Ahead of emergency use authorization (EUA) and in accordance with the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will offer the manual ViroKey SARS-CoV-2 RT-PCR test when validation is completed. The company expects validation to be completed in early April 2020. The test is currently available for preorders.
The ViroKey SARS-CoV-2 RT-PCR test detects and differentiates the SARS-CoV-2 virus, the cause of covid-19, from other respiratory pathogens such as influenza.
The manual assay was developed to facilitate quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instruments. The research use only test is configured for an automated workflow consisting of the Sentosa SX101 instrument, in conjunction with the ABI 7500 Fast Dx or the Sentosa SA201 instruments. The manual ViroKey SARS-CoV-2 RT-PCR test is also on track to receive the CE mark.
For more information, visit Vela Diagnostics.
