Secondary antibody competition immunoturbidimetric assay kit and method for making and using same

Abstract

The invention discloses a latex-enhanced two-antibody competitive immunoturbidimetric assay kit as well as preparation and application methods thereof. According to the precipitation or agglutinationphenomenon of an immune complex formed by an antigen-antibody reaction and the principle of latex-enhanced immunological turbidimetry, on the basis of precipitation or agglutination formed by secondary antibody and primary antibody reaction, a secondary antibody-latex connector is prepared, antibody titer of primary antibodies is determined by the secondary antibody-latex connector, the quantity of the primary antibodies is limited, and during measuring of a reaction system, when antigens exist, the antigens compete with secondary antibodies for binding sites of the primary antibodies, so thatthe primary antibodies and the secondary antibodies are inhibited from forming the immune complex and agglutination or precipitation effect is reduced. A latex particle preparation process can be standardized by universal secondary antibody-latex, the product quality difference of the kits prepared from different kinds of latex and different antibodies with different methods is reduced, and the method is particularly suitable for clinical kit preparation; when the antigens are excessive, a false-negative result caused by hook effect can be eliminated.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a latex-enhanced secondary antibody competitive immunoturbidimetric assay kit and a method for making and using the same. Background technique [0002] Immunoturbidimetric analysis methods have been widely used clinically, and dozens of kits have been used clinically. At the same time, the discovery of new biomarkers will continue to promote the production of this new kit. At present, there are mainly two types. One is to directly add the antibody into the reaction system. Under certain conditions, the antigen and antibody react to form an immune complex, which causes agglutination or precipitation to change the turbidity of the system. This turbidity change is related to the system. There is a positive correlation between the antigen concentration in the sample, and the antigen concentration in the sample can be determined accordingly. This method is usually called turbi...

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Problems solved by technology

In order to avoid false negative results due to excess antigen, some people use the method of pre-reaction threshold judgment for the determination of excess antigen. Through short-term pre-reaction, the threshold value of turbidity change is given to screen out the samples with excess antigen, and dilute This method can effectively avoid "false negative" results, but for different analytes, due to different antibodies, the given thresholds are different. In addition, the quality of antigens and antibodies in different batches is not complete. The same also affects the setting of the threshold value. In addition, this method is different from the conventional immunoassay process. It needs to design a special measurement program or special equipment, and this analysis process cannot be realized on a general automatic biochemical analyzer.

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