Vela Diagnostics has announced that its ViroKey SARS-CoV-2 RT-PCR Test v2.0 now has the additional capability to be used for pooling, using a three-in-one media pooling strategy.
This FDA EUA authorized indication is authorized for use in laboratories certified under CLIA to perform high complexity tests, for the qualitative detection of RNA from the SARS-CoV-2 in pooled samples containing aliquots of transport media from up to 3 individual human anterior nasal swab specimens from not only individuals who are symptomatic, but also those who are asymptomatic and are participation in serial testing programs.
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 was developed by Vela Diagnostics for the detection of SARS-CoV-2, the virus behind the global pandemic of COVID-19. With at least three workflows available, laboratories can leverage that flexibility, depending on what the throughput of their laboratory is.
The media pooling strategy can be done by combining sample media of up to 3 patients to be tested as one sample, thereby only using resources needed for a single test. In a population with low positivity rate, this method increases testing throughput, improves laboratory efficiency, and reduces overall cost of testing.
“At Vela Diagnostics, we aim to provide solutions that work in real situations. With the FDA encouraging the development of tests for pooled samples, we have added the ability to aid in the increase of testing throughput,” said Sam Dajani, Chairman and CEO of Vela Diagnostics.
“Laboratories can now leverage this capability to cope with the sudden surges that we have all experienced in waves throughout this pandemic,” said Scott Cassidy, Director of Business Development. “We believe this is an important capability in the COVID-19 pandemic, where incidences and levels of testing can fluctuate at any time.”
The ViroKey SARS-CoV-2 RT-PCR Test v2.0 received its EUA in September 2020, has CE mark in EU, and is also approved by Australian TGA and multiple regulatory authorities globally.