Analytical Validation of Androgen Receptor Splice Variant 7 Detection in a Clinical Laboratory Improvement Amendments (CLIA) Laboratory Setting
نویسندگان
چکیده
منابع مشابه
Laboratory testing under the microscope: the Clinical Laboratory Improvement Amendments of 1988.
Currently, most clinical laboratories in the United States are not subject to significant federal oversight. Beginning in 1992, however, the Clinical Laboratory Improvement Amendments of 1988 n1 (CLIA-88) will subject hundreds of thousands of large and small clinical laboratories to a complex assortment of federal requirements. In particular, CLIA-88 will require laboratories engaged in medical...
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BACKGROUND The androgen receptor splice variant-7 (AR-V7) has been implicated in the development of castration-resistant prostate cancer (CRPC) and resistance to abiraterone and enzalutamide. OBJECTIVE To develop a validated assay for detection of AR-V7 protein in tumour tissue and determine its expression and clinical significance as patients progress from hormone-sensitive prostate cancer (...
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Mutation detection plays an increasingly significant role in clinical diagnostic testing, posing formidable challenges for laboratories. The expanding indications for clinical molecular testing and the nuances of interpreting test results are discussed. Methods for screening mutation detection platforms and monitoring assay reliability are presented, and results of platform comparisons are desc...
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Margaret L. Gulley, MD; Rita M. Braziel, MD; Kevin C. Halling, MD, PhD; Eric D. Hsi, MD; Jeffrey A. Kant, MD, PhD; Marina N. Nikiforova, MD; Jan A. Nowak, MD, PhD; Shuji Ogino, MD, PhD; Andre Oliveira, MD; Herbert F. Polesky, MD; Lawrence Silverman, PhD; Raymond R. Tubbs, DO; Vivianna M. Van Deerlin, MD, PhD; Gail H. Vance, MD; James Versalovic, MD, PhD; for the Molecular Pathology Resource Com...
متن کاملGenetic testing and the clinical laboratory improvement amendments of 1988: present and future.
CLIA '88 superseded CLIA '67. CLIA '88 set standards designed to improve quality and expanded federal oversight to virtually all clinical laboratories in the United States. Presumably because genetics testing was then in its infancy, CLIA '88 did not devote a special section to genetics testing. Biochemical and immunochemical tests used to evaluate inborn errors of metabolism and other genetic ...
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ژورنال
عنوان ژورنال: The Journal of Molecular Diagnostics
سال: 2017
ISSN: 1525-1578
DOI: 10.1016/j.jmoldx.2016.08.003