Thermo Fisher Scientific has obtained 510(k) clearance from the FDA for its Applied BioSystems TaqPath COVID-19 Diagnostic PCR Kit. Previously authorized for emergency use, this clearance allows clinical and public health laboratories to adopt an in vitro diagnostic (IVD) workflow. The kit detects RNA from SARS-CoV-2 using nasopharyngeal and anterior nasal swabs and employs a multi-gene target design for accurate diagnosis, even as new variants emerge.
Key features include fast results within three hours and compatibility with standard PCR instruments. Designed for use in reference labs, public health labs, and academic medical centers, the kit builds on the proven performance of its EUA predecessor, which tested over a billion samples during the COVID-19 pandemic.
The kit was previously authorized for emergency use, and this clearance allows clinical and public health laboratories to adopt an in vitro diagnostic (IVD) workflow. The kit detects RNA from SARS-CoV-2 using nasopharyngeal and anterior nasal swabs and employs a multi-gene target design for accurate diagnosis, even as new variants emerge.
