COVID-19 Real-Time PCR assay EUA (USA)


In Stock & Ready to Ship

Product Features

  • • Rapid detection and exclusive to the COVID-19 strain
  • • Does not detect other related coronavirus strains
  • • High priming efficiency
  • • Accurate controls to confirm extraction, and assay validity
  • • Lyophilised components for ambient shipping
  • • Highly specific detection profile

This test has been authorized by FDA under an EUA for use by authorized laboratories.


The Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

*FDA clinical study. See Instructions for Use for additional clinical data.

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Kit contents

• 3 x lyophilised OneStep Master Mix (50 reactions per glass ampule)

• 1 x lyophilised ROX (BROWN)

• 4 x Resuspension buffer (BLUE)