Vela Diagnostics receives CE-IVD approval for automated Flu A/B & RSV Extension Kit

The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit is now CE certified.

Singapore, Mar 17 2020 – Vela Diagnostics announced today that its ViroKey™ Flu A/B & RSV RT-PCR Extension Kit (for use only with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0), has received the CE mark for in vitro diagnostic use.

The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit detects Influenza A, Influenza B and RSV by targeting the matrix protein gene in the RNA of the respective viruses. The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 RNA—the ORF1a and N genes.

The tests are optimized on a workflow consisting of the Sentosa™ SX101 instrument for automated sample extraction and PCR setup, in conjunction with the Sentosa™ SA201 instrument. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 46 samples (and two controls) can be tested—to detect up to four viruses—in a single run. The PCR is set up as two separate reactions; one to detect SARS-CoV-2, and the other for the Flu A/B and RSV triplex. This prevents masking of low positive results, resulting in higher sensitivity of detection.

“The flu season and the recent appearance of a new SARS-CoV-2 variant makes pandemic management all the more challenging, especially when these viral infections cause similar symptoms in patients. With the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit, we can distinguish across the four viruses in patients with flu-like symptoms, thus enabling clinicians to prescribe the appropriate treatment protocol at the soonest,” said Managing Director, Andreas Goertz.

The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 received the CE mark in July 2020.

About Vela Diagnostics

Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.

All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

Go back