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Thermo Fisher Scientific has announced the launch of a new test for COVID-19 with the CE-IVD mark. The TaqPath COVID-19 Fast PCR Combo Kit 2.0 expands Thermo Fisher's menu of high-precision tests that detect active SARS-CoV-2 infections.
The kit uses an advanced assay design that compensates for current and emerging variants by using eight total targets in three genomic regions of the virus. This approach helps ensure that the test provides accurate results even when the virus that causes COVID-19 continues to mutate.
"Variants of COVID-19 may be more communicable and potentially affect the efficacy of diagnostics, vaccines, and therapies, threatening to reverse the progress made last year," explained Manoj Gandhi , MD, Ph.D., Thermo Fisher's Senior Medical Director for Genetic Sciences . "We are working to empower our clients to prepare for the next stage of the pandemic by future proofing our test design against probable mutations and offering them continued confidence in their results."
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 test assesses raw saliva directly with a response time of two hours to allow generalized high-frequency testing. The TaqPath COVID-19 CE-IVD RT PCR First Generation Kit and the TaqPath COVID-19 Combo Kit, using a different assay design, respectively, received initial CE-IVD certification and emergency use authorization from the Administration. Food and Drug Administration (FDA) in March 2020.
