Evaluation of clinical performance of the major BCR-ABL mRNA detection kit which enables conversion to international standard scale using the reference material calibrator.

Koichi Miyamura, Shinichiro Okamoto, Noriko Usui, Masayuki Hino, Koichi Akashi, Tomoaki Nakaseko, Naoto Takahashi, Kaname Nakatani, Keita Takahashi, Tsutomu Nobori, Tomoki Naoe

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Abstract

In a multicenter study, we evaluated the Major BCR-ABL mRNA/ABL mRNA quantification kit (M135R), which uses reference material included in the kit designed to report results using the international scale (IS). In total, 127 samples were studied. A good correlation was observed between M135R results and home-brew RT-qPCR results, which are reported on the IS using a conversion factor (r=0.90; n=115). However, the correlation coefficient between M135R results and Amp-CML results was relatively low (r=0.56; n=108). A good correlation was observed between M135R results from the two assay sites (r=0.94; n=115). The subset analysis of samples from the two assay sites showed M135R to have a good correlation even in the low IS range (r=0.98; IS≤1%). M135R showed high sensitivity and accuracy for detecting minimal residual disease and is considered to be a useful tool for treatment response assessment and for early detection of recurrence in CML patients.

Original languageEnglish
Pages (from-to)534-540
Number of pages7
Journal[Rinshō ketsueki] The Japanese journal of clinical hematology
Volume55
Issue number5
Publication statusPublished - 2014 May
Externally publishedYes

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ASJC Scopus subject areas

  • Medicine(all)

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