scholarly journals Recommendation for validation and quality assurance of non‐invasive prenatal testing for foetal blood groups and implications for IVD risk classification according to EU regulations

Vox Sanguinis ◽  
2021 ◽  
Author(s):  
Frederik Banch Clausen ◽  
Åsa Hellberg ◽  
Gregor Bein ◽  
Peter Bugert ◽  
Dieter Schwartz ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Prenatal Testing ◽  
Blood Groups ◽  
Risk Classification ◽  
Non Invasive ◽  
Foetal Blood

Quality assurance and standardization in view of non-invasive prenatal testing (NIPT)

2016 ◽  
Vol 40 (5) ◽  
Author(s):  
Peter W. Schenk
Keyword(s):  
Quality Assurance ◽  
Molecular Genetics ◽  
Prenatal Testing ◽  
Point Of View ◽  
Quality Requirements ◽  
Iso Standard ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Non Invasive ◽  
Development And Utilization

Abstract:The development and utilization of non-invasive prenatal tests have provided new and exciting challenges for quality assurance. Quality managers, scientists and technicians have been faced with the question of appropriate validation and quality controls for these innovative tests. Guidelines on quality assurance and quality control are still lacking and the need is growing inexorably. To integrate non-invasive prenatal tests into existing guidelines, attention must be paid to ISO standard 15189 which describes the requirements for medical laboratories and therefore diagnostic molecular genetics laboratories. Performing the test in an accredited molecular genetics laboratory according to ISO 15189 ensures the adherence to, and compliance with, all important principles. In this article, an overview of quality requirements applied to non-invasive prenatal testing is given from a quality manager’s point of view.

Moving Towards Routine Non-Invasive Prenatal Testing (NIPT): Challenges Related to Women’s Autonomy

2018 ◽  
Vol 2 (2) ◽  
pp. 1-1 ◽  
Author(s):  
Stanislav Birko ◽  
◽  
Marie-Eve Lemoine ◽  
Minh Thu Nguyen ◽  
Vardit Ravitsky ◽  
...  
Keyword(s):  
Prenatal Testing ◽  
Women’S Autonomy ◽  
Women's Autonomy ◽  
Non Invasive

OP75 Facts And Values In Health Technology Assessment: The Case Of Non-Invasive Prenatal Testing

2019 ◽  
Vol 35 (S1) ◽  
pp. 19-19
Author(s):  
Bart Bloemen ◽  
Maarten Jansen ◽  
Wouter Rijke ◽  
Wija Oortwijn ◽  
Gert Vanderwilt
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Prenatal Testing ◽  
Health Technology ◽  
Non Invasive ◽  
Relevant Evidence ◽  
Healthcare Technologies ◽  
General Abstract ◽  
Structured Questionnaire

IntroductionHealth Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.MethodsFive reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.ResultsOur results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.ConclusionsThere is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.

scholarly journals Non-Invasive Prenatal Testing: Current Perspectives and Future Challenges

Genes ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 15
Author(s):  
Luigi Carbone ◽  
Federica Cariati ◽  
Laura Sarno ◽  
Alessandro Conforti ◽  
Francesca Bagnulo ◽  
...  
Keyword(s):  
Prenatal Screening ◽  
Prenatal Testing ◽  
Non Invasive ◽  
Fetal Dna ◽  
Cell Free Fetal Dna ◽  
Common Causes ◽  
Future Challenges ◽  
Neurodevelopmental Impairment ◽  
Fetal Aneuploidies ◽  
Made In

Fetal aneuploidies are among the most common causes of miscarriages, perinatal mortality and neurodevelopmental impairment. During the last 70 years, many efforts have been made in order to improve prenatal diagnosis and prenatal screening of these conditions. Recently, the use of cell-free fetal DNA (cff-DNA) testing has been increasingly used in different countries, representing an opportunity for non-invasive prenatal screening of pregnant women. The aim of this narrative review is to describe the state of the art and the main strengths and limitations of this test for prenatal screening of fetal aneuploidies.

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