NEW YORK ─ Vela Diagnostics said on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its ViroKey SARS-CoV-2 RT-PCR Test v2.0.
The automated probe-based RT-PCR test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs and is optimized for a workflow consisting of Vela Diagnostics' Sentosa SX101 and Sentosa SA201 instruments. The test enables high-throughput testing of up to 46 samples in a single run with reduced hands-on time, Vela said.