The US Food and Drug Administration has granted Emergency Use Authorization (EUA) to TaqPath COVID-19 Combo Kit to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19, announced Thermo Fisher Scientific.
The diagnostic assay facilitates qualitative detection of SARS-CoV-2 nucleic acid in the nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens from COVID-19 suspected individuals by their healthcare provider.
The test can be run on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument or other authorized instruments, according to the authorization documents.
The TaqPath kit contains three primers and probe sets specific to SARSCoV-2 genomic regions encoding Orf-1ab, N protein, and S protein as well as primers and probes for bacteriophage MS2, and an MS2 phage control reagent. The kit also has an RNA positive control that contains the SARS-CoV-2 genomic regions targeted by the kit.
This is the second commercially distributed test to receive a EUA, after Roche’s swab sample test for SARSCOV-2, during the COVID-19 outbreak.