Comprehensive, Comparative Evaluation of 35 Manual SARS-CoV-2 Serological Assays.

ABSTRACT: The onset of the coronavirus disease 2019 (COVID-19) pandemic resulted in hundreds of in vitro diagnostic devices (IVDs) coming to market, facilitated by regulatory authorities allowing "emergency use" without a comprehensive evaluation of performance. The World Health Organization (WHO) released target product profiles (TPPs) specifying acceptable performance characteristics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay devices. We evaluated 26 rapid diagnostic tests and 9 enzyme immunoassays (EIAs) for anti-SARS-CoV-2, suitable for use in low- and middle-income countries (LMICs), against these TPPs and other performance characteristics. The sensitivity and specificity ranged from 60.1 to 100% and 56.0 to 100%, respectively. Five of 35 test kits reported no

SUBMITTER: Dimech W 

PROVIDER: S-EPMC10269659 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature