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Type: Journal article
Title: Validation of a rapid one-step high sensitivity real-time quantitative PCR system for detecting major BCR-ABL1 mRNA on an International Scale
Author: Yoshida, C.
Nakamae, H.
Fletcher, L.
Koga, D.
Sogabe, T.
Matsumura, I.
Kanakura, Y.
Branford, S.
Naoe, T.
Citation: SpringerPlus, 2016; 5(1):569-1-569-7
Publisher: Springer
Issue Date: 2016
ISSN: 2193-1801
Statement of
Chikashi Yoshida, Hirohisa Nakamae, Linda Fletcher, Daisuke Koga, Takayuki Sogabe, Itaru Matsumura, Yuzuru Kanakura, Susan Branford and Tomoki Naoe
Abstract: Background: Detection and quantitation of BCR-ABL1 transcripts are crucial for managing patients with chronic myeloid leukemia (CML). Although real-time quantitative polymerase chain reaction (RT-qPCR) can be measured on an International Scale (IS), this has not become fully universal. By using a WHO international standard panel established for calibrating secondary standards based on the IS, we have previously developed an RT-qPCR kit, ODK-1201, for quantification of major BCR-ABL1. Results: In this study, the reliability of kit-specific conversion factor 1.12 was validated by exchanging patients’ samples between three local clinical laboratories and a reference laboratory. The mean bias of the local method after IS conversion was 1.6 fold lower than the reference method. The clinically-useful sensitivity of the kit was further evaluated for monitoring patients with deep molecular response. Based on the correlation of the IS values between ODK-1201 and the reference laboratory method, the detection level of the kit was estimated as 0.0032 % BCR-ABL1 IS. Conclusions: ODK-1201 is a highly sensitive one-step RT-qPCR system for detecting BCR-ABL1 on the IS in 2 h after RNA extraction, thus contributing to standardization of molecular monitoring in CML.
Keywords: BCR-ABL1
Chronic myeloid leukemia
Conversion factor
International Scale
Real-time quantitative PCR
Rights: © The Author(s). 2016
DOI: 10.1186/s40064-016-2258-6
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