Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance
Author:
Affiliation:
1. From the Department of Pathology, The University of Alabama, Birmingham
Publisher
Archives of Pathology and Laboratory Medicine
Subject
Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine
Link
https://meridian.allenpress.com/aplm/article-pdf/148/2/136/3322693/i1543-2165-148-2-136.pdf
Reference9 articles.
1. Quality management in laboratory medicine;Wilkinson,2019
2. Diagnostic quality assurance pilot: a model to demonstrate comparative laboratory test performance with an oncology companion diagnostic assay;Zehnbauer;J Mol Diagn,2017
3. Reference samples to compare next-generation sequencing test performance for oncology therapeutics and diagnostics;Pfeifer;Am J Clin Pathol,2022
4. SPOT/Dx pilot reanalysis and College of American Pathologists proficiency testing for KRAS and NRAS demonstrate excellent laboratory performance [published online ahead of print September 30, 2023];Zehir;Arch Pathol Lab Med
5. Proficiency testing of standardized samples shows very high interlaboratory agreement for clinical next-generation sequencing-based oncology assays;Merker;Arch Pathol Lab Med,2019
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