The Rapid Antigen Detection Test for SARS-CoV-2 Underestimates the Identification of COVID-19 Positive Cases and Compromises the Diagnosis of the SARS-CoV-2 (K417N/T, E484K, and N501Y) Variants
Barrera-Avalos, Carlos (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Luraschi, Roberto (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Vallejos Vidal, Eva Carolina, (Universidad de Santiago de Chile. Centro de Nanociencia y Nanotecnología)
Mella-Torres, Andrea (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Hernández Vargas, Felipe (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Figueroa, Maximiliano (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Rioseco, Claudia (Universidad de Santiago de Chile. Centro de Biotecnología Acuícola)
Valdés, Daniel (Universidad de Santiago de Chile. Departamento de Biología)
Imarai, Mónica (Universidad de Santiago de Chile. Departamento de Biología)
Acuña-Castillo, Claudio (Universidad de Santiago de Chile. Departamento de Biología)
Reyes-López, Felipe E. (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Sandino, Ana María (Universidad de Santiago de Chile. Departamento de Biología)

Fecha:	2022
Resumen:	Timely detection of severe acute respiratory syndrome due to coronavirus 2 (SARS-CoV-2) by reverse transcription quantitative polymerase chain reaction (RT-qPCR) has been the gold- strategy for identifying positive cases during the current pandemic. However, faster and less expensive methodologies are also applied for the massive diagnosis of COVID-19. In this way, the rapid antigen test (RAT) is widely used. However, it is necessary to evaluate its detection efficiency considering the current pandemic context with the circulation of new viral variants. In this study, we evaluated the sensitivity and specificity of RAT (SD BIOSENSOR, South Korea), widely used for testing and SARS-CoV-2 diagnosis in Santiago of Chile. The RAT showed a 90% (amplification range of 20 ≤ Cq <25) and 10% (amplification range of 25 ≤ Cq <30) of positive SARS-CoV-2 cases identified previously by RT-qPCR. Importantly, a 0% detection was obtained for samples within a Cq value>30. In SARS-CoV-2 variant detection, RAT had a 42. 8% detection sensitivity in samples with RT-qPCR amplification range 20 ≤ Cq <25 containing the single nucleotide polymorphisms (SNP) K417N/T, N501Y and E484K, associated with beta or gamma SARS-CoV-2 variants. This study alerts for the special attention that must be paid for the use of RAT at a massive diagnosis level, especially in the current scenario of appearance of several new SARS-CoV-2 variants which could generate false negatives and the compromise of possible viral outbreaks.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Rapid antigen test ; SARS-CoV-2 detection ; COVID-19 diagnosis ; COVID-19 false negative rapid test for COVID-19 diagnosis ; Pandemic control strategies
Publicado en:	Frontiers in Public Health, Vol. 9 (january 2022) , ISSN 2296-2565

DOI: 10.3389/fpubh.2021.780801
PMID: 35047474

8 p, 4.2 MB

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