Development of Reference Material of SARS-CoV-2 Genomic RNA

ABSTRACT

High and low concentrations of reference material of SARS-CoV-2 genomic RNA were developed(GBW(E)091098 and GBW(E)091099)based on the inactivated RNA extraction of the novel coronavirus from infected patients as the potential material,of which the concentrations of E,ORF1ab and N gene were qualified by digital PCR. The reference values with expanded uncertainty of high concentration of reference material were(1.06±0.11)×103 copy/μL,(8.96±0.61)×102 copy/μL and(1.73±0.1)×103 copy/μL,respectively. And those for the low concentration of reference material were(1.29±0.26)×102 copy/μL,(9.5±1.8)×101 copy/μL and(2.05±0.31)×102 copy/μL,respectively. The reference material here developed had been widely applied to method establishment of nucleic acid detection for SARS-CoV-2,quality control for detection kits and testing laboratory. © 2021, Acta Metrologica Sinica Press. All right reserved.