Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit.

ABSTRACT: To develop a national reference panel for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit and establish a quality standard. The cultures of SARS-CoV-2 and other pathogens were collected to establish a national reference panel for SARS-CoV-2 antigen detection. The stability and homogeneity of the reference panel were evaluated. Based on World Health Organization (WHO) guidance and nucleic acid quantitative results, a quality standard reference panel was established. Currently, three generations of SARS-CoV-2 antigen national reference materials with batch numbers 370095-202001, 370095-202202, and 370095-202203 have been successfully established. These national reference panels comprised 8 positive samples, 20 negative samples, 1 repetitive sample, and 1 lo

SUBMITTER: Ma T 

PROVIDER: S-EPMC11895040 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature