Respiratory Infections

Neoplex™ COVID-19 FAST

REF

9246F

Description

Real time PCR test with retrotranscription included for the detection of the N and RdRp genes of SARS-CoV-2 (2019-nCoV) in respiratory samples

Packaging

96 test

Certification

Respiratory infections can be viral and/or bacterial and may present non-specific symptoms. Therefore, a diagnostic tool enables to determine quickly the cause of infection is essential for rapid intervention and a correct therapy. Moreover, syndromic panels are indispensable in respiratory diseases, which are usually seasonal, to control and stop any eventual outbreaks.

Summary Documents Related products Information Request

Summary

Technology

Multiplexing technology

Target

SARS-CoV-2

Genetic region

N – gene
RdRp – gene

Mastermix number

Internal control

Endogenous (beta-globin)

UDG

Yes

Fluorophores

Limit of Detection (LoD)

~9 copies/µL

Analytical specificity

A wide range of pathogens was used to test the assay. No cross-reactivity was found.

Diagnostic sensitivity

100 %

Diagnostic specificity

100 %

Riproducibility

100 %

Specimen

Nasopharyngeal swab
Oropharyngeal swab
Sputum
BAL
Saliva

Validated thermalcyclers

Applied Biosystems™ 7500 (Fast) Real-time PCR Instrument system, 7500 Real-time PCR Instrument system e QuantStudio5 (Thermo Fisher Scientific),
CFX96™ Real-time PCR detection system (Bio-Rad),
Gentier96 Real-time PCR, Rotor-Gene Q 5plex HRM (Qiagen)

Software

NeoPlex Viewer/Easy-NAT