ViroKey SARS-CoV-2 RT-PCR Test receives the CE mark for in vitro diagnostic test for COVD-19.- Vela Diagnostics

Vela Diagnostics announced that the manual version of the ViroKey SARS-CoV-2 RT-PCR Test has received the CE mark for in vitro diagnostic use. The test detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers.

The ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.

Vela Diagnostics has also developed an automated version of the test which is slated for CE-IVD registration in April 2020. The automated ViroKey SARS-CoV-2 RT-PCR Test is optimized for a workflow consisting of the Sentosa SX101 instrument, in conjunction with the Sentosa SA201 instrument or the ABI 7500 Fast Dx.