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.
【저자키워드】 SARS-CoV-2 detection, rapid antigen test, COVID-19 diagnosis, COVID-19 false negative rapid test for COVID-19 diagnosis, pandemic control strategies, 【초록키워드】 SARS-CoV-2, coronavirus, pandemic, variant, SARS-CoV-2 variant, Diagnosis, Antigen, Severe acute respiratory syndrome, polymerase chain reaction, amplification, RT-qPCR, Outbreaks, Viral, Sensitivity and specificity, SARS-CoV-2 variants, Single nucleotide polymorphism, N501Y, K417N, false negatives, gold, Viral variants, SNP, E484K, Beta, reverse transcription, methodology, circulation, respiratory, South Korea, Quantitative, single nucleotide polymorphisms, False negative, Cq value, nucleotide, Detection sensitivity, Chain Reaction, reverse transcription quantitative polymerase chain reaction, acute respiratory syndrome, appearance, detection efficiency, compromise, positive, SD Biosensor, new SARS-CoV-2, polymerase chain, evaluate, evaluated, generate, applied, less, faster, was obtained, diagnosis of COVID-19, 【제목키워드】 COVID-19, SARS-CoV-2, Test, detection, Rapid, identification, the SARS-CoV-2,