Real-World Accuracy of a SARS-CoV-2 Rapid Diagnostic Tests in the Republic of Korea
10.3346/jkms.2022.37.e310
- Author:
Oh Joo KWEON
1
;
Hye Ryoun KIM
;
Mi-Kyung LEE
;
Yong Kwan LIM
Author Information
1. Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea
- Publication Type:Brief Communication
- From:Journal of Korean Medical Science
2022;37(43):e310-
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
