COVID-19 & Flu A/B Multiplex One-Step RT-qPCR Kit, CE-IVD (MD04851)

Activity: Target: SARS-CoV-2 RdRp and N genes, Influenza A M1 gene, Influenza B NS2 gene and human RP gene
Refrigerated package

999,00

96 Determinations

999,00

For professional in-vitro diagnostic use only

 

Penta target assay (SARS-CoV-2 RdRp and N genes, Influenza A M1 gene, Influenza B NS2 gene and human RP gene)
Positive controls to validate assays included
Internal control to confirm extraction / inhibition included

High Sensitivity: Early virus detection and diagnosis, detects as low as 250 copies/mL of SARS-CoV-2, 750 copies/mL of Influenza A and 1250 copies/mL of Influenza B viral RNA (LoD) sample.
Precision: Coefficient of variation (CV) < 2.77%, 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 Applied Biosystem® 7500 FAST, Applied Biosystem® QuantStudio 5, Bio-Rad® CFX96
Fast Time: < 1h30min from nucleic acid extraction to results.
Minimal Sample Input: As low as 2 μL sample needed

 

Description:

NZYTech´s COVID-19 & Flu A/B Multiplex One-Step RT-qPCR Kit (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 and/or Influenza genomes, through common real-time PCR platforms. SARS-CoV-2 is identified by detecting RT-qPCR targets located in RdRp and N genes. In contrast, Influenza A and Influenza B viruses are detected through the amplification of targets located in M1 and NS2 genes, respectively. NZYTech´s COVID-19 & Flu A/B Multiplex One-Step RT-qPCR Kit (IVD) is built to have the broadest detection profile possible whilst remaining specific to the SARS-CoV-2 and Influenza types A and B genomes.

NZYTech’s COVID-19 & Flu A/B Multiplex One-Step RT-qPCR Kit (IVD) is a multiplex assay detecting SARS-CoV-2, Influenza A, Influenza B and Human nucleic acids (acting as an internal positive control). Extracted and purified RNA is transcribed to cDNA and subsequently amplified in a single reaction using five highly specific primers/probe sets, namely those detecting SARS-CoV-2 RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes, Influenza A and B Matrix (M1) and Nonstructural 2 (NS2) specific genes and the human ribonuclease P (RNase P, RP) gene. The kit exploits the so-called TaqMan® principle. During this process, probes specifically anneal to their target genes and upon DNA amplification, through two flanking primers, are subjected to degradation leading to the separation of the reporter dye from the quencher thus resulting in an increase in fluorescence. Detection of the internal control (the human RNase P gene) validates the efficacy of the extraction process as well as the absence of PCR inhibitors potentially present in the human biological samples. To allow identifying the amplification of the five specific targets in a single reaction, SARS-CoV-2, Influenza A/B and human RNase P specific probes are differently labelled, with Texas Red®, FAM™ and HEX™ reporter dyes, respectively. Note that this panel contains a duplex assay in the Texas Red® (SARS-CoV-2 RdRp and N specific target genes) and FAM™ (Influenza A and Influenza B specific target genes) channels. This allows reporting an additive performance of assays for SARS-CoV-2 detection but precludes distinguishing between Influenza A/B infections. In addition, the five primers/probe sets are provided in optimized concentrations guaranteeing that amplification of lower abundant nucleic acids is not compromised when other viral targets are present at higher concentrations.

 

Components:

  • NZYMultiplex One-step RT-qPCR Probe Master Mix (2x)
  • COVID-19 & Flu A/B Primer Mix (20x)
  • COVID-19 & Flu A/B Probe Mix (20x) (Texas Red®, FAM™ and HEX™ labelled)
  • COVID-19 & Flu A/B Positive Control 1 (SARS-CoV-2 ORF1ab, Influenza B NS2 and human RP genes)
  • COVID-19 & Flu A/B Positive Control 2 (SARS-CoV-2 N, Influenza A M1 and human RP genes)
  • 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
ES Instrucciones de Uso
EN Instructions for Use
MSDS PT
MSDS EN
Declaration of Conformity
Certificate of Analysis MD0485ZN051
Certificate of Analysis MD04851ZN091A

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