J Korean Med Sci.  2022 Oct;37(43):e310. 10.3346/jkms.2022.37.e310.

Real-World Accuracy of a SARS-CoV-2 Rapid Diagnostic Tests in the Republic of Korea

• Kweon OJ
• Kim HR
• Lee MK
• Lim YK

• KMID: 2534824
• DOI: http://doi.org/10.3346/jkms.2022.37.e310

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.

Keyword

COVID-19; SARS-CoV-2; Rapid Diagnostic Test

Figure

• 

  Fig. 1 Binomial logistic regression analysis for the percentage of positive results of the STANDARD Q COVID-19 Ag according to the Ct of E (A) and RdRP (B) in the SARS-CoV-2 RT-PCR assay.COVID-19 = coronavirus disease 2019, Ct = cycle threshold, SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2, RT-PCR = reverse transcription polymerase chain reaction, LOD = limit of detection.

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