Clinical evaluation of an automated, rapid mariPOC® antigen test in screening of symptomatics and asymptomatics for SARS-CoV-2 infections

Abstract

AbstractA novel automated mariPOC® SARS-CoV-2 antigen test was evaluated in a Health care center laboratory among symptomatic and asymptomatic individuals seeking SARS-CoV-2 testing. According to the national testing strategy, RT-PCR was used as a reference method. A total of 962 subjects were included in this study, 4.8% (46/962) of their samples were SARS-CoV-2 RT-PCR positive, and 87% (40/46) of these were from symptomatics. Among the symptomatics, the overall sensitivity of the mariPOC® SARS-CoV-2 test was 82.5% (33/40), though the sensitivity increased to 97.1% (33/34) in samples with a Ct value <30. The mariPOC® SARS-CoV-2 test detected 2/6 PCR positive samples among the asymptomatics, four cases that remained antigen test negative had Ct values between 28 and 36. The specificity of the mariPOC® SARS-CoV-2 test was 100% (916/916). The evaluation showed that the mariPOC® SARS-CoV-2 rapid antigen test is very sensitive and specific for the detection of individuals who most probably are contagious.