Hepatitis E Virus RNA Screening
Date of reception of the dossier
22.09.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended to screen donor samples for HEV RNA in plasma samples from individual human donors, including
donors of whole blood, blood components (red cells,
platelets, and plasma), and other living donors.
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)
- Hepatitis E virus (HEV)
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
This test is intended for use to screen
donor samples for HEV RNA in plasma
samples from individual human donors,
including donors of whole blood, blood
components (red cells, platelets, and
plasma), and other living donors.
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.
Hepatitis E virus (HEV) transmission in
blood transfusion
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
Plasma
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Living donors of whole blood and blood
components.
P8
intended user
Trained laboratory professionals
proficient in using automated platform
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