Vela Diagnostics to Offer Manual ViroKey SARS-CoV-2 RT-PCR Test

Vela Diagnostics (Singapore) plans to offer its manual ViroKey SARS-CoV-2 RT-PCR Test after its validation is completed and is currently working with the US Food and Drug Administration (FDA) for securing Emergency Use Authorization (EUA) for the test. Vela is a provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency.

Vela’s ViroKey SARS-CoV-2 RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals meeting CDC SARS-CoV-2 clinical criteria (e.g., clinical signs and symptoms associated with SARS-CoV-2 infection) in conjunction with CDC SARS-CoV-2 epidemiological criteria (e.g., history of residence in, or travel to a geographic region with active SARS-CoV-2 transmission at the time of travel, or other epidemiologic criteria for which SARS-CoV-2 testing may be indicated).

The automated workflow is intended to be used on the Sentosa SX101 with the Sentosa SX Virus Total Nucleic Acid Kit v2.0 in conjunction with the Sentosa SA201 instrument for high-throughput RT-PCR. The assay also fits into a manual workflow for laboratories with existing Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument.

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