West Nile Virus RNA Detection
Date of reception of the dossier
24.09.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended for detection of West Nile Virus (WNV)
RNA in plasma and serum specimens (blood screening).
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)
- West Nile Virus (WNV) RNA
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Detection of West Nile Virus (WNV) RNA in
plasma and serum specimens (blood
screening)
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.
Reduce risk of transmission of WNV via infected blood transfusion or organ
transplantation
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 and serum
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Human blood donors and human organ and
tissue donors
P8
intended user
qualified clinical laboratory personnel
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.
Qualitative nucleic acid test (NAT) using
target capture, target amplification by
Transcription-Mediated Amplification (TMA) and detection of the amplification products (amplicon) by the Hybridization Protection Assay (HPA)