Establishment and Validation of Analytical Reference Panels for the Standardization of Quantitative BCR-ABL1 Measurements on the International Scale

dc.creatorWhite, HE
dc.creatorHedges, J
dc.creatorBendit, I
dc.creatorBranford, S
dc.creatorColomer, D
dc.creatorHochhaus, A
dc.creatorHughes, T
dc.creatorKamel-Reid, S
dc.creatorKim, DW
dc.creatorModur, V
dc.creatorMuller, MC
dc.creatorPagnano, KB
dc.creatorPane, F
dc.creatorRadich, J
dc.creatorCross, NCP
dc.creatorLabourier, E
dc.date2013
dc.dateJUN
dc.date2014-07-30T17:27:36Z
dc.date2015-11-26T17:14:45Z
dc.date2014-07-30T17:27:36Z
dc.date2015-11-26T17:14:45Z
dc.date.accessioned2018-03-29T00:03:03Z
dc.date.available2018-03-29T00:03:03Z
dc.identifierClinical Chemistry. Amer Assoc Clinical Chemistry, v. 59, n. 6, n. 938, n. 948, 2013.
dc.identifier0009-9147
dc.identifierWOS:000321548500013
dc.identifier10.1373/clinchem.2012.196477
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/65609
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/65609
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1281884
dc.descriptionBACKGROUND: Current guidelines for managing Philadelphia-positive chronic myeloid leukemia include monitoring the expression of the BCR-ABL1 (breakpoint cluster region/c-abl oncogene 1, nonreceptor tyrosine kinase) fusion gene by quantitative reverse-transcription PCR (RT-qPCR). Our goal was to establish and validate reference panels to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate global standardization on the international scale (IS). METHODS: Four-level secondary reference panels were manufactured under controlled and validated processes with synthetic Armored RNA Quant molecules (Asuragen) calibrated to reference standards from the WHO and the NIST. Performance was evaluated in IS reference laboratories and with non-IS-standardized RT-qPCR methods. RESULTS: For most methods, percent ratios for BCR-ABL1 e13a2 and e14a2 relative to ABL1 or BCR were robust at 4 different levels and linear over 3 logarithms, from 10% to 0.01% on the IS. The intraassay and interassay imprecision was <2-fold overall. Performance was stable across 3 consecutive lots, in multiple laboratories, and over a period of 18 months to date. International field trials demonstrated the commutability of the reagents and their accurate alignment to the IS within the intra-and interlaboratory imprecision of IS-standardized methods. CONCLUSIONS: The synthetic calibrator panels are robust, reproducibly manufactured, analytically calibrated to the WHO primary standards, and compatible with most BCR-ABL1 RT-qPCR assay designs. The broad availability of secondary reference reagents will further facilitate interlaboratory comparative studies and independent quality assessment programs, which are of paramount importance for worldwide standardization of BCR-ABL1 monitoring results and the optimization of current and new therapeutic approaches for chronic myeloid leukemia. (C) 2013 American Association for Clinical Chemistry
dc.description59
dc.description6
dc.description938
dc.description948
dc.descriptionAsuragen
dc.descriptionNovartis
dc.descriptionUK Department of Health
dc.languageen
dc.publisherAmer Assoc Clinical Chemistry
dc.publisherWashington
dc.publisherEUA
dc.relationClinical Chemistry
dc.relationClin. Chem.
dc.rightsfechado
dc.sourceWeb of Science
dc.subjectChronic Myeloid-leukemia
dc.subjectBcr-abl Transcripts
dc.subjectHarmonizing Current Methodology
dc.subjectTyrosine Kinase Inhibitors
dc.subjectResidual Disease Detection
dc.subjectPolymerase-chain-reaction
dc.subjectRt-pcr
dc.subjectReporting Scale
dc.subjectCancer Program
dc.subjectRna
dc.titleEstablishment and Validation of Analytical Reference Panels for the Standardization of Quantitative BCR-ABL1 Measurements on the International Scale
dc.typeArtículos de revistas


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