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KMID : 0191120220370430310
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Journal of Korean Medical Science
2022 Volume.37 No. 43 p.310 ~ p.310
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Real-World Accuracy of a SARS-CoV-2 Rapid Diagnostic Tests in the Republic of Korea
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Kweon Oh-Joo
Kim Hye-Ryoun
Lee Mi-Kyung
Lim Yong-Kwan
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Abstract
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Antigen rapid diagnostic tests (RDTs) became the most important tool for the diagnosis of the coronavirus disease 2019 (COVID-19), however there have been very few evaluations of the accuracy of the RDTs in actual use. In this study, we investigated the performance accuracy of the RDT, the STANDARD Q COVID-19 Ag (STANDARD Q), in the Republic of Korea. We collected a total of 5,792 results that underwent both RDT and reverse transcription polymerase chain reaction simultaneously, and overall sensitivity and specificity of the STANDARD Q were 57.6% and 99.9%, respectively. With binomial logistic regression analysis, we estimated that about half of the COVID-19 patients with a cycle threshold value of 25 for E and RdRP were RDT-negative. These results suggest that the clinical sensitivity of RDTs against severe acute respiratory syndrome coronavirus 2 is considerably low in a real-world setting, and we recommend that limitations of RDTs should be considered when setting up COVID-19 test strategies.
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KEYWORD
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COVID-19, SARS-CoV-2, Rapid Diagnostic Test
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