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Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia

Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia
Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia
Molecular monitoring for patients with chronic myeloid leukaemia (CML) has become an important practice in the era of imatinib therapy. For successful widespread introduction into the mainstream patient monitoring schedule, many procedural aspects of the complex real-time quantitative polymerase chain reaction (RQ-PCR) technique for measuring BCR-ABL transcripts require optimization. Recommendations for harmonizing the differing methodologies have recently been proposed. These recommendations were designed to maximize reliability of analysis for clinical decision making and proposed the adoption of an International Scale of measurement. The purpose of this review is to present the evidence and supporting data for specific recommendations. These recommendations include use of the same source of cells, either blood or marrow, for analysis; for validation of equal PCR amplification efficiencies of cDNA and standards when using a plasmid to construct standard curves and for ensuring ongoing high-level performance by undertaking a quality assurance programme. Clinicians must know the measurement reliability of an RQ-PCR assay to be able to determine the significance of a change in BCR-ABL level. An assay with poor precision limits the clinical usefulness of results. International harmonization should establish RQ-PCR measurement of BCR-ABL as the best method for monitoring treatment response for patients with CML.
standards, rna, research, bcr-abl, pathology, chronic, humans, methods, proteins, australia, blood, review, protein, drug monitoring, therapy, bcr-abl positive, polymerase chain reaction, fusion proteins, messenger, leukemia, patients, reproducibility of results, research support, treatment, analysis, myelogenous, genetics, quality control, decision making
0887-6924
1925-1930
Branford, S.
b3cb17f7-3c04-47be-9b9e-2e9e1f102199
Cross, N.C.
f87650da-b908-4a34-b31b-d62c5f186fe4
Hochhaus, A.
4c0b9da4-adfa-4253-8af7-78cec9e9a24f
Radich, J.
c10289d7-1677-4ea8-a9c2-069462afff0e
Saglio, G.
73d6fc31-81e4-4e8d-9ea3-e08db4d00f10
Kaeda, J.
97eba745-9c30-4333-9235-00c915b12cf6
Goldman, J.
773443db-4283-495f-b2db-60d8227fa393
Hughes, T.
e7ab9d6a-57d7-45d3-9a1b-bc00df50432e
Branford, S.
b3cb17f7-3c04-47be-9b9e-2e9e1f102199
Cross, N.C.
f87650da-b908-4a34-b31b-d62c5f186fe4
Hochhaus, A.
4c0b9da4-adfa-4253-8af7-78cec9e9a24f
Radich, J.
c10289d7-1677-4ea8-a9c2-069462afff0e
Saglio, G.
73d6fc31-81e4-4e8d-9ea3-e08db4d00f10
Kaeda, J.
97eba745-9c30-4333-9235-00c915b12cf6
Goldman, J.
773443db-4283-495f-b2db-60d8227fa393
Hughes, T.
e7ab9d6a-57d7-45d3-9a1b-bc00df50432e

Branford, S., Cross, N.C., Hochhaus, A., Radich, J., Saglio, G., Kaeda, J., Goldman, J. and Hughes, T. (2006) Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia, 20 (11), 1925-1930. (doi:10.1038/sj.leu.2404388).

Record type: Article

Abstract

Molecular monitoring for patients with chronic myeloid leukaemia (CML) has become an important practice in the era of imatinib therapy. For successful widespread introduction into the mainstream patient monitoring schedule, many procedural aspects of the complex real-time quantitative polymerase chain reaction (RQ-PCR) technique for measuring BCR-ABL transcripts require optimization. Recommendations for harmonizing the differing methodologies have recently been proposed. These recommendations were designed to maximize reliability of analysis for clinical decision making and proposed the adoption of an International Scale of measurement. The purpose of this review is to present the evidence and supporting data for specific recommendations. These recommendations include use of the same source of cells, either blood or marrow, for analysis; for validation of equal PCR amplification efficiencies of cDNA and standards when using a plasmid to construct standard curves and for ensuring ongoing high-level performance by undertaking a quality assurance programme. Clinicians must know the measurement reliability of an RQ-PCR assay to be able to determine the significance of a change in BCR-ABL level. An assay with poor precision limits the clinical usefulness of results. International harmonization should establish RQ-PCR measurement of BCR-ABL as the best method for monitoring treatment response for patients with CML.

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More information

Published date: 14 September 2006
Keywords: standards, rna, research, bcr-abl, pathology, chronic, humans, methods, proteins, australia, blood, review, protein, drug monitoring, therapy, bcr-abl positive, polymerase chain reaction, fusion proteins, messenger, leukemia, patients, reproducibility of results, research support, treatment, analysis, myelogenous, genetics, quality control, decision making

Identifiers

Local EPrints ID: 59517
URI: http://eprints.soton.ac.uk/id/eprint/59517
ISSN: 0887-6924
PURE UUID: 93483319-ea59-4b87-984f-e27903ffe57c
ORCID for N.C. Cross: ORCID iD orcid.org/0000-0001-5481-2555

Catalogue record

Date deposited: 03 Sep 2008
Last modified: 17 Dec 2019 01:51

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Contributors

Author: S. Branford
Author: N.C. Cross ORCID iD
Author: A. Hochhaus
Author: J. Radich
Author: G. Saglio
Author: J. Kaeda
Author: J. Goldman
Author: T. Hughes

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