Fetal RhD genotyping by maternal serum analysis: A two-year experience

Gautier, E; Benachi, Alexandra; Giovangrandi, Yves; Ernault, Pauline; Olivi, Martine; Gaillon, Thierry; Costa, Jean‐Marc

doi:10.1016/j.ajog.2004.10.632

Cited by 84 publications

(50 citation statements)

References 18 publications

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“…Table 2 clearly indicates that a number of researchers concentrated on samples from at risk pregnancies (e.g. Down syndrome), including women who may not resemble the general RhD-negative pregnant population [5,8,9,15,[23][24][25][26]. Since recruitment was carried out selectively, test accuracy reported in such studies might be an overestimate because certain fetal conditions …”

Section: Assessment Against Nipd Proformamentioning

confidence: 99%

“…Only 5 studies made reference to the sensitisation status of the sample population [6,15,16,28,29]. Poor characterisation of the sample population or selective sampling might affect the reliability of reported results equally.…”

Section: Study Populationmentioning

confidence: 99%

“…Poor characterisation of the sample population or selective sampling might affect the reliability of reported results equally. Selective sampling was taken even further in two studies that only recruited RhD-negative pregnant women with RhD-positive fetuses [15,29]. Both studies excluded any possibility of producing false positives and did not sufficiently challenge the test because a certain test outcome was anticipated.…”

Section: Study Populationmentioning

confidence: 99%

“…Seven studies either did not include replicates or did not report them. Protocols for conversion of replicate outcomes into an overall test result differed significantly across the studies, ranging from a requirement for one or more positive replicate outcome [2,13,28,29,30,[32][33][34] to two or more [6,16,25,35] or all replicates [14,15,31,35,36] to be positive for an overall positive result.…”

Section: Study Conduct and Data Analysismentioning

confidence: 99%

“…Several studies have reported high accuracy rates [13][14][15][16] and these have prompted the initiation of larger scale trials in the Netherlands, Germany and the UK [17][18]. Reports in the literature have already led to initial use of the test for management of sensitised women.…”

Section: Introductionmentioning

confidence: 99%

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Non-invasive fetal RHD genotyping tests: A systematic review of the quality of reporting of diagnostic accuracy in published studies

Freeman

Szczepura

Osipenko

2009

European Journal of Obstetrics & Gynecology and Reproductiv

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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). Largescale, prospective trials are only now underway. Estimates of the technical performance of these tests are currently based on results from small-scale studies, together with formal meta-analysis. The issue of early assessment of test performance is one faced by many new genetic tests. As part of a wider study we have investigated the quality of reporting of diagnostic accuracy in publications and produced guidelines for future studies.A systematic search of the literature identified 27 papers which met predefined inclusion criteria. All 27 papers were, first, assessed against an international quality (STARD) checklist for reporting of diagnostic accuracy and, second, against our own in-house NIPD proforma to assess the implications of the quality of reporting specifically for the RhD NIPD test. Authors were found to generally present an optimistic view of NIPD, bearing in mind weaknesses identified in reporting and conduct of their studies and the analysis of results, as evidenced by the low STARD scores. The NIPD proforma identified that specific biases were potentially introduced through selective population sampling and/or failure to report the make-up of the population tested, omission of inconclusive results, inconsistencies in the handling of repeat results on a sample, and lack of adequate controls. These factors would inevitably affect the validity of diagnostic accuracy as reported in individual publications, as well as any subsequent meta-analyses. Together, published reports to date may provide a biased picture of the actual potential of NIPD testing for fetal RHD genotyping. Generalisation of the available evidence on diagnostic accuracy, especially to large-scale implementation of NIPD testing of non-sensitised women, will also require that decision makers consider further aspects such as test reliability and cost of routine testing in clinical practice.It is recommended that all studies of diagnostic accuracy of NIPD tests adhere to the STARD quality checklist in order to improve reporting, thereby, minimising bias and increasing the comparability of studies. 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 s...

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Section: Assessment Against Nipd Proformamentioning

confidence: 99%

Section: Study Populationmentioning

confidence: 99%

Section: Study Populationmentioning

confidence: 99%

Section: Study Conduct and Data Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Non-invasive fetal RHD genotyping tests: A systematic review of the quality of reporting of diagnostic accuracy in published studies

Freeman

Szczepura

Osipenko

2009

European Journal of Obstetrics & Gynecology and Reproductiv

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Molecular Biological Analyses and Molecular Pathology in Clinical Chemistry

Lo¹,

Wong²,

Tsui³

et al. 2009

Encyclopedia of Analytical Chemistry

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The introduction of powerful methods for the analysis of nucleic acids started a revolution in medicine, opening up a new field of molecular diagnosis. The core technologies of molecular diagnosis involve techniques for the amplification and characterization of nucleic acids. These techniques have enabled the diagnosis of many diseases with unprecedented sensitivity and specificity. As research tools, these methods have increased our understanding of many diseases on a molecular level, with the unraveling of the molecular pathology of many common disorders. The foundation for the rapid and continual development of molecular pathology received a boost from the genome‐wide scale analyses of the human genome, such as the Human Genome Project (HGP) and the HapMap Project, which have provided the essential genetic blueprint for future investigations.

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Microarray abnormal results

Zneimer

2014

Cytogenetic Abnormalities

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Fetal RhD genotyping by maternal serum analysis: A two-year experience

Cited by 84 publications

References 18 publications

Non-invasive fetal RHD genotyping tests: A systematic review of the quality of reporting of diagnostic accuracy in published studies

Non-invasive fetal RHD genotyping tests: A systematic review of the quality of reporting of diagnostic accuracy in published studies

Molecular Biological Analyses and Molecular Pathology in Clinical Chemistry

Microarray abnormal results

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