NGenePlex nCoV/FluA.B Detection Kit

The NGenePlex ™ nCoV qRT-PCR Kit is a real-time reverse transcription-polymerase chain reaction (RT-PCR) assay reagent designed for the qualitative detection of SARS-CoV-2 nucleic acid from infected or suspected patients of COVID-19.

  • The NGenePlex ™ nCoV qRT-PCR Kit is designed for use by qualified laboratory personnel specifically trained and instructed in qRT-PCR techniques as an in vitro diagnostic kit.
  • In addition, the intended use is to detect SARS-CoV-2 nucleic acid in infected or suspected COVID-19 patients with symptoms including fever, cough, fatigue, shortness of breath, and loss of smell and taste.
  • Samples can be collected from a respiratory tract, such as a nasal, nasopharyngeal (PN), or oropharyngeal (OP) swab.

Specifications

certification: CE-IVD

Number: 96 tests

Target genes: RdRp and N genes in SARS-CoV-2

Sample types: human nasopharyngeal swab (PN), oropharyngeal swab (OP)

Validated Instruments:

  • * CFX96 ™ Real-Time PCR Detection System (Bio-Rad)
  • ABI 7500 Real-Time PCR System (ThermoFisher Scientific)
  • QuantStudio 3 Real-Time PCR Instrument (ThermoFisher Scientific)
  • LightCycler® 480 System (Roche)

Fluorometer channel:

  • FAM (RdRp)
  • HEX / VIC (N)
  • Cal Red 610 / Texas Red (IC: Human RNase P)

The primers and probes of the NGenePlex ™ nCoV qRT-PCR kit were designed to target the RdRP1 gene in an open reading frame (orf1ab) that encodes non-structural proteins (nsp) for replication and the N gene that encodes the nucleocapsid protein. In addition, an additional primer-probe set is included in the kit to detect the human RNase P gene as an internal control (IC).

This kit contains a ready-to-use, one-step system for the detection of 2019-nCoV by reverse transcription-polymerase chain reaction (RT-PCR) in the real-time PCR system. The reagent mix contains target sequences and target probes for specific amplification of virus RNA. The reaction is performed in a real-time RT-PCR step, which includes the following;

  • A reverse transcription (RT), where the RNA of the virus is transcribed into cDNA.
  • Amplification (PCR), where a thermostable DNA polymerase is used to amplify specific gene fragments.
  • Quantification, where the fluorescence is emitted and measured by the optical unit of the systems in real-time during the PCR.

Detection of the amplified virus cDNA fragment is performed in the FAM fluorimetric channel, HEX / VIC channel and Cal Red 610 / Texas Red / ROX channel with the fluorescent quencher NFQ-MGB.

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