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

Frontiers in Public Health

Carlos Barrera-Avalos¹  Roberto Luraschi¹  Andrea Mella-Torres¹  Felipe Hernández¹  Maximiliano Figueroa¹  Claudia Rioseco¹  Eva Vallejos-Vidal²  Mónica Imarai³  Claudio Acuña-Castillo³  Ana María Sandino³  Daniel Valdés³  Felipe E. Reyes-López⁵ 

[1] Centro de Biotecnología Acuícola, Facultad de Química y Biología, Universidad de Santiago de Chile, Santiago, Chile;Centro de Nanociencia y Nanotecnología CEDENNA, Universidad de Santiago de Chile, Santiago, Chile;Department of Biology, Faculty of Chemistry and Biology, University of Santiago de Chile, Santiago, Chile;Department of Cell Biology, Physiology and Immunology, Universitat Autònoma de Barcelona, Bellaterra, Spain;Facultad de Medicina Veterinaria y Agronomía, Universidad de Las Américas, Santiago, Chile;

关键词: rapid antigen test;    SARS-CoV-2 detection;    COVID-19 diagnosis;    COVID-19 false negative rapid test for COVID-19 diagnosis;    pandemic control strategies;   

DOI  :  10.3389/fpubh.2021.780801

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown