SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N Genes, CE-IVD (MD04831)

Activity: Target: Virus RNA dependent RNA polymerase (RdRp) gene/Nucleocapsid phosphoprotein (N) gene and Human RNase P (RP) gene
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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. 


-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: -30°C to -15°C

Shipping conditions: Shipped with dry ice



SARS-CoV-2 Variants
PT Instrucoes de utilizacao
FR Mode d emploi
ES Instrucciones de Uso
EN Instructions for Use
DE Gebraunchsanweisung
Declaration of Conformity
Certificate of Analysis ZN021B
Certificate of Analysis ZN021A
Certificate of Analysis ZN012
Certificate of Analysis ZN011B
Certificate of Analysis ZN011
Certificate of Analysis NM122
Certificate of Analysis NM121
Certificate of Analysis NM103
Certificate of Analysis MD0483ZN062D
Certificate of Analysis MD0483ZN062C
Certificate of Analysis MD0483ZN062B
Certificate of Analysis MD0483ZN062A
Certificate of Analysis MD0483ZN061
Certificate of Analysis MD0483ZN024
Certificate of Analysis MD0483ZN023B
Certificate of Analysis MD0483ZN023A
Certificate of Analysis MD0483ZN022B
Certificate of Analysis MD04831ZN082A
Certificate of Analysis MD04831ZN072A
Certificate of Analysis MD04831ZN071

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