For professional in-vitro diagnostic use only
-CE-IVD marked set of reagents to detect SARS-CoV-2
-Positive control to validate assay included
-Internal control to confirm extraction / inhibition included
-Individual amplification of the viral and Human Targets in a single reaction
-Multi Platform capability
Description: NZYTech SARS-CoV-2 One-Step RT-PCR Kit (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common real-time PCR platforms. By using NZYTech SARS-CoV-2 One-Step RT-PCR Kit (IVD), RNA isolated and purified in association with a CE IVD extraction system is retrotranscribed (RT) to cDNA and subsequently amplified by PCR, in a single reaction, using two highly specific primers/probe sets exploiting the so-called TaqMan® principle. When the RNA extracted from respiratory samples is collected from an infected patient, a TaqMan® probe specifically binds to a conserved region of the SARS-CoV-2 RdRp gene circumscribed by an equally specific pair of primers. An additional primers/probe set acts as an internal control to detect a nucleic acid sequence of the human ribonuclease P [RNase P gene (RP)], which allows confirming the efficacy of the extraction process from human derived biological material. In addition, this internal control allows to demonstrate that no reaction inhibition has occurred by PCR inhibitors potencially present in the clinical samples. The two probes are differently labelled, with FAM™ and JOE™ reporter dyes, to allow identifying the individual amplification of the viral and human targets in a single reaction, respectively. Furthermore, they are provided in optimized concentrations to make sure amplification of human mRNA, even when present at very high concentrations, does not limit the efficiency of the SARS-CoV-2 primers/probe set. NZYTech SARS-CoV-2 One-Step RTPCR Kit (IVD) includes a Positive control that allows controlling the performance of RT-PCR reactions.
NZYTech SARS-CoV-2 One-Step RT-PCR Kit (IVD) was validated for the following Real Time PCR Systems: Applied Biosystem® 7500, Applied Biosystem® StepOnePlus and Bio-Rad® CFX96™.
-NZYSpeedy One-step RT-qPCR MasterMix
-SARS-CoV-2/RP primers/probe Mix
-SARS-CoV-2/RP Positive Control (1 x 104 copies/μL)
-RNase/DNase free Water
Storage conditions: -30 °C to -15ºC
Shipping conditions: Shipped with dry ice