Abstract
The rapid antigen test (RAT) for coronavirus disease (COVID-19) represents a potent diagnostic method in situations of limited molecular testing resources. However, considerable performance variance has been reported with the RAT. We evaluated the clinical performance of Standard Q COVID-19 RAT (SQ-RAT; SD Biosensor, Suwon, Korea), the first RAT approved by the Korean Ministry of Food and Drug Safety. In total, 680 nasopharyngeal swabs previously tested using real-time reverse-transcription PCR (rRT-PCR) were retested using SQ-RAT. The clinical sensitivity of SQ-RAT relative to that of rRT-PCR was 28.7% for all specimens and was 81.4% for specimens with RNA-dependent RNA polymerase gene ( RdRp ) threshold cycle (Ct) values ≤23.37, which is the limit of detection of SQ-RAT. The specificity was 100%. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis was assessed based on the Ct distribution at diagnosis of 33,294 COVID-19 cases in Korea extracted from the laboratory surveillance system of Korean Society for Laboratory Medicine. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis in the Korean population was 41.8%. Considering the molecular testing capacity in Korea, use of the RAT for COVID-19 diagnosis appears to be limited.
Keywords: Coronavirus disease; Korea; Laboratory surveillance; Rapid antigen test; Real-time reverse-transcription PCR.
【저자키워드】 coronavirus disease, Korea, rapid antigen test, laboratory surveillance, Real-time reverse-transcription PCR., 【초록키워드】 COVID-19, coronavirus disease, Safety, Diagnosis, drug, Laboratory, Antigen, Medicine, Nasopharyngeal swab, specificity, rRT-PCR, PCR, Surveillance, nasopharyngeal swabs, COVID-19 diagnosis, limit of detection, Rapid, RdRP, RNA-dependent RNA polymerase, molecular, threshold, distribution, Diagnostic method, Korean, food, clinical sensitivity, Society, COVID-19 case, specimen, SD Biosensor, Standard Q, Real-time reverse-transcription PCR, resources, RNA polymerase gene, tested, reported, evaluated, approved, appear, 【제목키워드】 COVID-19, Test, Simulation, clinical, Rapid, application, performance, Standard Q,