NGenePlex™ nCoV qRT-PCR Kit

Introduction

NGB-GBD-009W-01E-P

NGenePlex

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

COVID-19 Test Workflow

NGenePlex™ nCoV qRT-PCR Kit is intended for use by qualified laboratory personnel specifically trained and instructed in qRT-PCR techniques as an in vitro diagnostic kit.

Also, intended use for detecting nucleic acid of SARS-CoV-2 from patients infected or suspected of COVID-19 with symptoms including fever, cough, fatigue, shortness of breath, and loss of smell and taste

Specimens can be collected from a respiratory tract such as a nasal, nasopharyngeal (NP), or oropharyngeal (OP) swab.

Specification

NGenePlex™ nCoV qRT-PCR Kit
Certification CE-IVD
Quantity 96 tests
Target genes RdRp and N genes on SARS-CoV-2
Specimen types human nasopharyngeal (NP) swab, oropharyngeal (OP) swab
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)
* Other instruments with suitable fluorometer channels can be compatible.

The primers and probes of NGenePlex™ nCoV qRT-PCR Kit were deigned to target the RdRP1 gene in the open reading frame (orf1ab) encoding non-structural proteins (nsp) for replication and the N gene encoding nucleocapsid protein. Also, 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 one-step, ready-to-use 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 a target sequences and target probes for the specific amplification of virus RNA. The reaction is done in one step real time RT-PCR, including followings;

A reverse transcription (RT), where the virus RNA is transcribed into cDNA.

Amplification (PCR), where a thermostable DNA polymerase is used to amplify the specific gene fragments.

Quantification, where fluorescence is emitted and measured by the real time systems´ optical unit during PCR.

 

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

Product Composition

No. Product Composition Description Cap or
tube Color
Storage
Condition

1

2X One-Step Reaction Mix One-step real-time RT-PCR buffer Clear -20℃

2

One-Step Enzyme Mix DNA polymerase, revers transcriptase Red

3

Probe Mix Primers and probes mix Amber

4

Positive Control Template for RdRp + N (SARS-nCoV-2) and RNase P (human) Yellow

Ordering Information

Cat no. Products Quantity Storage

NGB561V-096

NGenePlex™ nCoV qRT-PCR Kit 96 -20℃

04ZZZ00-00051
(RP-80100)

MVPrep™ Viral RNA/DNA Kit plus 100 RT