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.
All Keywords
【초록키워드】 SARS-CoV-2, coronavirus, VoC, variant, variants of concern, severe acute respiratory syndrome Coronavirus, variants, Antigen, Lateral flow test, VOCs, limit of detection, Gamma, Ag-RDT, RDTs, criteria, Health Organization, World Health Organization, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, World Health Organization criteria, Ag-RDTs, performed, evaluated, demonstrated, exceeded, 【제목키워드】 Antigen, lateral flow, sensitivity, Lineage, Gamma, acute respiratory syndrome, the SARS-CoV-2,
【초록키워드】 SARS-CoV-2, coronavirus, VoC, variant, variants of concern, severe acute respiratory syndrome Coronavirus, variants, Antigen, Lateral flow test, VOCs, limit of detection, Gamma, Ag-RDT, RDTs, criteria, Health Organization, World Health Organization, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, World Health Organization criteria, Ag-RDTs, performed, evaluated, demonstrated, exceeded, 【제목키워드】 Antigen, lateral flow, sensitivity, Lineage, Gamma, acute respiratory syndrome, the SARS-CoV-2,
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{{ 배경: }} 우려되는 변이체(VOC)의 출현으로 항원 측면 유동 검사(Ag-RDT)의 성능에 대한 지속적인 평가가 필요합니다. 32개의 Ag-RDT의 검출 한계(LOD)는 중증 급성 호흡기 증후군 코로나바이러스 2(SARS-CoV-2) 감마 변이체를 사용하여 평가되었습니다.
{{ 방법: }} Ag-RDT는 감마 변이체의 임상 분리물을 사용하여 제조업체의 지침에 따라 수행되었습니다.
{{ 결과: }} 32개의 Ag-RDT 중 28개가 세계보건기구 기준을 초과했습니다.
{{ 결론: }} Ag-RDT에 대한 이 종합적인 분석 평가는 테스트 성능이 감마 VOC로 유지되었음을 보여주었습니다.