European journal of obstetrics, gynecology, and reproductive biology
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Feb 2009
ReviewNon-invasive fetal RHD genotyping tests: a systematic review of the quality of reporting of diagnostic accuracy in published studies.
Articles reporting the diagnostic accuracy of non-invasive prenatal diagnostic (NIPD) tests for RHD genotyping using fetal material extracted from maternal blood have been published steadily for over a decade. Health care providers in Europe have started to use this technology for management of the small number of sensitised pregnancies (ca. 220-600 per annum in the Netherlands, Germany, France and the UK). Scientists and clinicians are also advocating widespread implementation for the far larger number of non-sensitised RhD-negative pregnancies (ca. 34,000-125,000 per annum in the same countries). ⋯ Researchers should also consider specific shortcomings for NIPD and avoid selective participant sampling; report population characteristics; report handling of replicate sampling as well as their failure rates; and include controls for genotypes tested in the study. Furthermore, meta-analyses should consider the quality, as well as the sample size, of NIPD studies in their analysis. Larger trials, required to produce results that are valid and meaningful for clinical practice, must also adhere to these reporting standards.