Design and Analytic Validation of BCR-ABL1 Quantitative Reverse Transcription Polymerase Chain Reaction Assay for Monitoring Minimal Residual Disease.

Posted by rob on January 9, 2012 under Uncategorized | Comments are off for this article

Conclusions.-Validation of laboratory-developed quantitative molecular tests requires careful planning and execution to adequately address all required analytic performance parameters. How these are addressed depends on the potential for technical errors and confidence required for a given test result. We demonstrate how one laboratory validated and clinically implemented a quantitative BCR-ABL1 assay that can be used for the management of patients with chronic myelogenous leukemia.
PMID: 22208485 [PubMed - in process] (Source: Archives of Pathology and Laboratory Medicine)
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