NZYTech - Model MD04851 - COVID-19 & Flu A/B Multiplex One-Step RT-qPCR Kit, IVD

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.

• 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 93 clinical samples (96-well plate); up to 381 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