Empirical EUA Statement
The QuantiTASE Plus One Step RT-qPCR SARs-CoV-2 assay kit is available for In Vitro Diagnostic (IVD) use in accordance with the May 11 2020 FDA guidance document titled: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
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The QuantiTASE Kit from Empirical Bioscience is an RT-qPCR universal kit that contains the reagents and master mixes necessary for accurate detection of DNA or RNA. The reagents have been optimized for qPCR or RT-qPCR applications for use with both intercalating dye and probe-based detection methods.
The Kit contains Empirical RTScriptTM (M-MLV) Reverse Transcriptase Enzyme Mix and 4X InhibiTaq Plus HotStart qPCR MasterMix and 100mM DTT solution.
InhibiTaq qPCR MasterMix is a proprietary chemically modified HotStart (2 minute activation) Taq polymerase and novel buffer system which has been developed to tolerate inhibitors commonly found in many samples. It is designed to reduce the amount of sample processing required for reliable qPCR analysis and can be used for amplification from inhibitor-rich samples such as urine, saliva, cerebral spinal fluid (CSF), whole blood, serum, plasma, feces and plants samples.
The qPCR MasterMix contains a passive ROX reference dye that enables it to be used on a wide variety of instruments. This means that on most platforms no additional components are required to ensure compatibility. A supplemental ROX solution is also included for use, should it be required. The enzymes and buffer system has been optimized to support both one-step and two-step RT-qPCR protocols.