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

• DOI: 10.1016/j.bsheal.2023.10.002
• Publication Date: 2023-10-21T04:42:16Z
• Authors: Tingting Ma; Donglai Liu; Keliang Lyu; Tingting Gao; Dawei Shi; Lanqing Zhao; Shu Shen; Yabin Tian; Sihong Xu; Haiwei Zhou
• Keywords: National standard

To develop a national reference panel for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit and establish quality standard. The cultures of SARS-CoV-2 other pathogens were collected to detection. stability homogeneity the evaluated. Based on World Health Organization (WHO) guidance nucleic acid quantitative results, standard was established. Currently, three generations materials with batch numbers 370095–202001, 370095–202202, 370095–202203 have been successfully These panels comprised 8 positive samples, 20 negative 1 repetitive sample, lower limit sample. meet requirements. standards are as follows: coincidence rates 8/8 20/20, respectively. 10 test results medium low-concentration should be positive, color rendering uniform (or coefficient variance not higher than 20.0 %). at least 5 × 105 Units/mL (Equivalent copies/mL), concentrations above must positive. A has As reagents, played crucial role in pre-marketing evaluation post-marketing supervision China.