Clinical validation of two immunochromatographic SARS-CoV-2 antigen tests in near hospital facilities

Rapid antigen tests to detect SARS-CoV-2 virus need to be validated. The purpose of clinical validation is to place the test into the everyday working process in health care institutions.

The clinical validation of Alltest Covid19 antigen test (Alltest, China) and Vivadiag Pro SARS- CoV-2 antigen tests (Vivacheck, China) started in four Slovenian health care institutions in December as a point-of-care test. Institutions compared the results of antigen tests to Seegene Allplex™ 2019-nCoV rt-PCR assay (SeeGene, South Korea) and Cobas 6800 SARS CoV-2 rt-PCR (Roche, USA).

Sensitivity (90.6%, 95% CI = 84.94%-94.36%) and specificity (100%, 95% CI = 99.41%-100%) of Vivadiag Pro SARS CoV-2 Ag test were observed. While validating Alltest Covid19 Ag assay we got similar results (sensitivity 94.37%, 95% CI = 89.20% - 97.54%), specificity 100% (95% CI = 98.83% - 100%).

Vivadiag Pro SARS CoV-2 Ag test and Alltest Covid19 test proved to be a good screening tool to detect SARS-CoV-2. The accurate information about the patient's status was available almost immediately and there was no need to wait for rt-PCR results. We could prevent further spread of the SARS-CoV-2 in primary care and hospital settings.