| 1. |
- Kanai, M, et al.
(författare)
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- 2023
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swepub:Mat__t
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| 2. |
- Niemi, MEK, et al.
(författare)
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- 2021
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swepub:Mat__t
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| 3. |
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| 4. |
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| 5. |
- Clausen, Frederik Banch, et al.
(författare)
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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
- 2022
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Ingår i: Vox Sanguinis. - : Wiley. - 0042-9007 .- 1423-0410. ; 117:2, s. 157-165
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Forskningsöversikt (refereegranskat)abstract
- Background and Objectives: Non-invasive assays for predicting foetal blood group status in pregnancy serve as valuable clinical tools in the management of pregnancies at risk of detrimental consequences due to blood group antigen incompatibility. To secure clinical applicability, assays for non-invasive prenatal testing of foetal blood groups need to follow strict rules for validation and quality assurance. Here, we present a multi-national position paper with specific recommendations for validation and quality assurance for such assays and discuss their risk classification according to EU regulations. Materials and Methods: We reviewed the literature covering validation for in-vitro diagnostic (IVD) assays in general and for non-invasive foetal RHD genotyping in particular. Recommendations were based on the result of discussions between co-authors. Results: In relation to Annex VIII of the In-Vitro-Diagnostic Medical Device Regulation 2017/746 of the European Parliament and the Council, assays for non-invasive prenatal testing of foetal blood groups are risk class D devices. In our opinion, screening for targeted anti-D prophylaxis for non-immunized RhD negative women should be placed under risk class C. To ensure high quality of non-invasive foetal blood group assays within and beyond the European Union, we present specific recommendations for validation and quality assurance in terms of analytical detection limit, range and linearity, precision, robustness, pre-analytics and use of controls in routine testing. With respect to immunized women, different requirements for validation and IVD risk classification are discussed. Conclusion: These recommendations should be followed to ensure appropriate assay performance and applicability for clinical use of both commercial and in-house assays.
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| 6. |
- Fernandez, David C. Del Rey, et al.
(författare)
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Entropy-stable p-nonconforming discretizations with the summation-by-parts property for the compressible Navier-Stokes equations
- 2020
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Ingår i: Computers & Fluids. - : PERGAMON-ELSEVIER SCIENCE LTD. - 0045-7930 .- 1879-0747. ; 210
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Tidskriftsartikel (refereegranskat)abstract
- The entropy-conservative/stable, curvilinear, nonconforming, p-refinement algorithm for hyperbolic conservation laws of Del Rey Fernandez et al. (2019) is extended from the compressible Euler equations to the compressible Navier-Stokes equations. A simple and flexible coupling procedure with planar interpolation operators between adjoining nonconforming elements is used. Curvilinear volume metric terms are numerically approximated via a minimization procedure and satisfy the discrete geometric conservation law conditions. Distinct curvilinear surface metrics are used on the adjoining interfaces to construct the interface coupling terms, thereby localizing the discrete geometric conservation law constraints to each individual element. The resulting scheme is entropy conservative/stable, element-wise conservative, and freestream preserving. Viscous interface dissipation operators that retain the entropy stability of the base scheme are developed. The accuracy and stability of the resulting numerical scheme are shown to be comparable to those of the original conforming scheme in Carpenter et al. (2014) and Parsani et al. (2016), i.e., this scheme achieves similar to p 1/2 convergence on geometrically high-order distorted element grids; this is demonstrated in the context of the viscous shock problem, the Taylor-Green vortex problem at a Reynolds number of Re = 1, 600, and a subsonic turbulent flow past a sphere at Re = 2, 000. (C) 2020 Published by Elsevier Ltd.
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