Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Abstract

Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription–polymerase chain reaction (rRT-PCR) is limited. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required. Here, using 1503 nasopharyngeal swabs, we compared the diagnostic performance of four RAT kits (Abbott Panbio™ COVID-19 Ag Rapid Test, SD Biosensor Standard™ Q COVID-19 Ag Test, Humasis COVID-19 Ag Test, and SG Medical Acrosis COVID-19 Ag Test) to the cycle threshold (Ct) values obtained from rRT-PCR. The precision values, area under the curve values, SARS-CoV-2 variant detection ability, and non-SARS-CoV-2 specificity of all four kits were similar. An assay using the Acrosis kit had a significantly better positive detection rate with a higher recall value and cut-off value than that using the other three RAT kits. During the current COVID-19 pandemic, the Acrosis kit is an effective tool to prevent the spread of SARS-CoV-2 in communities.

Evaluation of Multiplex Rapid Antigen Tests for the Simultaneous Detection of SARS-CoV-2 and Influenza A/B Viruses

“…In previous studies, the sensitivity of RAT kits from three different manufacturers (GenBody Inc., SG Medical, and SD BIOSENSOR Inc.) for SARS-CoV-2 was evaluated using singleplex tests. The sensitivity ranged from 79.9% to 95.6% for GenBody, 93.4% for InstaView, and 55.7% to 98.3% for STANDARD Q [16,[36][37][38][39][40][41]. The clinical performance of multiplex RAT kits has been reported to be similar to that of singleplex RAT kits [42].…”

“…All RAT kits in this study targeted the N protein for qualitative viral detection. The RAT procedure was modified from a previously reported procedure [16]. Briefly, 60 µL of transport medium was mixed with 60 µL of the buffer enclosed in each kit.…”

“…Compared with rRT-PCR assays, RATs are simple to perform and provide test results within minutes. Moreover, RAT results can be read with the naked eye, without the need for expensive laboratory equipment [16]. Previous studies have evaluated the clinical performance of commercially available RAT kits for the detection of a single pathogen (SARS-CoV-2 or influenza A/B viruses).…”

“…Previous studies have evaluated the clinical performance of commercially available RAT kits for the detection of a single pathogen (SARS-CoV-2 or influenza A/B viruses). Compared with rRT-PCR methods, the reported sensitivity of RATs varies substantially (53.8-100%) depending on the sample distribution, whereas the specificity of RATs is generally comparable to that of rRT-PCR (81.8-100%) [16][17][18]. Other studies have evaluated the clinical performance of commercially available RAT kits for the simultaneous detection of SARS-CoV-2, influenza A virus (FluA), and influenza B virus (FluB) [19].…”