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Highlights We compared analytical sensitivity and clinical sensitivity for the three commercially available rapid antigen detection (RAD) kits for detection of SARS-CoV-2 virus. The three RAD kits varied 102 to 105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9% to 71.4% for detecting respiratory specimens from COVID-19 patients. Understanding the clinical characteristics of different RAD kits can increase the likelihood of positive results.

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Background and objective: RT-PCR is the gold standard to detect SARS-CoV-2, however, its capacity is limited. We evaluated an automated antigen detection (AAD) test, Elecsys SARS-CoV-2 Antigen (Roche, Germany), for detecting SARS-CoV-2. Results: We compared the limit of detection (LOD) between AAD, rapid antigen detection (RAD) test, SARS-CoV-2 Rapid Antigen Test (SD Biosensor, Korea), and in-house RT-PCR test. LOD results showed that the AAD test was 100 fold more sensitive than the RAD test, while the sensitivity of the AAD test was comparable to the RT-PCR test. The AAD test detected between 85.7% and 88.6% of RT-PCR-positive specimens collected from COVID-19 patients, false negative results were observed for specimens with Ct values >30. Conclusions: Although clinical sensitivity for the AAD test was not superior or comparable to the RT-PCR test in the present study, the AAD test may be an alternative to RT-PCR in terms of turn-around time and throughput.

Aim: Currently, there is lack of data regarding rapid antigen detection (RAD) kits to detect SARS-CoV-2 B.1.617.2 virus. Objective: The purpose of this evaluation is to assess analytical sensitivity of 12 RAD kits against SARS-CoV-2 B.1.617.2. Study design: Analytical sensitivity was determined by limit of detection (LOD). A serial tenfold dilution set from a respiratory specimen collected from a COVID-19 patient infected by SARS-CoV-2 B.1.617.2 was used. RT-PCR was used as a reference method. Results: The LOD results showed that 11 and one RAD kits were 100- and 1000-fold less sensitive than RT-PCR respectively. Conclusion: The results showed that the RAD kits evaluated in this study may be used for first-line screening of the SARS-CoV-2 B.1.617.2 variant.