1.Key Laboratory of Bioanalysis and Metrology for State Market Regulation, Shanghai Institute of Measurement
and Testing Technology, Shanghai 201203, China
2. Institutional Center for Shared Technologies and Facilities, Pathogen Discovery and Big Data Platform, Shanghai Institute of Immunity and Infection, Chinese Academy of Sciences, Shanghai 200031, China
Abstract：A reference material (RM) of inactivated influenza A (H1N1) virus was developed. The RM was made of artificially cultured natural virus as raw materials. After chemical inactivation and verification of the inactivation effect, the copy number concentration was determined by digital PCR (dPCR) in different laboratories. The homogeneity, stability and uncertainty of the RM were evaluated in detail. As the results demonstrated, the RM can be stably stored for more than 5 months under -80~-70℃. The final certified value of reference materials was (1384.5±249.3) copies/μL (k=2). The RM can be used for the metrological traceability and quality control in the whole process of influenza A virus H1N1 detection and help to improve the accuracy and reliability of related nucleic acid test results.
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2024, Vol. 45 
