SARS-CoV-2 genomic RNA Detection
Date of reception of the dossier
04.11.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is an in vitro nucleic acid amplification test intended
for qualitative detection of SARS-CoV-2 genomic RNA by real-time polymerase chain reaction (PCR) method.
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 RdRp, E and N genes
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Diagnostics and screening of
SARS-CoV-2 and aid to diagnosis
of COVID-19
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.
COVID -19 disease,
exposure to SARS-CoV-2
P4
whether it is automated or not
Manual
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
RNA extracted from
nasopharyngeal swab (in transport media: UTM (Copan),
PBS or Physiological saline solution); anterior 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
EU population; Indicated and
preventive testing of COVID-19
P8
intended user
Trained staff in laboratories
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 polymerase chain
reaction (PCR) – amplification of
the specific Target Sequence and
detection using probes with
fluorophore-based detection