New SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N Genes, CE-IVD -- MEDICA - World Forum for Medicine

16/09/2021

NZYTech Lda.

New SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N Genes, CE-IVD

For professional in-vitro diagnostic use only

Triple target assay (SARS-CoV-2, RdRp and N genes, and human RP gene)
Positive control to validate assay included
Internal control to confirm extraction / inhibition included

High Sensitivity: Early virus detection and diagnosis, detects as low as 150 copies of viral RNA /mL (LoD) sample (equivalent to 3 copies per reaction)
Precision: Coefficient of variation (CV) < 2%, allowing reproducible test results
High Throughput: Up to 94 clinical samples (96-well plate); up to 382 clinical samples (384-well plate)
High Specificity: Proven by in silico analysis as well as wet lab testing
Flexibility: Assay validated on widely used qPCR instruments including ABI® 7500, ABI® StepOnePlus™, ABI® QuantStudio™ 6, Bio-Rad® CFX96, Qiagen® Rotor-Gene Q, Roche® LC 480 II
Fast Time: < 1h30min from nucleic acid extraction to results.
Minimal Sample Input: As low as 2 μL sample needed

 

Description:   NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common realtime PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection. By using NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N genes (IVD), RNA isolated and purified with a CE IVD extraction system is retrotranscribed (RT) to cDNA and subsequently amplified by PCR, in a single reaction, using three highly specific primer/probe sets exploiting the so-called TaqMan® principle. During this process, the probes specifically anneal to two regions of the SARS-CoV-2 genome, namely RdRp (within the Orf1ab polyprotein gene) and N genes, in case the sample was extracted from an infected patient. An additional primers/probe set acts as an endogenous internal control to detect nucleic acids of the human ribonuclease P [RNase P gene (RP)], assessing sample quality. In addition, this internal control demonstrates that no reaction inhibition has occurred by PCR inhibitors potentially present in the clinical/environmental samples. To allow identifying the amplification of the three specific targets in a single reaction, SARS-CoV-2 and human RNase P specific probes are differently labelled, with FAM™ and JOE™ reporter dyes, respectively. Note that this panel contains a duplex assay in the same optical FAM™ channel to report an additive performance of the two PCR assays for SARS-CoV-2 detection. In addition, 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 sets. 

 

Components:
-NZYSupreme One-step RT-qPCR Master Mix
-SARS-CoV-2(RdRp & N genes)/RP primer/probe Mix (FAM™ and JOE™ labelled)
-SARS-CoV-2(RdRp & N genes)/RP Positive Control (1 x 104 copies/μL)
-RNase/DNase free Water

Storage conditions: -20 °C

Shipping conditions: Shipped with dry ice

Exhibitor Data Sheet