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

Rev Soc Bras Med Trop. 2022 Jun 6:55:e0016. doi: 10.1590/0037-8682-0016-2022. eCollection 2022.

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.

MeSH terms

  • COVID-19* / diagnosis
  • Humans
  • SARS-CoV-2*
  • Sensitivity and Specificity

Supplementary concepts

  • SARS-CoV-2 variants