Field evaluation of seven SARS-COV-2 antigen assays. Issue 2 (February 2022)

• Record Type: Journal Article
• Authors: Lim, Yong Kwan; Kweon, Oh Joo; Kim, Hye Ryoun; Kim, Tae-Hyoung; Lee, Mi-Kyung
• Is Part Of: Journal of infection and public health. Volume 15:Issue 2(2022)
• Page Start: 199
• Page End: 202
• Publication Date: 2022-02
• Subjects: COVID-19 -- SARS-CoV-2 -- Rapid diagnostic test -- Evaluation; Communicable diseases -- Periodicals; Public health -- Periodicals; Epidemiology -- Periodicals; Nosocomial infections -- Prevention -- Periodicals; Medical microbiology -- Periodicals; 614.4
• DOI: 10.1016/j.jiph.2021.12.012
• Languages: English
• ISSNs: 1876-0341

Abstract

Abstract: There is a global demand for rapid diagnostic tests (RDTs) for Coronavirus disease 2019 (COVID-19), and the interest in their clinical compliance is growing. In this study, we evaluated the clinical compliance of seven different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen RDTs. Nasopharyngeal/oropharyngeal swab specimens from COVID-19-confirmed cases and reverse-transcription PCR (RT-PCR) screening were used to evaluate the performance of seven RDTs. Using the RT-PCR and RDT results, we predicted the cycle threshold (Ct) of each target gene ( E, RdRP, and N genes) which 50% (Ct50 ) and 95% (Ct95 ) detection rates were achieved in the RDTs. A total of 482 specimens were enrolled in our study: 316 specimens from COVID-19-confirmed cases and 166 RT-PCR-negative specimens. The median values of Ct50 and Ct95 for the seven RDTs were in the ranges of ranged 24.3–30.9 and 19.3–22.6 for E, 25.5–31.5 and 20.9–24.0 for R dRP, and 26.8–32.3 and 22.7–25.7 for N, respectively. The RDTs showed acceptable compliance only for specimens with high viral burdens (Ct < 20). However, the false-negative rate increased by more than 50% for most of the RDTs in low-viral burden specimens (Ct> 30). These results suggest that RDTs should not be used without molecular assays for COVID-19 screening for asymptomatic patients because of their high false-negative rates.