Summary: Thermo Fisher Scientific’s TaqPath COVID-19 Diagnostic PCR Kit, now FDA 510(k) cleared, enables clinical and public health laboratories to adopt a validated in vitro diagnostic workflow for SARS-CoV-2 detection.

Takeaways:

  1. Enhanced Diagnostic Confidence: The multi-gene target design (ORF1ab, N gene, S gene) ensures reliable detection of SARS-CoV-2, even as new mutations emerge, supporting accurate diagnoses.
  2. Proven Performance: Built on the same chemistry as the EUA kit used for over one billion tests during the pandemic, the 510(k) clearance validates its reliability for widespread clinical use.
  3. Rapid Results: The kit delivers real-time PCR diagnostic results in as fast as three hours, enabling care teams to make timely and informed treatment decisions.

Thermo Fisher Scientific received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Applied BioSystems TaqPath COVID-19 Diagnostic PCR Kit. First introduced as an Emergency Use Authorized (EUA) test, the 510(k) clearance allows clinical and public health laboratories to convert to an in vitro diagnostic (IVD) workflow.  

About the TaqPath COVID-19 Diagnostic PCR Kit

Thermo Fisher Scientific is committed to its clinical customers in driving continuous innovation. The 510(k) cleared TaqPath COVID-19 Diagnostic PCR Kit is built from the same chemistry as the EUA kit that was used to test over one billion patient samples during the height of the COVID-19 pandemic.  

The kit is intended for use with 2 types of patient samples, nasopharyngeal and anterior nasal swabs, and it includes the necessary assays and controls for the real-time PCR detection of RNA from SARS-CoV-2 emerging virus. As new mutations continue to emerge, the TaqPath COVID-19 Diagnostic PCR Kit multi-gene target design (ORF1ab, N gene S gene) provides greater confidence in results to support an accurate diagnosis.  

Key Applications:

  • Reference/Clinical Laboratories  
  • Public Health Laboratories  
  • Academic Medical Centers  

Features/Benefits

  • All in one solution: The TaqPath COVID-19 Diagnostic PCR Kit comes in a combo kit that includes: 
    • TaqPath COVID-19 Diagnostic PCR Assay Kit 
    • TaqPath COVID19 Diagnostic PCR Control 
    • TaqPath COVID19 Diagnostic PCR Control Dilution Buffer 
  • Proven performance + reliability: Building on the emergency-use-authorized COVID-19 test, the 510(k) cleared kit is validated and available for use on common PCR instruments in the United States.  

Real-time diagnostic insights: Results are delivered in as fast as 3 hours, empowering care teams to quickly determine the best course of treatment