NEW YORK – The US Food and Drug Administration last week granted DxLab Emergency Use Authorization for its molecular DxLab COVID-19 test.
The RT-LAMP test, which uses anterior nasal swab samples, is performed using the Somerville, Massachusetts-based company's DxHub instrument. The qualitative assay is intended for patients suspected of having COVID-19 by their healthcare provider or for people without symptoms or epidemiological reasons to suspect they have COVID-19 when they are tested twice over three days with at least 24 hours between tests, the FDA said.
The test is authorized for use in CLIA-certified labs or at the point of care in CLIA-waived settings.
The DxHub instrument is a tabletop device with eight separate test bays that allow up to eight samples to be processed and returns results in 25 minutes or less, according to the firm's website.