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Device for detecting HIT (Heparin-Induced Thrombocytopenia) antibodies and combined by immunological agglutination and colloidal-gold chromatographic test strip

A technology of test strips and colloidal gold pads, which is applied in the field of medical testing and can solve problems such as lack of testing methods

Inactive Publication Date: 2018-02-23
BEIJING SHUNLEI BIOTECHNOLOGY CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

All of the above-mentioned existing HIT antibody detection technologies and methods have many defects, and there is still a lack of a practical, simple and fast detection method

Method used

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  • Device for detecting HIT (Heparin-Induced Thrombocytopenia) antibodies and combined by immunological agglutination and colloidal-gold chromatographic test strip
  • Device for detecting HIT (Heparin-Induced Thrombocytopenia) antibodies and combined by immunological agglutination and colloidal-gold chromatographic test strip
  • Device for detecting HIT (Heparin-Induced Thrombocytopenia) antibodies and combined by immunological agglutination and colloidal-gold chromatographic test strip

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Embodiment 1, the preparation of assembly

[0138] 1. Preparation of gold-labeled antibody

[0139] 1. Dissolve tetrachloroauric acid in water so that the concentration of tetrachloroauric acid is 0.01g / 100mL, which is tetrachloroauric acid solution.

[0140] 2. Dissolve trisodium citrate in water so that the concentration of trisodium citrate is 1g / 100mL, which is trisodium citrate solution.

[0141] 3. Heat the 50mL tetrachloroauric acid solution prepared in step 1 to boiling, then quickly add 0.5ml of the trisodium citrate solution prepared in step 2, after the color is stable, continue to boil for 10 minutes and then cool naturally, which is the colloidal gold solution.

[0142] 4. Take 100mL of the colloidal gold solution prepared in step 3, and use 1g / 100mL K 2 CO 3 Adjust the pH of the aqueous solution to 8.2, then add 2mg of rabbit anti-human IgG antibody, stir at room temperature for 10 minutes with a magnetic stirrer, then add 0.5g of BSA and 1g of trehalos...

Embodiment 2

[0168]Embodiment 2, the preparation of test strip

[0169] The test strip includes a bottom plate 1, a sample pad 2, a colloidal gold pad 3, a detection pad 4, an absorbent pad 5 and a filter membrane 6. Along the sample flow direction, the sample pad, colloidal gold pad, detection pad and water-absorbing pad are fixed on the bottom plate in sequence.

[0170] The direction along the sample flow is taken as the length direction of the test strip, and the direction perpendicular to the length direction is taken as the width direction of the test strip. The width of the test strip is 1cm. The total length of the test strip is 12cm, wherein the length of the sample pad is 1.5cm, the length of the colloidal gold pad is 1.5cm, the length of the detection pad is 8cm, and the length of the absorbent pad is 1cm.

[0171] A filter membrane is fixed on the upper surface of the sample pad; the filter membrane is circular with a diameter of 1 cm.

[0172] The colloidal gold-labeled rab...

Embodiment 3

[0176] Embodiment 3, the preparation of reaction detection device

[0177] The reaction detection device is used in conjunction with the test strip prepared in Example 2.

[0178] The reaction detection device includes a reaction component and a detection component.

[0179] The detection component is a substrate with a test strip fixing area 8 . The test strip fixing area corresponds to the shape of the test strip, and is provided with through hole A 9 of the filter membrane corresponding to the test strip, through hole B 10 of the detection pad for observing the test strip and C for observing the test strip Line through hole C11. Via B is located between Via A and Via C. The top of the through hole A has an annular side wall protruding from the plane of the substrate. The through hole armor is circular with a diameter of 0.9cm. Through hole B is circular with a diameter of 0.6 cm. The through hole C is circular, rectangular, etc., as long as the C line can be observed....

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Abstract

The invention discloses a device for detecting HIT (Heparin-Induced Thrombocytopenia) antibodies and combined by immunological agglutination and colloidal-gold chromatographic test strip. The system provided by the invention comprises conjugate of platelet factor4 / heparin complex and blue latex microspheres, a test strip and a reaction detection device, wherein the particle diameter of the blue latex microspheres is 0.1-1mum; a sample pad, a colloidal gold pad, a detection pad and a water absorbing pad are fixed on a bottom plate; colloidal-gold-labeled antihuman IgG antibodies are adhered onthe colloidal gold pad; C lines are arranged on the upper surface of the detection pad, and human IgG protein is adhered on the C lines; a filtering membrane is fixed on the sample pad; the pore diameter of the filtering membrane is 0.1-1.5mum; the reaction detection device comprises a reaction part and a detection part; the detection part is a substrate with test-strip fixing areas. The device disclosed by the invention can be used for detecting the HIT antibodies, the detection process is simple, accurate and practical, and qualitative detection can be realized.

Description

technical field [0001] The invention belongs to the field of medical detection and relates to a system for detecting HIT antibodies which combines immunoagglutination and colloidal gold chromatography test strips. Background technique [0002] Heparin is the most commonly used anticoagulant drug in clinical practice. Including unfractionated heparin, low molecular weight heparin, heparin, and other heparin preparations such as aminodextran sulfate. During the use of heparin, heparin / platelet factor 4 complex antibody (AHPF4 antibody, also known as HIT antibody) will be produced, and HIT antibody can cause heparin-induced thrombocytopenia (heparin-induced thrombocytopenia, HIT). The incidence of HIT caused by unfractionated heparin therapy is 1%-5%, and the induction rate of low molecular weight heparin is lower than that of unfractionated heparin. About 50% of HIT patients will be complicated with severe complications - HITwith thrombosis syndrome (HITTS), including deep v...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N33/543
CPCG01N33/54313G01N33/558G01N2800/222
Inventor 高磊占顺利窦鑫杨娅楠刘国强
Owner BEIJING SHUNLEI BIOTECHNOLOGY CO LTD
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