US-based Thermo Fisher Scientific has secured CE-IVD mark approval for next-generation TaqPath Covid-19 RNase P 2.0 assay kit.
TaqPath Covid-19 RNase P 2.0 kit is a newly designed test, which delivers precise results by compensating for current and future Covid-19 viral mutations.
It has been redesigned for the detection of active SARS-CoV-2 infections by identifying the presence of any one of eight gene targets from the virus.
By surveying across various genes, the test holds the potential to deliver accurate results even as mutations shift the genes they express, said the company.
Thermo Fisher Scientific genetic testing solutions senior medical director Manoj Gandhi said: “SARS-CoV-2 is continuing to mutate, and this assay is the latest in our efforts to make sure our tests are future proofed against those variants.
“With this product, we are offering customers the next generation of our COVID-19 diagnostic test that has inbuilt checks and balances in the face of emerging variants.”
The newly designed assay is used by the TaqPath COVID-19 RNase P 2.0 kit for the assessment of nasopharyngeal and nasal swab samples to identify Covid-19 cases. It has a turnaround time of about three hours
Since March last year, the first-generation TaqPath Covid-19 CE-IVD RT PCR Kit has been available for testing the people.
In August this year, Thermo Fisher secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 assays.
