LAUSR

A 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, reverse transcription polymerase chain reaction (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 < 30. The mariPOC SARS‐CoV‐2 test detected two of six 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.