Fetal RHD status
Date of reception of the dossier
Ongoing performance evaluation
Notified Body number
–
Internal PECP dossier #
In vitro diagnostic medical device
Test to decide if a prepartum anti-D prophylaxis should be administered to RhD-negative pregnant women
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)
- Fetal RHD status (exons 5, 7 and 10 of the RHD gene)
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
- Aid to decide if a prepartum anti-D prophylaxis should be administered to RhD-negative pregnant women
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.
RHD status of the fetus, as a RhD-positive fetus causes the formation of anti-D IgG antibodies in an RhD-negative mother
P4
whether it is automated or not
Non-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
Extracted human maternal plasma
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Non-immunized RhD-negative pregnant women
P8
intended user
For Professional Use Only (trained users)
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 polymerase chain reaction (PCR) – amplification of the specific Target Sequence using fluorescence-labelled oligonucleotide probes