Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline
|Publication Date:||1 August 2013|
This document addresses fluorescence in situ hybridization methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification. Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; QA; and evaluation of results are also included. The guideline is intended to facilitate the reproducible production of FISH assays and the interlaboratory comparison of results and diagnostic interpretations, as well as to ensure accuracy in diagnosis.
This document is intended for use by laboratories that develop
tests based on commercially manufactured and laboratory-developed