Evaluation of clinical performance of the Major <i>BCR-ABL</i> mRNA detection kit which enables conversion to international standard scale using the reference material calibrator

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  • キャリブレーターによる国際標準値変換を可能とするMajor <i>BCR-ABL</i> mRNA測定キットの臨床性能評価
  • 臨床研究 キャリブレーターによる国際標準値変換を可能とするMajor BCR-ABL mRNA測定キットの臨床性能評価
  • リンショウ ケンキュウ キャリブレーター ニ ヨル コクサイ ヒョウジュンチ ヘンカン オ カノウ ト スル Major BCR-ABL mRNA ソクテイ キット ノ リンショウ セイノウ ヒョウカ

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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.

Journal

  • Rinsho Ketsueki

    Rinsho Ketsueki 55 (5), 534-540, 2014

    The Japanese Society of Hematology

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