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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

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

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