June 22, 2021 – Thermo Fisher Scientific (Waltham, MA) announced the launch of a new CE-IVD-marked COVID-19 test.
The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher’s menu of highly accurate tests that detect active SARS-CoV-2 infections.
Thermo Fisher Scientific says the kit uses an advanced assay design which compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate.
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 test assesses raw saliva directly with a turnaround time of two hours to enable widespread, high-frequency testing.
The first generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use a different assay design, respectively, received initial CE-IVD certification and Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in March 2020.