Chikungunya virus (CHIKV) RNA and dengue virus (DENV) RNA Detection
Date of reception of the dossier
Notified Body number
Internal PECP dossier #
In vitro diagnostic medical device
This test is a qualitative in vitro test for the direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV)
serotypes 1-4 RNA in human plasma.
what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
The test is intended for use to screen donor samples for CHIKV RNA or DENV RNA alone or to simultaneously screen for both CHIKV and DENV RNA in plasma from individual human donors, including donors of whole
blood, blood components, 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.
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.
Chikungunya virus (CHIKV) and dengue virus (DENV) transmission in blood transfusion.
whether it is automated or not
whether it is qualitative, semi-quantitative or
type of specimen(s)
e.g. whole blood, serum, saliva etc
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, blood
components and other living donors.
Organ and tissue donors.
Trained laboratory professionals who are proficient in using automated platform
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.