Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

Tests that are intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 at the point of care by trained health professionals (nasopharyngeal and oropharyngeal swabs), by lay person self-testing (nasal swab), and by qualitative in vitro nucleic acid amplification assay (RT-PCR) by trained professionals.