Immunochromatographic test strip for detecting content of glycated hemoglobin as well as immunoassay detection apparatus comprising same

An immunochromatographic test strip, glycosylated hemoglobin technology, applied in the field of immunodetection, can solve the problems of affecting results, complicated calculation, increased cost, etc., to achieve the effects of simplifying production, simplifying calculation steps, and reducing costs

Pending Publication Date: 2019-03-12
北京康思润业生物技术有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The above-mentioned immunochromatography test strip technology generally uses two pairs of antibodies, one pair of glycosylated hemoglobin antibody and one pair of hemoglobin antibody, which are respectively labeled and coated, which has the following disadvantages: 1. There are many components, which may interfere with each other and affect the results; 2. .Using two pairs of antibodies greatly increases the cost; 3. Calculate the concentration of the two pairs of antibodies first, and then determine the ratio, which makes the calculation complicated

Method used

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  • Immunochromatographic test strip for detecting content of glycated hemoglobin as well as immunoassay detection apparatus comprising same
  • Immunochromatographic test strip for detecting content of glycated hemoglobin as well as immunoassay detection apparatus comprising same
  • Immunochromatographic test strip for detecting content of glycated hemoglobin as well as immunoassay detection apparatus comprising same

Examples

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preparation example Construction

[0073] The preparation method of the above-mentioned immunochromatographic test strip for detecting the content of glycosylated hemoglobin comprises the following steps:

[0074] 1) On the nitrocellulose membrane 3, the marking line 33, the detection line 31 and the quality control line 32 are coated, and the two sides of the nitrocellulose membrane 3 are respectively bonded with the glass cellulose membrane 2 and the absorbent paper 4 and fixed on the Bottom plate 1, obtain test strip blank;

[0075] 2) cutting the test strip blank obtained in step 1) into a required size to obtain the immunochromatographic test strip;

[0076] or include the following steps:

[0077] 1) Coating the detection line 31 and the quality control line 32 on the nitrocellulose membrane 3, bonding the two sides of the nitrocellulose membrane 3 to the marker pad 5, the absorbent paper 4 and the glass cellulose membrane 2 respectively and fixing them On base plate 1, obtain test strip blank;

[0078] ...

Embodiment 1

[0109] This embodiment provides a method for manufacturing an immunochromatographic detection device, comprising the following steps:

[0110] Coating antibody: Dilute glycosylated hemoglobin (HbA1c) detection antibody 1 and quality control antibody 1 (goat anti-mouse) to a fixed concentration (2.0 mg / ml) with coating buffer, and use special coating equipment to mix the above two liquids Coated onto Sartorius nitrocellulose membrane (NC), dried in a 37°C oven for 4 hours, and set aside. The coating buffer is 0.01M phosphate buffer solution (PBs) plus 3wt% sucrose as a protective agent.

[0111]Labeled antibody: human hemoglobin (Hb) detection antibody 2 is labeled with latex fluorescence (the mass ratio of latex microspheres to both antibodies is 1:10), and stored in storage solution (50mM Tris, 0.5% BSA, pH 7.8) ,spare.

[0112] Sample pad preparation: Soak or spray the sample treatment solution into the sample pad according to the required concentration, and dry it for lat...

Embodiment 2

[0119] The structure of the test strip in this embodiment is the same as that in Example 1, the difference is that in this embodiment, the fluorescent marker is not sprayed on the sample pad, but the fluorescent marker is placed in the fluorescent gun head .

[0120] Coating antibody: same as Example 1.

[0121] Labeled antibody: same as Example 1.

[0122] Sample pad preparation: same as Example 1.

[0123] Preparation of fluorescent pipette tip: Dilute the human hemoglobin (Hb) antibody 2 marker 1 to 5 times with fluorescent spotting solution, and use Tecan EVO100-4 to spot the fluorescent spotting solution on the pipette tip (to make the final volume per person) Containing human hemoglobin (Hb) marker 10 μ g), vacuum drying for subsequent use; the specific formula of the fluorescent spotting solution is: 50mmol / L Tris-HCL, 1wt% mannitol, 5wt% trehalose, 0.9% PVA, 1wt% glycerol .

[0124] Abbreviations: Tris-HCl: tris-hydrochloride buffer, PVA: polyvinyl alcohol.

[012...

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Abstract

The invention relates to an immunochromatographic test strip for detecting content of glycated hemoglobin. The immunochromatographic test strip comprises a sample mat, a detection membrane, a water absorption mat and a marking carrier, wherein the detection membrane is connected to the sample mat, and the detection membrane is successively provided with a detection line and a quality control line;the water absorption mat is connected to the detection membrane; and the marking carrier is arranged on the detection membrane or connected with the detection membrane. The invention also provides animmunoassay detection apparatus of the immunochromatogrpahic test strip for detecting the content of the glycated hemoglobin. By adopting the immunochromatographic test strip and the immunoassay detection apparatus, the content of the glycated hemoglobin can be quantitatively detected within 3 to 15 minutes with just trace amount of whole blood sample, so that the screening speed can be greatly improved, and the advantages of high sensitivity, good specificity and simple structure can be achieved. Only one glycated hemoglobin antibody and a hemoglobin antibody are used, so that the cost is reduced, and the production is simplified.

Description

technical field [0001] The invention relates to an immunochromatographic test strip for detecting the content of glycosylated hemoglobin and an immunoanalysis detection device comprising the same, belonging to the technical field of immunodetection. Background technique [0002] The incidence of diabetes is on the rise, and it is a worldwide public health problem that seriously threatens human health. Traditional diabetes diagnosis and treatment monitoring uses fasting blood glucose, postprandial blood glucose, and oral glucose tolerance test, etc., but blood glucose parameters only represent the instantaneous blood glucose level when blood is drawn, while glycosylated hemoglubin (GHb) is used as the gold standard to reflect long-term blood glucose levels , is also an important indicator for monitoring diabetes treatment. [0003] GHb refers to hemoglobin (haemoglobin, Hb) combined with any form of carbohydrate. Human Hb is mainly HbA (95%-97%), HbA2 (<3%), HbF (<1%)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/72G01N33/558
CPCG01N33/558G01N33/723G01N33/726
Inventor 张军
Owner 北京康思润业生物技术有限公司
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