FDA Grants EUA to Helix Diagnostics SARS nCOV-2019 Multiplexed Assay Test
The FDA has granted Emergency Use Authorization (EUA) to Helix Diagnostics’ SARS nCOV-2019 multiplexed assay test.
The test is authorized for qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples. The samples can either be collected by a healthcare provider or self-collected under the supervision of a healthcare provider.
The FDA has authorized the collection of samples from individuals who are without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
Under the EUA, the agency has limited analysis of the test samples to Helix Diagnostics’ laboratory in Waterford, Mich.