Harmless Positive Control for Indirect ELISA Detection

Abstract

The invention provides a harmless positive reference substance for detection pathogens through indirect enzyme linked immunosorbent assay. The positive reference substance is prepared from mixing monoclonal antibody or polycolonal antibody of anti-mouse envelope antigen with monoclonal antibody or polycolonal antibody of anti-mouse IgG according to the mole ratio of (1:32)-(2:1), and the monoclonal antibody or polycolonal antibody of the anti-mouse envelope antigen is an IgG antibody reacting with envelop antigen virus and obtained by gene expression, chemical modification and immunity methods; the monoclonal antibody or polycolonal antibody of anti-mouse IgG is an antibody capable of reacting with mouse IgG and obtained by adopting the gene expression, chemical modification and immunity methods. The sources problem of a positive control material of an indirect diagnostic EIA kit can be solved by utilizing the immunology method, and the potential risk caused the use of serum can be avoided.

Description

technical field [0001] The invention belongs to the field of immunological detection, and in particular relates to a harmless positive control substance used for indirect enzyme-linked immunosorbent assay detection and its preparation method and application. Background technique [0002] Indirect enzyme immunoassay reagent is a commonly used method for detecting antibodies. The principle is to use an enzyme-labeled anti-antibody to detect the test antibody that binds to a solid-phase antigen, so it is called an indirect method. The specific operation is to link the specific antigen with a solid phase carrier to form a solid phase antigen. Wash to remove unbound antigen and impurities. Add diluted test serum and incubate the reaction. The specific antibody in the serum combines with the solid-phase antigen to form a solid-phase antigen-antibody complex. After washing, only the specific antibody remains on the solid phase carrier, and other components in the serum are wash...

AI Technical Summary

Problems solved by technology

In the production of the kit, the positive control is made by inactivating and diluting the positive serum after infection with human or animal pathogens. This serum can only come from virus-infected patients. Due to the need to maintain antibody activity, inactivation is not allowed. The effect is good. High temperature and high pressure or inactivation of chemical reagents, all of which have biological safety problems in the process of preparation, transportation and use, not only have risks to direct contacts and the environment, but also have the risk of infection, transmission and spread of source or animal source pathogens. The manufacturer's kit instructions all emphasize this issue