Zika Virus RNA Detection
Date of reception of the dossier
24.09.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
The device is a qualitative in vitro nucleic acid screening test
for the direct detection of Zika virus RNA in human 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)
- Zika Virus 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 to screen donor samples for Zika virus RNA in plasma samples
from individual human donors,
including donors of whole blood
and blood omponents, and
other living donors. This test is also intended for use to screen organ and tissue donors when
donor samples are obtained while the donor’s heart is still
beating.
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.
Zika virus 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 and other
living donors.
Organ and tissue donors.
P8
intended user
Trained laboratory professionals
who are proficient in using the
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