Clinical evaluation of an automated, rapid mariPOC antigen test in screening of symptomatics and asymptomatics for SARS-CoV-2 infection
: Gunell Marianne, Rantasärkkä Kaisa, Arjonen Rita, Sanden Antti, Vuorinen Tytti
Publisher: WILEY
: 2023
: Journal of Medical Virology
: JOURNAL OF MEDICAL VIROLOGY
: J MED VIROL
: 7
: 0146-6615
DOI: https://doi.org/10.1002/jmv.28189
: https://research.utu.fi/converis/portal/detail/Publication/176814395
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 C-t < 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 C-t 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.
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