Parvovirus B19 DNA Quantification, Hepatitis A Virus RNA Detection
Date of reception of the dossier
21.09.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma.
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)
- parvovirus B19 genotypes 1, 2, and 3 DNA
- Hepatitis A virus (HAV) genotypes I, II, and III RNA
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 as an in-
process test to quantify parvovirus B19
DNA alone or to simultaneously quantify
parvovirus B19 DNA and detect HAV RNA
in plasma intended for further
manufacture collected from donors of
whole blood, blood components, or
plasma.
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.
Parvovirus B19 and HAV transmission in
blood transfusion
P4
whether it is automated or not
Automated
P5
whether it is qualitative, semi-quantitative or
quantitative
Parvovirus B19 is quantitative; HAV is
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
Donors of whole blood and blood
components. Organ and tissue donors.
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