SARS-CoV-2, Influenza A, Influenza B Detection and Differentiation
Date of reception of the dossier
29.10.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
The device is a qualitative real-time PCR test for the simultaneously detection and differentiation of SARS-CoV-2,
Influenza A, and Influenza B in respiratory specimens (Nasopharyngeal swab/nasal swab)
Intended purpose
P1
what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)
- SARS-CoV-2 ORF1 a/b non-structural region and nucleocapsid protein gene
- Influenza A matrix gene
- Influenza B non-structural protein gene
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Detection and differentiation of Influenza A, Influenza B, and SARS-CoV-2 in
respiratory specimens
P3
the specific disorder, condition or risk factor of
interest that it is intended to detect, define or
differentiate e.g. hepatitis C infection, exposure to SARS-CoV-2, risk of HIV transmission in blood transfusion etc.
Influenza A infection, Influenza B infection,
SARS CoV-2 infection
P4
whether it is automated or not
Yes, automated
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
Nasopharyngeal swab
Nasal Swab
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Individuals suspected of respiratory viral
infection consistent with COVID-19 by their healthcare provider
P8
intended user
Health professionals or trained operators
who are proficient in using the automated
platform, including in Near Patient Testing
environments
Technology
T1
principle of the assay method or principles of operation of the instrument e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.
Real-time PCR