BACKGROUND: Real-time quantitative polymerase chain reaction (RQ-PCR) has been widely used for molecular monitoring for patients with chronic myeloid leukemia (CML). Currently, RQ-PCR is not based on the concept of international scale (IS) in Japan; mainly because none of the domestic laboratories have obtained their own conversion factor (CF) which makes it possible to convert locally scaled BCR-ABL (BCR-ABL (L)) value to the IS (BCR-ABL (IS)). To join the global trend of molecular assessment of BCR-ABL in CML patients, we have tried to obtain a CF in Japan. METHODS: Samples from 55 patients were exchanged between the Japanese laboratory and the reference laboratory in Adelaide, and BCR-ABL and internal control gene transcripts of the samples were measured using RQ-PCR. The patient bias conversion method was used to determine the CF for the IS using the Bland and Altman method. RESULTS: The local CF in the Japanese laboratory was determined to be 0.87. Based on this CF, 0.1% BCR-ABL (IS), defined as major molecular response, becomes equivalent to 731 copy/μg RNA BCR-ABL (L). CONCLUSION: This study is the first to introduce a laboratory-specific CF for harmonizing RQ-PCR methodology for detecting BCR-ABL transcripts to Japan, which may open new windows for molecular assessment of CML patients in Japan.
BACKGROUND: Real-time quantitative polymerase chain reaction (RQ-PCR) has been widely used for molecular monitoring for patients with chronic myeloid leukemia (CML). Currently, RQ-PCR is not based on the concept of international scale (IS) in Japan; mainly because none of the domestic laboratories have obtained their own conversion factor (CF) which makes it possible to convert locally scaled BCR-ABL (BCR-ABL (L)) value to the IS (BCR-ABL (IS)). To join the global trend of molecular assessment of BCR-ABL in CMLpatients, we have tried to obtain a CF in Japan. METHODS: Samples from 55 patients were exchanged between the Japanese laboratory and the reference laboratory in Adelaide, and BCR-ABL and internal control gene transcripts of the samples were measured using RQ-PCR. The patient bias conversion method was used to determine the CF for the IS using the Bland and Altman method. RESULTS: The local CF in the Japanese laboratory was determined to be 0.87. Based on this CF, 0.1% BCR-ABL (IS), defined as major molecular response, becomes equivalent to 731 copy/μg RNA BCR-ABL (L). CONCLUSION: This study is the first to introduce a laboratory-specific CF for harmonizing RQ-PCR methodology for detecting BCR-ABL transcripts to Japan, which may open new windows for molecular assessment of CMLpatients in Japan.
Authors: Timothy Hughes; Michael Deininger; Andreas Hochhaus; Susan Branford; Jerald Radich; Jaspal Kaeda; Michele Baccarani; Jorge Cortes; Nicholas C P Cross; Brian J Druker; Jean Gabert; David Grimwade; Rüdiger Hehlmann; Suzanne Kamel-Reid; Jeffrey H Lipton; Janina Longtine; Giovanni Martinelli; Giuseppe Saglio; Simona Soverini; Wendy Stock; John M Goldman Journal: Blood Date: 2006-03-07 Impact factor: 22.113
Authors: Tim P Hughes; Jaspal Kaeda; Susan Branford; Zbigniew Rudzki; Andreas Hochhaus; Martee L Hensley; Insa Gathmann; Ann E Bolton; Iris C van Hoomissen; John M Goldman; Jerald P Radich Journal: N Engl J Med Date: 2003-10-09 Impact factor: 91.245
Authors: Michele Baccarani; Jorge Cortes; Fabrizio Pane; Dietger Niederwieser; Giuseppe Saglio; Jane Apperley; Francisco Cervantes; Michael Deininger; Alois Gratwohl; François Guilhot; Andreas Hochhaus; Mary Horowitz; Timothy Hughes; Hagop Kantarjian; Richard Larson; Jerald Radich; Bengt Simonsson; Richard T Silver; John Goldman; Rudiger Hehlmann Journal: J Clin Oncol Date: 2009-11-02 Impact factor: 44.544