CDC’s latest emergency use authorization for influenza SARS-CoV-2 assay validates Quantabio’s ability to multiplex up to five targets with high efficiency, sensitivity and specificity
BEVERLY, Mass. – July 16, 2020 – Quantabio, 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 new emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. The Flu SC2 Assay is a real-time, reverse transcription quantitative PCR (RT-qPCR) test that aids in the detection and differentiation of RNA from the similar SARS-CoV-2, influenza A and/or influenza B viruses. Qualified high-complexity, CLIA-certified laboratories are now advised to use the UltraPlex 1-Step ToughMix, as one of two validated master mixes, to ensure robust and reliable performance of multiplexed RNA detection assays that may have a wide range of inhibitory starting materials.
The Flu SC2 Multiplex Assay protocol is the latest in a series of CDC EUA protocols to recommend Quantabio reagents for respiratory disease detection and differentiation. Since 2013, Quantabio products have been cited in testing protocols for H7N9 Avian Influenza, Polio and COVID-19. Most recently, the UltraPlex 1-Step ToughMix was also recognized in the amended CDC COVID-19 EUA as part of an effective heat treatment alternative for public health laboratories facing RNA extraction reagent supply shortages. The RT-qPCR kit has been demonstrated to provide high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates.
“Since symptoms of SARS-CoV-2 and influenza infections can be similar, testing protocols must be highly sensitive to differentiate the type of virus, and very robust and reliable to overcome potential inhibitors within the samples,” said Heather Meehan, PhD, Vice President and Head of Quantabio. “Quantabio is committed to supporting the adoption of the use of the UltraPlex 1-Step ToughMix in the CDC protocol by the stakeholders within the relevant government agencies.”
UltraPlex 1-Step ToughMix is a ready-to-use, one-step, 4X concentrated RT-qPCR master mix 1-step that uses probe-based detection methods. The kit contains all required components 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 www.quantabio.com/ultraplex-1-step-toughmix.
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 www.quantabio.com.
Quantabio products are intended for molecular biology applications. This product is not intended for the diagnosis, prevention or treatment of a disease.