Quantabio kit added to Yale FDA EUA SalivaDirect Platform

July 19, 2021

Quantabio, a provider 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. 

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.  

Visit Quantabio for more