دورية أكاديمية
أعرض في EDS

Multi-centre analytical performance verification of an IVD assay to quantify donor-derived cell-free DNA in solid organ transplant recipients.

التفاصيل البيبلوغرافية
العنوان: Multi-centre analytical performance verification of an IVD assay to quantify donor-derived cell-free DNA in solid organ transplant recipients.
المؤلفون: Casas S; CareDx, Brisbane, California, USA., Tangprasertchai NS; CareDx, Brisbane, California, USA., Oikonomaki K; Genotypos Science Labs, Athens, Greece., Mathers S; Transplantation Laboratory, Manchester University NHS Foundation Trust, Manchester, UK., Sollet ZC; Transplantation Immunology Unit and National Reference Laboratory for Histocompatibility, Geneva University Hospitals, Geneva, Switzerland., Samara S; Genotypos Science Labs, Athens, Greece., Liu J; CareDx, Brisbane, California, USA., Burlinson ND; Transplantation Laboratory, Manchester University NHS Foundation Trust, Manchester, UK., Constantoulakis P; Genotypos Science Labs, Athens, Greece., Villard J; Transplantation Immunology Unit and National Reference Laboratory for Histocompatibility, Geneva University Hospitals, Geneva, Switzerland., Viard T; CareDx, Brisbane, California, USA.
المصدر: HLA [HLA] 2024 May; Vol. 103 (5), pp. e15518.
نوع المنشور: Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Wiley Blackwell Country of Publication: England NLM ID: 101675570 Publication Model: Print Cited Medium: Internet ISSN: 2059-2310 (Electronic) Linking ISSN: 20592302 NLM ISO Abbreviation: HLA Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Oxford : Wiley Blackwell, [2016]-
مواضيع طبية MeSH: Cell-Free Nucleic Acids*/blood , High-Throughput Nucleotide Sequencing*/methods , Organ Transplantation* , Tissue Donors* , Graft Rejection*/diagnosis , Graft Rejection*/blood , Graft Rejection*/genetics , Transplant Recipients*, Humans ; Reproducibility of Results ; Biomarkers/blood
مستخلص: Donor-derived cell-free DNA (dd-cfDNA) has been widely studied as biomarker for non-invasive allograft rejection monitoring. Earlier rejection detection enables more prompt diagnosis and intervention, ultimately improving patient treatment and outcomes. This multi-centre study aims to verify analytical performance of a next-generation sequencing-based dd-cfDNA assay at end-user environments. Three independent laboratories received the same experimental design and 16 blinded samples to perform cfDNA extraction and the dd-cfDNA assay workflow. dd-cfDNA results were compared between sites and against manufacturer validation to evaluate concordance, reproducibility, repeatability and verify analytical performance. A total of 247 sample libraries were generated across 18 runs, with completion time of <24 h. A 96.0% first pass rate highlighted minimal failures. Overall observed versus expected dd-cfDNA results demonstrated good concordance and a strong positive correlation with linear least squares regression r 2  = 0.9989, and high repeatability and reproducibility within and between sites, respectively (p > 0.05). Manufacturer validation established limit of blank 0.18%, limit of detection 0.23% and limit of quantification 0.23%, and results from independent sites verified those limits. Parallel analyses illustrated no significant difference (p = 0.951) between dd-cfDNA results with or without recipient genotype. The dd-cfDNA assay evaluated here has been verified as a reliable method for efficient, reproducible dd-cfDNA quantification in plasma from solid organ transplant recipients without requiring genotyping. Implementation of onsite dd-cfDNA testing at clinical laboratories could facilitate earlier detection of allograft injury, bearing great potential for patient care.
(© 2024 The Authors. HLA: Immune Response Genetics published by John Wiley & Sons Ltd.)
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معلومات مُعتمدة: CareDx
فهرسة مساهمة: Keywords: AlloSeq; NGS; SNPs; allograft; cfDNA; dd‐cfDNA; liquid biopsy; transplant biomarker; transplant surveillance; transplantation
المشرفين على المادة: 0 (Cell-Free Nucleic Acids)
0 (Biomarkers)
تواريخ الأحداث: Date Created: 20240511 Date Completed: 20240511 Latest Revision: 20240610
رمز التحديث: 20240611
DOI: 10.1111/tan.15518
PMID: 38733247
قاعدة البيانات: MEDLINE
الوصف
تدمد:2059-2310
DOI:10.1111/tan.15518