Babesia DNA and RNA Detection Test
Date of reception of the dossier
30.09.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, 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)
- Babesia (B. microti, B, duncani, B. divergens, and B. venatorum)
- DNA
- 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 the direct
detection of Babesia (B. microti, B,
duncani, B. divergens, and B.
venatorum) DNA and RNA in whole
blood samples from individual human
donors, including donors of whole
blood and 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.
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.
Babesia 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
Whole Blood
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 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