tetano
Editor, Senior Moderator
Ann Lab Med
. 2021 Nov 1;41(6):588-592.
doi: 10.3343/alm.2021.41.6.588.
Clinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea
Jaehyeon Lee[SUP] 1 [/SUP], So Yeon Kim[SUP] 2 [/SUP], Hee Jae Huh[SUP] 3 [/SUP], Namsu Kim[SUP] 1 [/SUP], Heungsup Sung[SUP] 4 [/SUP], Hyukmin Lee[SUP] 5 [/SUP], Kyoung Ho Roh[SUP] 6 [/SUP], Taek Soo Kim[SUP] 7 [/SUP], Ki Ho Hong[SUP] 5 [/SUP]
Affiliations
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.
. 2021 Nov 1;41(6):588-592.
doi: 10.3343/alm.2021.41.6.588.
Clinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea
Jaehyeon Lee[SUP] 1 [/SUP], So Yeon Kim[SUP] 2 [/SUP], Hee Jae Huh[SUP] 3 [/SUP], Namsu Kim[SUP] 1 [/SUP], Heungsup Sung[SUP] 4 [/SUP], Hyukmin Lee[SUP] 5 [/SUP], Kyoung Ho Roh[SUP] 6 [/SUP], Taek Soo Kim[SUP] 7 [/SUP], Ki Ho Hong[SUP] 5 [/SUP]
Affiliations
- PMID: 34108286
- DOI: 10.3343/alm.2021.41.6.588
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.