Ebola Zaire Virus Detection
Date of reception of the dossier
07.07.2022
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
Real–time reverse transcription polymerase chain reaction
(RT-PCR) test for the qualitative detection of Zaire Ebola
virus’ RNA in EDTA venous whole blood or peripheral blood
in adults.
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)
Glycoprotein (GP)
gene and/or
nucleoprotein (NP)
gene
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Aid to diagnosis
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.
Identification of
Ebola Zaire virus
P4
whether it is automated or not
Automated
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
EDTA venous
whole blood or
peripheral blood
from finger-stick
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Adults with signs
and symptoms of
Ebola Virus Disease
(EVD) in conjunction with epidemiological
risk factors
P8
intended user
Trained users in a
laboratory setting
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.