Analytical validation of a highly sensitive, multiplexed chronic myeloid leukemia monitoring system targeting BCR-ABL1 RNA

This study describes the analytical performance of the QuantideX qPCR BCR-ABL IS Kit, the first Federal Drug Administration –cleared assay designed to monitor BCR-ABL1 fusion transcripts isolated from peripheral blood specimens from patients with chronic myeloid leukemia. This multiplex RT-qPCR assay amplifies both e13a2 and e14a2 major BCR-ABL1 transcripts and the reference target ABL1. The test results are provided i n international scale (IS) values by incorporating armored RNA-based calibrators that have defined IS values tied directly to the WHO BCR-ABL1 Primary Reference Materials, without the necessity of determining and maintaining conversion factors.

Source: Journal of Molecular Diagnostics - April 22, 2019 Category: Pathology Authors: Justin T. Brown, Ion J. Beldorth, Walairat Laosinchai-Wolf, Marie E. Fahey, Keri L. Jefferson, Adam K. Ruskin, Jacquelyn J. Roth, Li Cai, Christopher D. Watt, Richard D. Press, Fei Yang, John B. Hedges, Bernard F. Andruss Tags: Regular Article Source Type: research