Cross-linked composite used as standard diagnosing reagent replacing positive serum and method for use as standard reagent

Abstract

This invention relates to one positive serum as diagnose agent standard compound, which is processed through single clone antigen technique or antigen immune animal and is the crossed compound of antigen and human immune globulin. This invention also discloses one use method of the compound, which comprises the following steps: a, using antigen immune globulin to get the specific antigen; b, crossing the specific antigen and human immune globulin by the crossing agent; c, diluting the said cross antigen gradient to draw standard curve; d, using the said antigen as standard product for quantitative diagnose test method.

Description

technical field [0001] The invention belongs to the field of biomedicine, and relates to a novel complex that can be used as a diagnostic reagent standard and a method for using it as a diagnostic reagent standard, and particularly relates to a new compound that can be used as a diagnostic reagent standard instead of positive serum. Cross-linked complexes of antigen-specific antibodies and human immunoglobulins and methods for their use as diagnostic reagent standards. Background technique [0002] Antibodies are a class of glycoproteins produced by B lymphocytes in the immune response to antigen stimulation. The basic molecular structure consists of two identical heavy chains (H chains) and two identical light chains (L chains). , the light and heavy chains and between the two heavy chains are connected by disulfide bonds. According to the different heavy chain constant regions, antibodies are divided into 5 classes, namely IgG, IgM, IgA, IgE and IgD. ε and δ chains, poly...

AI Technical Summary

Problems solved by technology

However, using patient serum as a standard product has many disadvantages: 1) It is difficult to obtain patient serum with high titer and high specificity; 2) The antibody titer and specificity vary greatly between individuals, making it difficult to standardize; 3) Since the serum is a polyclonal antibody, it has different antibody types, affinities and specificities, which limits its application; 4) It is expensive, and due to resource constraints, the output of standard products may not be guaranteed

[0010] Human-mouse chimeric antibody can be used as a standard for human serum antibody detection and used to prepare a standard curve (US Patent: 6,015,662), but this method has great limitations: 1) The process is very complicated, including animal immunization, cell fusion , screening of monoclonal antibodies, antibody gene cloning, construction and expression of human-mouse chimeric genetically engineered antibodies, etc., take a long time and cost high; rebuild

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