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Clinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea

Authors
 Jaehyeon Lee  ;  So Yeon Kim  ;  Hee Jae Huh  ;  Namsu Kim  ;  Heungsup Sung  ;  Hyukmin Lee  ;  Kyoung Ho Roh  ;  Taek Soo Kim  ;  Ki Ho Hong 
Citation
 ANNALS OF LABORATORY MEDICINE, Vol.41(6) : 588-592, 2021-11 
Journal Title
ANNALS OF LABORATORY MEDICINE
ISSN
 2234-3806 
Issue Date
2021-11
MeSH
COVID-19 / diagnosis* ; COVID-19 / virology ; COVID-19 Testing / methods ; Humans Nasopharynx / virology ; RNA, Viral / analysis ; RNA, Viral / metabolism ; RNA-Dependent RNA Polymerase / genetics* ; Real-Time Polymerase Chain Reaction ; Republic of Korea ; SARS-CoV-2 / genetics* ; SARS-CoV-2 / isolation & purification
Keywords
Coronavirus disease ; Korea ; Laboratory surveillance ; Rapid antigen test ; Real-time reverse-transcription PCR
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.
Files in This Item:
T999202138.pdf Download
DOI
10.3343/alm.2021.41.6.588
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Lee, Hyuk Min(이혁민) ORCID logo https://orcid.org/0000-0002-8523-4126
Hong, Ki Ho(홍기호) ORCID logo https://orcid.org/0000-0002-5700-9036
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/188117
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