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The Centers for Disease Control and Prevention (CDC) has added Promega’s amplification reagent GoTaq Probe 1-Step RT-qPCR System to its coronavirus (Covid-19) diagnostic protocol for emergency use.
Promega’s system is a ready-to-use master mix of optimised components for RT-qPCR using hydrolysis probes.
It is designed for sensitive detection and quantification of a broad range of DNA or RNA targets in the presence of a wide range of PCR inhibitors.
The US Food and Drug Administration (FDA) recently approved an amendment to the CDC’s diagnostic Covid-19 assay that includes an acknowledgement that GoTaq is an approved amplification reagent for laboratories that use the CDC’s assay.
CDC’s assay protocol is used by several public health labs and clinical testing labs across the US and is referenced by labs globally.
Promega Clinical Diagnostics director Heather Tomlinson said: “Thanks to the CDC acting quickly to make product additions to their protocol, labs now have one more CDC-approved master mix when performing the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
“The Promega GoTaq Probe 1-Step RT-qPCR System expands the testing capacity in the US by being another option for labs to use for the amplification process in the CDC’s testing protocol.”
The company supplies automation, sample extraction and diagnostic reagents across the world. Promega accelerated the production in January to address unprecedented demand for Covid-19-related tools.
Currently, Promega reagents are incorporated in 15 Covid-19 diagnostic tests developed by different global diagnostic manufacturers.