Quantabio’s UltraPlex 1-Step ToughMix Added to SalivaDirect Emergency Use Authorization Protocol

Authorized CLIA-certified laboratories running the SalivaDirect protocol can now use the UltraPlex 1-Step ToughMix, which was designed to increase sensitivity and improve assay performance, especially when dealing with saliva samples that may contain a low copy number of RNA virus.

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Monday, July 12, 2021
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Science, Biotechnology, Research, Health, FDA, Medical devices, Infectious diseases, Genetics, Natural sciences, Laboratory techniques, Chemistry, Physical sciences, Molecular biology, Polymerase chain reaction, Biotechnology, Amplifiers, Real-time polymerase chain reaction, Assay, Reverse transcription polymerase chain reaction
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United States, Massachusetts, BEVERLY
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QUANTABIO
Summary
Key Points: 
  • Authorized CLIA-certified laboratories running the SalivaDirect protocol can now use the UltraPlex 1-Step ToughMix, which was designed to increase sensitivity and improve assay performance, especially when dealing with saliva samples that may contain a low copy number of RNA virus.
  • The addition of the Quantabio UltraPlex 1-Step ToughMix enhances the protocol by enabling scientists to overcome common PCR inhibitors and quantify RNA viruses with high efficiency, sensitivity and specificity using as little as 1 pg of starting material.
  • Being added to the SalivaDirect EUA protocol is another strong validation of the versatility of our UltraPlex 1-Step ToughMix, said Heather Meehan, PhD, Vice President and Head of Quantabio.
  • UltraPlex 1-Step ToughMix is a ready-to-use, one-step, 4X concentrated RT-qPCR master mix that uses probe-based detection methods for real-time PCR.


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 validated and added to the emergency use authorization (EUA) protocol for the Yale School of Public Health’s SalivaDirect™ Platform as of June 3, 2021. Authorized CLIA-certified laboratories running the SalivaDirect protocol can now use the UltraPlex 1-Step ToughMix, which was designed to increase sensitivity and improve assay performance, especially when dealing with saliva samples that may contain a low copy number of RNA virus.

Originally granted EUA status from the US Food and Drug Administration in August 2020, the SalivaDirect protocol offers a streamlined, open-source and more cost-effective method for mass testing of symptomatic and asymptomatic individuals for the SARS-CoV-2 infection. The real-time reverse transcription polymerase chain reaction (RT-PCR) test eliminates the extraction and purification steps for isolating RNA viruses from saliva samples. The addition of the Quantabio UltraPlex 1-Step ToughMix enhances the protocol by enabling scientists to overcome common PCR inhibitors and quantify RNA viruses with high efficiency, sensitivity and specificity using as little as 1 pg of starting material. With the ability to multiplex up to five targets, the one-step master mix also enables scientists to detect emerging variants as the SARS-CoV-2 virus continues to evolve. The same kit 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 Yale School of Public Health is committed to increasing the availability of inexpensive, simple and scalable COVID-19 testing options. Our SalivaDirect protocol replaces the often difficult and uncomfortable nasopharyngeal swabs and offers a much more cost-effective methodology for mass testing,” said Anne Wyllie, PhD, Research Scientist at Yale School of Public Health.

“Being added to the SalivaDirect EUA protocol is another strong validation of the versatility of our UltraPlex 1-Step ToughMix,” said Heather Meehan, PhD, Vice President and Head of Quantabio. “Quantabio is dedicated to supporting the thousands of labs across the country that are using our products on the frontlines in this fight against the coronavirus. With the robust multiplex performance, simple workflow and low price per reaction, customers can rapidly scale testing capacity while decreasing costs and reducing the strain on the supply chain.”

UltraPlex 1-Step ToughMix is a ready-to-use, one-step, 4X concentrated RT-qPCR master mix that uses probe-based detection methods for real-time PCR. 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.

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