Method for detecting immune complex in mouse blood sample

Abstract

The invention discloses a method for detecting an immune complex in a mouse blood sample. The immune complex comprises a humanized or humanized biomacromolecule drug and an anti-drug antibody which is combined with the humanized or humanized biomacromolecule drug and is generated in a mouse body. The method comprises the following steps: detecting serum of a plurality of mice without treatment history by applying an ELISA method; obtaining a plurality of first negative control signal values; selecting and mixing a plurality of mouse serums with a first negative control signal value lower than the critical quantile interval to obtain a negative control, and detecting the negative control by applying an ELISA method to obtain a second negative control signal value; detecting the to-be-detected sample by applying an ELISA method to obtain a signal value of the to-be-detected sample, and if the signal value of the to-be-detected sample is not lower than a critical value multiplied by a second negative control signal value, judging that the to-be-detected sample is positive, wherein the critical value is the sum of the average value of the S / N values and 2-10 times of the standard deviation of the S / N values, and the critical quantile interval is between 25% quantile and 75% quantile.

Description

technical field [0001] The invention relates to the field of detection of immune complexes, in particular to a method for detecting immune complexes in mouse blood samples. Background technique [0002] With the continuous development of antibody technology and the continuous emergence of new antibodies, therapeutic protein drugs have become one of the fastest growing fields in the pharmaceutical industry. With the deepening of research on therapeutic protein drugs, more and more attention has been paid to the impact of immunogenicity problems during the administration of therapeutic protein drugs on the safety and effectiveness of drugs. As an important part of therapeutic protein drug development, safety evaluation and long-term effectiveness evaluation, in the entire drug development and safety and effectiveness trials, the detection and evaluation of immunogenicity has been approved by the Center for Drug Evaluation of the State Drug Administration (CenterFor Drug Evalu...

AI Technical Summary

Problems solved by technology

However, the immune complexes detected by this type of complement detection method are not specific to the immune complexes mediated by anti-drug antibodies-drugs, and the test results cannot truly reflect the immune complexes mediated by anti-drug antibodies

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