The U.S. Food and Drug Administration gave Fairfield-based Vela Diagnostics an Emergency Use Authorization for its ViroKey COVID-19 RT-PCR Test v2.0.
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 kit now runs with the KingFisher FLEX, to decrease turnaround time and increase sample throughput. The workflow also maintains VELA’s proprietary SA201 Reporter as part of its workflow, providing pathologists an accurate and clinically relevant report.
Vela Diagnostics is now also offering a Hamilton Microlab STAR option, which has a throughput of 376 samples per run.
Workflow test data for both options has been submitted to FDA and acknowledged as a supplement to the ViroKey SARS-CoV-2 RT-PCR Test v2.0 EUA. While the modified test data has not been reviewed by FDA and product changes are in queue for review, commercial availability for the U.S. market is provided through FDA’s EUA distribution policies.
“The Hamilton Microlab STAR workflow option comes at a time when many of our customers are still ramping up COVID-19 testing. This high-throughput workflow will allow laboratories to process substantially more samples per day, with less hands-on time and reduced labor cost,” said Steven Wallace, executive vice president of Vela.