Title
Sensitivity of fetal RHD screening for safe guidance of targeted anti-D immunoglobulin prophylaxis: Prospective cohort study of a nationwide programme in the Netherlands
Author
de Haas, M.
Thurik, F.F.
van der Ploeg, C.P.B.
Veldhuisen, B.
Hirschberg, H.
Soussan, A.A.
Woortmeijer, H.
Abbink, F.
Page-Christiaens, G.C.M.L.
Scheffer, P.G.
van der Schoot, C.E.
Publication year
2016
Abstract
Objective To determine the accuracy of non-invasive fetal testing for the RHD gene in week 27 of pregnancy as part of an antenatal screening programme to restrict anti-D immunoglobulin use to women carrying a child positive for RHD. Design Prospectively monitoring of fetal RHD testing accuracy compared with serological cord blood typing on introduction of the test. Fetal RHD testing was performed with a duplex real time quantitative polymerase chain reaction, with cell-free fetal DNA isolated from 1 mL of maternal plasma The study period was between 4 July 2011 and 7 October 2012. The proportion of women participating in screening was determined. Setting Nationwide screening programme, the Netherlands. Tests are performed in a centralised setting. Participants 25 789 RhD negative pregnant women. Main outcom e measures Sensitivity, specificity, false negative rate, and false positive rate of fetal RHD testing compared with serological cord blood typing; proportion of technical failures; and compliance to the screening programme. Results A fetal RHD test result and serological cord blood result were available for 25 789 pregnancies. Sensitivity for detection of fetal RHD was 99.94% (95% confidence interval 99.89% to 99.97%) and specificity was 97.74% (97.43% to 98.02%). Nine false negative results for fetal RHD testing were registered (0.03%, 95% confidence interval 0.01% to 0.06%). In two cases these were due to technical failures. False positive fetal RHD testing results were registered for 225 samples (0.87%, 0.76% to 0.99%). Weak RhD expression was shown in 22 of these cases, justifying anti-D immunoglobulin use. The negative and positive predictive values were 99.91% (95% confidence interval 99.82% to 99.95%) and 98.60% (98.40% to 98.77%), respectively. More than 98% of the women participated in the screening programme. Conclusions Fetal RHD testing in week 27 of pregnancy as part of a national antenatal screening programme is highly reliable and can be used to target both antenatal and postnatal anti-D immunoglobulin use.
Subject
ELSS - Earth, Life and Social Sciences
Life
Healthy Living
Healthy for Life
Screening
Pregnant
RHD
Women
Netherlands
CH - Child Health
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http://resolver.tudelft.nl/uuid:c7660bec-6b2e-402f-8910-9c48f5e8afbd
DOI
https://doi.org/10.1136/bmj.i5789
TNO identifier
574298
ISSN
0959-8146
Source
BMJ, 355 (355)
Document type
article