Friday, 29 May 2020

Promega amplification reagent now in CDC’s COVID-19 EUA diagnostic panel

03 April 2020 | News

The assay protocol is used by hundreds of public health labs and clinical testing labs in the United States

Promega Corporation’s GoTaq® Probe 1-Step RT-qPCR System is now in a Centers for Disease Control and Prevention COVID-19 diagnostic protocol for emergency use.

The Promega tool is an approved master mix option for the CDC’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel that is available through the CDC’s Emergency Use Authorization (EUA).

In a letter dated March 30, 2020, the FDA granted approval of an amendment to the CDC’s diagnostic COVID-19 assay that includes acknowledgement that Promega master mix is an approved amplification reagent for laboratories using the CDC’s assay.

The assay protocol is used by hundreds of public health labs and clinical testing labs in the United States and is referenced by thousands of labs around the world.

The GoTaq® Probe 1-Step RT-qPCR System is a ready-to-use master mix of optimized components for robust RT-qPCR using hydrolysis probes. Promega supplies automation, sample extraction and diagnostic reagents around the world, and began scaling up manufacturing in January to address unprecedented demand for COVID-19 related tools. Promega reagents are also currently incorporated in 15 COVID-19 diagnostic tests produced by other global diagnostic manufacturers.

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