1. Đánh giá phương pháp và giá trị lâm sàng của xét nghiệm Anti-Sars-Cov-2 trên hệ thống Roche Cobas e801

Abstract

COVID-19 disease caused by SARS-CoV-2 virus is a global health problem. The test to detect antibodies against SARS-CoV-2 plays a role in assessing the immune response of infected patients and studying the epidemiology of a large population. The Elecsys Anti-SARS-CoV-2 assay performed on the Cobas e801/Roche immune system uses electrochemiluminescence immunoassay principle to detect antibodies against viral N-proteins. This is a newly deployed test at the Department of Clinical Laboratory - Hanoi Medical University Hospital. Therefore, to ensure the test quality, the laboratory performed test method verification. We evaluated the precision, sensitivity and specificity according to the CLSI EP15A3 and EP12A2 guidelines. The results achieved the repeatability and reproducibility in accordance with the manufacturer's claims; the sensitivity was 41.18% at the 0-6 day period, 53.85% at the 7-13 day period, 87.5% at the 14-day period and 99.79% specificity. Our laboratory continues to use the Elecsys Anti-SARS-CoV-2 assay performed on the Cobas e801/Roche immune system.