Method and kit for detecting TORCH IgM antibodies and preparation method of kit

Abstract

The invention discloses a kit for detecting TORCH IgM antibodies. The kit comprises a solid carrier which is coated with an antibody combined with the TORCH IgM antibodies, a TORCH antigen which is marked with lanthanide, a TORCH IgM antibody calibrator, a sample diluent, an experiment buffering solution, a concentration cleaning solution and an enhancement solution. The kit can simultaneously detect multiple pathogene IgM antibodies in TORCH pathogene under the same detection condition and is high in sensitivity, high in specificity, good in precision, high in accuracy, little in blood consumption amount, rapid, convenient and favorable for early diagnosis on the infection of the TORCH pathogene. The method has the characteristic that the detection linear range is wide, the diluting times or diluting ratio of a high-value sample can be reduced, and the accuracy of a detection result can be improved.

Description

technical field [0001] The invention relates to a method and a kit for TORCH IgM antibodies, in particular to a method for detecting TORCH IgM antibodies based on multiple label time-resolved fluorescence immunoassay, a kit and a preparation method for the kit. Background technique [0002] The term TORCH was formed by the American scholar Nahmias in 1971 by combining the first letters of the English nouns of pathogens that would cause infection of embryos (fetus) in the uterus, cause abortion, or even cause birth defects or abnormal development after several pregnant women became ill. Refers to a group of pathogens: T is Toxoplasma gondii; O is others, such as hepatitis B virus, HIV virus, Treponema pallidum, etc.; R is rubella virus (Rubellavirus); C is cytomegalovirus (Cytomegalovirus); H stands for herpes simplex virus. [0003] The above four pathogens have the following points in common: 1. They can spread vertically through the placenta and cause intrauterine infecti...

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Problems solved by technology

[0009] At present, a single kit is often used to detect TORCH IgM antibodies, that is, one kit can only detect IgM antibodies of one pathogen in TORCH pathogens. This method has the following disadvantages: 1. There are many detection steps, especially the manual method is easy 2. It takes a long time to add samples, and the detection time is long, which is time-consuming and laborious; 3. The large amount of samples required leads to an increase in the amount of blood collected

Due to radioactive pollution, RIA has a great impact on the environment and operators, and the intra-assay and inter-assay variation is large, making it difficult to automate; ELISA uses macromolecular enzyme labels, and the enzyme is easily inactivated. This detection method relies on colorimetry or polarized light. The technology is subject to too many interference factors (even the excellent "tube ELISA", the change of the shape of the test tube will affect the results of the test), and its sensitivity, linearity and stability cannot be higher than that of RIA; the chemiluminescence of CLIA is usually It is completed in an instant, the luminescence peak decays quickly, and the temperature and pH value have a great influence on the luminescence. Such factors affect the application of this type of method; ECLI is still a non-open system, and the reagents rely on imports. The reagents are expensive, maintenance and detection costs High, which also limits its promotion and application

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