and the chromatography speed is reduced, thereby improving the sensitivity and precision; in addition, the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and the hemoglobin monoclonal antibody marked by the colloidal gold are arranged at the bottom of the sample cup, so that the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and the hemoglobin monoclonal antibody marked by the colloidal gold are more stable than the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and sprayed on the gasket, and the anti-interference capability can be improved; and temperature and velocity of flow control accessory then can realize the control of sample temperature and chromatography reaction temperature, reduce the interference of ambient temperature, improve the degree of accuracy of testing result.
Description
Technical Field
The invention belongs to the field of immunodetection, and particularly relates to a hemoglobin immunochromatographic assay test strip.
Background
Glycated hemoglobin (GHb) is a product of hemoglobin in red blood cells combined with sugars in serum. It is formed by slow, continuous and irreversible glycation reactions, the content of which depends on the blood glucose concentration and the contact time of blood glucose and hemoglobin, and is independent of factors such as the blood drawing time, whether the patient is fasting, whether insulin is used, and the like. Therefore, GHb can effectively reflect the condition of blood sugar control of the diabetic in the past 1-2 months. GHb consists of HbA1a, HbA1b, and HbA1c, wherein HbA1c accounts for about 70%, and is structurally stable, and thus is used as a monitoring index for diabetes control. Glycated hemoglobin is a gold standard for measuring glycemic control and is also an important means for diagnosing and managing diabetes. In the treatment of diabetes, the glycated hemoglobin level has important clinical significance for evaluating the overall control of blood glucose, finding problems in treatment, and guiding treatment regimens.
The glycosylated hemoglobin is an index of the total blood sugar control condition of a diabetic, if the glycosylated hemoglobin is more than 9 percent, the diabetic patients continuously have hyperglycemia, complications such as diabetic nephropathy, arteriosclerosis, cataract and the like can occur, and the glycosylated hemoglobin is also a high-risk factor of myocardial infarction and cerebral apoplexy death. The measurement of glycated hemoglobin can be used to guide the adjustment of the treatment regimen. The glycosylated hemoglobin has certain significance for judging different stages of diabetes. Blood sugar is increased under stress conditions such as cerebrovascular emergency, but glycosylated hemoglobin is not increased. The gestational diabetes is not enough to measure the blood sugar, and the control of the glycosylated hemoglobin is more significant, so that huge fetuses, dead fetuses, teratocarcinoses and preeclampsia can be avoided.
At present, aiming at the defects of long time consumption, low precision and poor environment temperature interference resistance of product detection of glycosylated hemoglobin detection, the application requirements of multiple scenes cannot be completely met.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the hemoglobin immunochromatographic test strip which is high in detection speed, high in precision and strong in anti-interference capability.
In order to achieve the purpose, the invention adopts the following technical scheme:
a hemoglobin immunochromatography detection test strip comprises a chromatography module (1), a sample adding cup and a temperature and flow rate control accessory, wherein the chromatography module is movably placed on the surface of the temperature and flow rate control accessory, the sample adding cup is nested at the front end of the temperature and flow rate control accessory, and the chromatography module comprises an inclined-side sample reaction zone, an immunochromatography reaction zone and a water absorption pad;
wherein the inclined side sample reaction area is rotationally connected with an immunochromatography reaction area, and the immunochromatography reaction area comprises a first chromatographic membrane and a second chromatographic membrane which are parallel;
wherein the interval between the first chromatographic membrane and the second chromatographic membrane is 1-3mm, a hemoglobin test line and a first quality control line are fixed on the first chromatographic membrane (5), and a glycosylated hemoglobin test line and a second quality control line are fixed on the second chromatographic membrane.
The hemoglobin test line is fixed with a hemoglobin monoclonal antibody, the glycosylated hemoglobin test line is fixed with a glycosylated hemoglobin monoclonal antibody, and the first quality control line and the second quality control line are fixed with goat anti-mouse IgG polyclonal antibodies.
Preferably, the inclined side sample reaction zone comprises a filtering glass fiber layer and a non-woven fabric layer, and the inclined side sample reaction zone is connected with the immunochromatography reaction zone through the non-woven fabric layer.
Preferably, the section of the sample adding cup is in a right trapezoid shape, and the bottom of the sample adding cup is provided with a colloidal gold-labeled glycated hemoglobin monoclonal antibody and a colloidal gold-labeled hemoglobin monoclonal antibody.
Preferably, the temperature and flow rate control assembly comprises a sample tank, a sample incubation zone, an inclined side flow rate control zone, a chromatography incubation zone, and a temperature control unit.
Preferably, the sample cup can be nested in the sample groove, and the sample incubation area is arranged at the bottom of the sample groove.
Preferably, the temperature control unit is electrically connected with a sample incubation area and a chromatography incubation area, wherein the temperature of the sample incubation area is 37 +/-0.5 ℃, and the temperature of the chromatography incubation area is 28 +/-0.5 ℃.
Compared with the prior art, the invention has the beneficial effects that:
according to the invention, the inclined side sample reaction area is arranged, so that the antigen-antibody reaction time is prolonged, and the chromatography speed is reduced, thereby improving the sensitivity and precision; in addition, the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and the hemoglobin monoclonal antibody marked by the colloidal gold are arranged at the bottom of the sample cup, so that the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and the hemoglobin monoclonal antibody marked by the colloidal gold are more stable than the glycosylated hemoglobin monoclonal antibody marked by the colloidal gold and sprayed on the gasket, and the anti-interference capability can be improved; and temperature and velocity of flow control accessory then can realize the control of sample temperature and chromatography reaction temperature, reduce the interference of ambient temperature, improve the degree of accuracy of testing result.
Drawings
FIG. 1 is a top view of a chromatography module of the present invention;
FIG. 2 is a side view block diagram of the chromatography module of the present invention;
FIG. 3 is a side view block diagram of the temperature and flow rate control assembly of the present invention;
description of reference numerals: 1. a chromatography module; 2. an oblique side sample reaction zone; 3. an immunochromatographic reaction zone; 4. a water absorbent pad; 5. a first chromatographic membrane; 6. a second chromatographic membrane; 7. a hemoglobin test line; 8. a first quality control line; 9. a glycated hemoglobin test line; 10. a second quality control line; 11. temperature and flow rate control fittings; 12. a sample tank; 13. a sample incubation zone; 14. an oblique flow rate control zone; 15. a chromatographic incubation zone.
Detailed Description
The embodiments of the invention will be described in detail below with reference to the drawings, but the invention can be implemented in many different ways as defined and covered by the claims.
Example 1
A hemoglobin immunochromatography detection test strip comprises a chromatography module 1, a sample adding cup and a temperature and flow rate control accessory 11, wherein the chromatography module 1 is movably placed on the surface of the temperature and flow rate control accessory (11), the sample adding cup is nested at the front end of the temperature and flow rate control accessory (11), and the chromatography module 1 comprises an inclined-side sample reaction zone 2, an immunochromatography reaction zone 3 and a water absorption pad 4;
wherein the inclined side sample reaction zone 2 is rotationally connected with an immunochromatography reaction zone 3, and the immunochromatography reaction zone 3 comprises a first chromatographic membrane 5 and a second chromatographic membrane 6 which are parallel;
wherein the interval between the first chromatographic membrane 5 and the second chromatographic membrane 6 is 1-3mm, a hemoglobin test line 7 and a first quality control line 8 are fixed on the first chromatographic membrane 5, and a glycosylated hemoglobin test line 9 and a second quality control line 10 are fixed on the second chromatographic membrane 6.
Wherein, a hemoglobin monoclonal antibody is fixed on the hemoglobin test line 7, a glycated hemoglobin monoclonal antibody is fixed on the glycated hemoglobin test line 9, and goat anti-mouse IgG polyclonal antibodies are fixed on the first quality control line 8 and the second quality control line 10.
Further, the inclined-side sample reaction zone 2 comprises a filtering glass fiber layer and a non-woven fabric layer, and the inclined-side sample reaction zone 2 is connected with the immunochromatography reaction zone 3 through the non-woven fabric layer.
Further, the section of the sample adding cup is in a right trapezoid shape, and the bottom of the sample adding cup is provided with a colloidal gold-labeled glycosylated hemoglobin monoclonal antibody and a colloidal gold-labeled hemoglobin monoclonal antibody.
Further, the temperature and flow rate control assembly 11 includes a sample tank 12, a sample incubation region 13, an oblique flow rate control region 14, a chromatography incubation region 15, and a temperature control unit.
Further, the sample cup can be nested in the sample tank 12, and the sample incubation area 13 is disposed at the bottom of the sample tank 12.
Further, the temperature control unit is electrically connected with the sample incubation area 13 and the chromatography incubation area 15, the temperature of the sample incubation area 13 is 37 +/-0.5 ℃, and the temperature of the chromatography incubation area 15 is 28 +/-0.5 ℃.
When detecting a sample, firstly electrifying the temperature and flow rate control accessory (11), enabling the temperature of the sample incubation area 13 to be 37 +/-0.5 ℃, enabling the temperature of the chromatography incubation area 15 to be 28 +/-0.5 ℃, then placing a sample adding sample in the sample groove 12 of the chromatography module, placing the chromatography module 1 on the temperature and flow rate control accessory (11), inserting the sample reaction area at the inclined side into a reaction cup, adding a blood sample into the reaction cup, timing for 5min, and then carrying out quantitative detection by adopting a matched colloidal gold card reader, thereby calculating the ratio of hemoglobin in blood.
The method has the advantages that the operation is simple, the detection speed is high, the antigen-antibody reaction time is prolonged and the chromatography speed is reduced by arranging the inclined sample reaction area, so that the sensitivity and the precision are improved; the control of the sample temperature and the chromatographic reaction temperature can reduce the interference of the environmental temperature and improve the accuracy of the detection result.
The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and variations that can be made by the present invention in the specification or directly or indirectly applied to other related technical fields are included in the scope of the present invention.
Claims (6)
1. The hemoglobin immunochromatography detection test strip is characterized by comprising a chromatography module (1), a sample adding cup and a temperature and flow rate control accessory (11), wherein the chromatography module (1) is movably placed on the surface of the temperature and flow rate control accessory (11), the sample adding cup is nested at the front end of the temperature and flow rate control accessory (11), and the chromatography module (1) comprises an inclined-side sample reaction zone (2), an immunochromatography reaction zone (3) and a water absorption pad (4);
wherein the inclined side sample reaction zone (2) is rotationally connected with an immunochromatography reaction zone (3), and the immunochromatography reaction zone (3) comprises a first chromatographic membrane (5) and a second chromatographic membrane (6) which are parallel;
wherein the interval between the first chromatographic membrane (5) and the second chromatographic membrane (6) is 1-3mm, a hemoglobin test line (7) and a first quality control line (8) are fixed on the first chromatographic membrane (5), and a glycosylated hemoglobin test line (9) and a second quality control line (10) are fixed on the second chromatographic membrane (6).
Wherein, a hemoglobin monoclonal antibody is fixed on the hemoglobin test line (7), a glycated hemoglobin monoclonal antibody is fixed on the glycated hemoglobin test line (9), and goat anti-mouse IgG polyclonal antibodies are fixed on the first quality control line (8) and the second quality control line (10).
2. The hemoglobin immunochromatographic assay test strip of claim 1, wherein the inclined side sample reaction zone (2) comprises a filtration glass fiber layer and a nonwoven fabric layer, and the inclined side sample reaction zone (2) is connected to the immunochromatographic reaction zone (3) through the nonwoven fabric layer.
3. The hemoglobin immunochromatographic assay test strip of claim 1, wherein the cross section of the sample cup is a right trapezoid, and the bottom of the sample cup is provided with a colloidal gold labeled glycated hemoglobin monoclonal antibody and a colloidal gold labeled hemoglobin monoclonal antibody.
4. The hemoglobin immunochromatographic test strip of claim 1, wherein the temperature and flow rate control member (11) comprises a sample tank (12), a sample incubation zone (13), a diagonal flow rate control zone (14), a chromatography incubation zone (15), and a temperature control unit.
5. The test strip for immunochromatographic detection of hemoglobin according to claim 1 or 3, wherein the sample cup is nestably placed in the sample well (12), and the sample incubation zone (13) is disposed at the bottom of the sample well (12).
6. The hemoglobin immunochromatographic assay test strip of claim 1 or 3, wherein the temperature control unit is electrically connected to a sample incubation zone (13) and a chromatography incubation zone (15), the temperature of the sample incubation zone (13) is 37 ± 0.5 ℃, and the temperature of the chromatography incubation zone (15) is 28 ± 0.5 ℃.
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| CN202010778890.4A CN112014579A (en) | 2020-08-05 | 2020-08-05 | Hemoglobin immunochromatography detection test strip |
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| CN202010778890.4A CN112014579A (en) | 2020-08-05 | 2020-08-05 | Hemoglobin immunochromatography detection test strip |
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