Method for assigning antibody standard and determining minimum detection limit of antibody detection reagent

A method for assigning an antibody standard and detecting a minimum detection limit of an antibody detection reagent, specifically comprising the following steps:

• S1, detection of a neutralized antigen equivalent of an antibody standard or an antibody-containing sample wherein an antigen with a known purity and concentration is subjected to a gradient dilution using a matrix, to obtain a series of antigen diluents with different dilutions;
• and an equal amount of the antibody standard or an equal amount of the antibody-containing sample is added to each of the antigen diluents respectively, and the antibody standard or the antibody-containing sample is bound to the antigen in the antigen diluents;
• after a reaction, each mixture is subjected to an antibody detection using a first antibody detection reagent;
• the antigen-unbound antibody standard or the antigen-unbound antibody-containing sample in each mixture is bound to and detected by the first antibody detection reagent and if a mixture of a certain antigen dilution presents a positive reaction in the test result, an antigen quantity of a mixture with a higher concentration immediately before the present mixture is detected as the neutralized antigen equivalent of the antibody standard or the antibody-containing sample;
• S2, detection of an antibody titer of the antibody-containing sample wherein the antibody-containing sample in the step S1 is subjected to a gradient dilution using a matrix, to obtain a series of sample diluents with different dilutions;
• and the sample diluent of each dilution is subjected to an antibody detection using a second antibody detection reagent the antibody in the sample diluent of each dilution is bound to and detected by the second antibody detection reagent, to obtain the antibody titer of the antibody-containing sample;
• and
• S3, acquisition of the minimum detection limit of the second antibody detection reagent wherein the neutralized antigen equivalent of the antibody-containing sample acquired in the step S1 is multiplied by the antibody titer of the antibody-containing sample acquired in the step S2, to acquire the minimum detection limit of the second antibody detection reagent,
• wherein the first antibody detection reagent comprises a first binding agent specific for the antibody in the antibody standard or the antibody-containing sample, and the second antibody detection reagent comprises a second binding agent specific for the antibody in the antibody-containing sample.