Amended CDC emergency use authorization recognizes UltraPlex formulation in an effective heat treatment alternative for RNA extraction

BEVERLY, Mass. – July 1, 2020Quantabio, a leading provider of robust DNA and RNA amplification reagents for the most demanding molecular testing and life science research applications, today announced that its UltraPlex 1-Step ToughMix was recognized as part of the expanded emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) COVID-19 testing protocol. Public health laboratories facing RNA extraction reagent supply shortages are now advised to use the amended protocol, which includes the one-step, reverse transcription and real-time quantitative PCR (RT-qPCR) kit that provides high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates.

The CDC first added Quantabio’s UltraPlex 1-Step ToughMix and qScript XLT 1-Step RT-qPCR ToughMix to its protocol for the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel in April 2020. Due to the global shortage of nucleic acid extraction reagents, CDC recently amended the EUA protocol to include a heat treatment methodology, using UltraPlex 1-Step ToughMix, as a viable alternative to RNA extraction. The UltraPlex 1-Step ToughMix is a ready-to-use, single-component, 4X concentrated master mix solution that delivers robust and reliable performance of highly multiplexed RNA detection assays with a wide range of inhibitory starting materials while maintaining very high sensitivity.

“Over the past seven years, Quantabio has actively supported development of testing protocols for influenza, polio and other infectious diseases,” said Heather Meehan, PhD, Vice President and Head of Quantabio. “Our expertise in enzyme development and large-scale production competencies have now been applied to COVID-19 testing solutions for commercial testing providers, state public health laboratories and molecular diagnostic tools companies in the US and around the world. The UltraPlex 1-Step ToughMix overcomes common PCR inhibitors, delivers superior performance and enables laboratories to continue testing for COVID-19 despite the global reagent supply issues.”

The UltraPlex 1-Step ToughMix Kit contains all required components for RT-qPCR except RNA template and probe and is compatible with all dual-labeled probe chemistries. The simple workflow enables scientists to conduct first-strand cDNA synthesis and PCR amplification in the same, closed tube. For more information, please visit

About Quantabio
Quantabio is a leading provider of advanced DNA and RNA amplification reagents for the most demanding molecular testing applications in applied, translational and life science research. The Quantabio team leverages decades of experience in developing pioneering amplification technologies to deliver cutting-edge products to researchers focused on critical PCR, qPCR and Next-Generation Sequencing (NGS) based applications. Based in Beverly, Mass., Quantabio offers a growing portfolio of products through its international sales operations, as well as a global network of distributors and commercial service providers. For more information, please visit

Quantabio products are intended for molecular biology applications. This product is not intended for the diagnosis, prevention or treatment of a disease.


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