Detection reagent of treponema pallidum IgM (Immunoglobulin M) antigen colloidal gold method and preparation method thereof

Abstract

The invention discloses a detection reagent of a treponema pallidum IgM (Immunoglobulin M) antigen colloidal gold method and a preparation method thereof. The reagent comprises a gold conjugate pad (3), a cellulose nitrate reaction membrane (4), a sample pad (2), water absorbing paper (5) and a PVC (Polyvinyl Chloride) back lining (1), wherein the sample pad, the gold conjugate pad, the cellulose nitrate reaction membrane and the water absorbing paper are sequentially and mutually laminated and adhered on the PVC back lining; the sample pad is laminated on the gold conjugate pad for 2-3 mm, the gold conjugate pad is laminated on the cellulose nitrate reaction membrane for 2-3 mm, and the water absorbing paper is laminated on the cellulose nitrate reaction membrane for 2-3 mm; the gold conjugate pad is coated with an anti-human IgM monoclonal antibody-colloidal gold conjugate; and positions of a quality control region (7) and a detection region (6) of the cellulose nitrate reaction membrane are coated with goat anti-mouse IgG antibody or rabbit anti-mouse IgG antibody and specific gene recombinant treponema pallidum antigen respectively. A production process of a product provided by the invention is simple and easy to control; the detection reagent is easy, convenient and quick in detection; and a result can be read in 25 minutes and is not affected by the IgG antibody and is accurate and reliable.

Description

technical field [0001] The invention belongs to the field of medical examination, in particular to a reagent for detecting Treponema pallidum IgM antibody by colloidal gold immunochromatography and a preparation method thereof. [0002] Background technique [0003] Syphilis is a chronic disease caused by Treponema pallidum (TP) infection. It is a relatively serious disease among sexually transmitted diseases and can be transmitted through sex, blood and mother-to-child routes. Treponema pallidum harms the cardiovascular system and can lead to aortitis, aortic valve insufficiency, aortic aneurysm, etc. It can also damage the skeletal system, causing tissue and organ damage, loss of function, and disability or death; after passing the placenta to the fetus, It can lead to spontaneous abortion, stillbirth or congenital syphilis, etc. 40% -50% of the fetuses of mothers infected in the first trimester are infected, often resulting in stillbirth, stillbirth, miscarriage, prematu...

AI Technical Summary

Problems solved by technology

[0006] IgM antibody detection has long been recommended as a confirmatory test for early congenital syphilis in foreign countries. Although there are a small number of studies on the diagnosis of early syphilis, the confirmation of syphilis, and the monitoring of curative effect in China, it is necessary to separate IgG antibodies first to prevent IgG from interacting with the patient. IgM antibodies compete for specific antigen-binding sites, resulting in false negatives for IgM antibodies

Since the separation technology of IgG antibody and IgM antibody has not been fully mastered, commercialized products have not been formed, and the relevant kits used in clinical practice are basically imported, which brings a large economic burden to patients and the society, and is not convenient for early diagnosis and treatment of syphilis. Confirmation and Control

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