Clinical validation of fetal RHD genotyping in gestational week 27.

By May 2022, all in vitro diagnostic medical devices will need to comply with
the new EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).
This regulation also applies to the non-invasive fetal RHD genotyping platform
at Sanquin Diagnostic Services in Amsterdam, which is since 2011 used for the
national antenatal population screening program PSIE (Prenatal Screening for
Infectious Diseases and Erythrocyte Immunisation). In order to become IVDR
2017/746 compliant and obtain CE marking, the current routinely used RHD
genotyping platform at Sanquin needs to be clinically revalidated in accordance
with IVDR 2017/746.

1. Validation of the currently used fetal RHD genotyping platform according to
IVDR 2017/746 guidelines;
2. Validation of an adapted fetal RHD genotyping platform (different liquid
handling system and DNA isolation kit) according to IVDR 2017/746
guidelines.

Prospective assessment of the platform*s fetal RHD genotyping accuracy in
comparison to the reference standard.

The collection of one tube of cord blood immediately after delivery has minimal
impact on mother and child, since venipuncture of the umbilical cord will be
performed after clamping of the cord. Also, the collection of an extra tube of
blood during the regular blood collection appointment in GW27 represents no
significant burden to the pregnant mother, since both the regular and extra
blood tube will be collected in one and the same venipuncture procedure and
taking into account the small volume of 10 mL of blood. Finally, data
collection concerns fetal RHD genotyping, which is already part of the national
antenatal population screening program and only women participating in this
program will be approached for the study. The study can only be performed with
the group of pregnant RhD-negative women and will provide a benefit to this
group in terms of quality assurance of the RHD genotyping platform at Sanquin.