Clinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea
Annals of Laboratory Medicine 2021³â 41±Ç 6È£ p.588 ~ p.592
ÀÌÀçÇö(Lee Jae-Hyeon) - Jeonbuk National University Medical School and Hospital Department of Laboratory Medicine
±è¼Ò¿¬(Kim So-Yeon) - National Medical Center Department of Laboratory Medicine
ÇãÈñÀç(Huh Hee-Jae) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Laboratory Medicine and Genetics
±è³²¼ö(Kim Nam-Su) - Jeonbuk National University Medical School and Hospital Department of Laboratory Medicine
¼ºÈï¼·(Sung Heung-Sup) - University of Ulsan College of Medicine Asan Medical Center Department of Laboratory Medicine
ÀÌÇõ¹Î(Lee Hyuk-Min) - Yonsei University College of Medicine Severance Hospital Department of Laboratory Medicine
³ë°æÈ£(Roh Kyoung-Ho) - National Health Insurance Service Ilsan Hospital Department of Laboratory Medicine
±èÅüö(Kim Taek-Soo) - Seoul National University College of Medicine Seoul National University Hospital Department of Laboratory Medicine
È«±âÈ£(Hong Ki-Ho) - Yonsei University College of Medicine Severance Hospital Department of Laboratory Medicine
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 ¡Â23.37, 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.
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Coronavirus disease, Real-time reverse-transcription PCR, Laboratory surveillance, Rapid antigen test, Korea
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À¯È¿¼º°á°ú(Recomendation)
This study revealed that SQ-RAT has limited clinical sensitivity for COVID-19 diagnosis in the Korean population; 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.