Analytical evaluation of thirty-two severe acute respiratory syndrome 2 lateral flow antigen tests demonstrates sensitivity remains with the SARS-CoV-2 Gamma lineage

Abstract

ABSTRACT Background: The emergence of variants of concern (VOCs) requires an ongoing assessment of the performance of antigen lateral flow tests (Ag-RDTs). The limit of detection (LOD) of 32 Ag-RDTs was evaluated using the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Gamma variant. Methods: Ag-RDTs were performed according to the manufacturer’s instructions with a clinical isolate of the Gamma variant. Results: Twenty-eight of the 32 Ag-RDTs exceeded the World Health Organization criteria. Conclusions: This comprehensive analytical evaluation of Ag-RDTs demonstrated that the test performance was maintained with Gamma VOC.

Keywords

• SARS-CoV-2
• SARS-CoV-2 Gamma variant
• Variant of concern
• Diagnostic tests