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


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 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


whether it is automated or not

Automated assay


whether it is qualitative, semi-quantitative or

Qualitative assay


type of specimen(s)
e.g. whole blood, serum, saliva etc

Whole blood


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.


intended user

Trained laboratory professionals 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.

Real-time PCR

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