Performance Evaluation of Two Kinds of Rapid Antigen Test Kits for Detection of COVID-19 Infection.

ABSTRACT

BACKGROUND: The diagnostic standard for COVID-19 infection is real-time reverse transcription-polymerase chain reaction (rRT-PCR) of nasopharyngeal swab and oropharyngeal swab specimens. Rapid antigen tests are cheaper and easier to use than the rRT-PCR method. Although the COVID-19 pandemic is settling down, seasonal epi¬demic is expected. In this study, the performance of two rapid antigen test kits was evaluated based on rRT-PCR test results. METHODS: A total of 346 residual samples was tested by the PowerChek SARS-CoV-2 Real-time PCR Kit or STAN-DARD M nCoV Real-Time-Detection kit, STANDARD Q COVID-19 Ag test kit (SQ RAT), and ND COVID-19 Ag test kit (ND RAT). RESULTS: Compared to rRT-PCR as the standard method, the SQ RAT test kit yielded 77.1% sensitivity (101/131) and 100% specificity (215/215), and the ND RAT yielded 89.3% sensitivity (117/131) and 100% specificity (215/ 215). Both RATs showed sensitivity greater than 85% in samples with RdRp gene Ct value less than 25. There was a false-negative case suspected of prozone phenomenon. CONCLUSIONS: Both RATs showed significant performance, but users should beware of the prozone phenomenon.