Plasmodium DNA and RNA Detection
Date of reception of the dossier
Ongoing performance evaluation
Notified Body number
–
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended for the screening of donor samples for the direct detection of Plasmodium DNA and RNA in whole blood samples. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating.
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)
- Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and 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 screening of donor samples for the direct detection of Plasmodium DNA and RNA in whole blood samples. It is also intended for use in testing whole blood samples to screen organ and tissue donors when 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.
Malaria infection
P4
whether it is automated or not
Automated assay
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative assay
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.
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