Latex-enhanced immunoturbidimetry kit for measuring Helicobacter pylori antibody as well as preparation method and application thereof

Abstract

The invention discloses a latex-enhanced immunoturbidimetry kit for measuring a Helicobacter pylori antibody as well as a preparation method and application thereof. The kit comprises a diluent, latex reagent and blank liquid of Helicobacter pylori antigen, a standard product and a quality control product, wherein the Helicobacter pylori antigen can be one or more of full-tropina antigen of Helicobacter pylori, urease antigen of Helicobacter pylori, cytotoxin-related protein A antigen of Helicobacter pylori or cell vacuole toxin A antigen of Helicobacter pylori; the latex reagent is a mixture of two latex granules which have different particle sizes and are adsorbed by Helicobacter pylori; and the Helicobacter pylori antibody for preparing the standard product and the quality control product is derived from IgM (immunoglobulin M) and / or IgG (immunoglobulin G) in serum of a patient infected by Helicobacter pylori. The kit is suitable for various full-automatic biochemical analyzers and semiautomatic biochemical analyzers, and has the advantages of rapid detection, high sensitivity, strong specifically, good accuracy and the like.

Description

technical field [0001] The invention relates to a detection kit, in particular to a latex immune kit for detecting Helicobacter pylori antibody in human serum and a preparation method thereof. The invention belongs to the technical field of biological detection Background technique [0002] Helicobacter pylori (HP for short) is a unipolar, multi-flagellated, blunt-rounded end, spiral-curved bacterium, Gram-negative, and often presents a typical spiral or arc on the surface of gastric mucosal epithelial cells . [0003] Helicobacter pylori infection is the main pathogenic factor of chronic active gastritis, peptic ulcer and gastric moving membrane-associated lymphoid tissue (MALT) lymphoma, and is closely related to the occurrence of gastric cancer. 1994 World Health Organization / International Cancer Research The agency (WHO / IARC) defines Helicobacter pylori as a class I carcinogen. The detection rate of Helicobacter pylori in gastric mucosal biopsy specimens of patients w...

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Problems solved by technology

This method is simple, rapid and sensitive, but it may also produce false positives due to the presence of other bacteria containing urease

In addition, samples with recent use of drugs that reduce gastric bacterial load or directly inhibit urease activity can produce false negatives

[0008] 2. Pathological detection method: by carrying out section staining inspection on gastric mucosa tissue, it can be confirmed by directly displaying HP thalline, wherein the detection rate of silver staining method is high, but the differences observed by different pathologists have certain significance for the diagnosis of gastric atrophy samples. certain difficulty

[0009] 3. The bacterial culture method takes gastric mucosal biopsy tissue for HP culture, but it is not suitable for general application due to less cultured bacteria, more complicated operation process, longer time period, and high cost

This method has high sensitivity and can be quantified, but there is a certain risk of radioactivity, and it is difficult to be widely used due to equipment limitations.

[0013] 2. PCR detection method: mainly detect HP urease (UReA) gene and toxin-related protein A (CagA) gene in gastric juice and mucous membrane, but the operation is complicated and easy to be polluted, and the professional knowledge and operation technology requirements of the inspectors are relatively high. And greatly increase the economic expenditure of patients, so the clinical application is relatively limited

[0014] 3. Immuno-serological method: At present, existing methods include enzyme-linked immunosorbent assay, western blotting and colloidal gold method, which provide a favorable and convenient means for the epidemiological investigation of HP, but the detection speed is slow, except enzyme-linked immunosorbent assay can be used Except for the automatic enzyme immunoassay analyzer (which takes 2-3 hours and has many steps), the rest need to be operated manually. The test results obtained by patients are qualitative analysis, which is not suitable for treatment monitoring and efficacy evaluation

[0015] At present, although there are many methods for detecting Helicobacter pylori infection, there is no suitable biochemical analyzer that can be easily, quickly, mass-produced and quantitatively detected

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