Retrovirus detection method

Abstract

The invention discloses a retrovirus detection method. The method comprises the following steps: (1) selecting host cells that support the replication of the retrovirus; (2) culturing a sample to be tested with the host cells together; (3) collecting supernate, inoculating an indicating cell line, and detecting whether the supernate is polluted by retrovirus or not. According to the provided method, a co-culture method is used to detect the retrovirus, the sensitivity and specificity of retrovirus detection are greatly improved, compared with the conventional retrovirus detection method, the method can be widely used to detect biological products such as monoclonal antibody, in-vitro diagnosis products, and the like, and the method can also be used to detect the biological safety of the endogenous pollution elimination / inactivation step during the biological product production process.

Description

technical field [0001] The invention relates to the field of biology, in particular to the field of safety detection of biological products, and more specifically to a detection method for retroviruses. Background technique [0002] Biological products are products made from microorganisms, cells, animal or human tissues and body fluids, etc., using traditional or modern biotechnology and used for the prevention, treatment and diagnosis of human diseases. Biological products for human use include: bacterial vaccines (including toxoids), viral vaccines, antitoxins and antiserum, blood products, cytokines, growth factors, enzymes, in vivo and in vitro diagnostic products, and other biologically active agents, such as toxins, Antigens, allergens, monoclonal antibodies, antigen-antibody complexes, immune regulation and probiotics, etc. [0003] During the production and application of biological products, some problems such as safety will be encountered. For example, antibody ...

AI Technical Summary

Problems solved by technology

[0004] Traditional retrovirus detection methods mainly include infectivity experiment technology, PCR method or electron microscope method, etc. The main problem of these detection methods is that the detection sensitivity and specificity are not high, and the mainstream PCR method for detecting viral gene fragments Criticism exists

Because the virus detection is mostly after the virus is inactivated, and the genome of the virus may be cleaved into small fragments after the virus is inactivated, and the molecular weight of the amplification product of quantitative PCR is generally very small, so it is easy to cause false positives.

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