Naoto Takahashi
Nephrology, and Rheumatology,
1-1-1 Hondo, Akita City, Akita-010-8543
Japan
Research Article
Evaluating Sensitivity of ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit for Scoring Molecular Response
Author(s): Akiko Mita, Koichi Miyamura, Masayuki Hino, Kyoko Watakabe, Keita Takahashi, Michiko Yoshimoto and Naoto TakahashiAkiko Mita, Koichi Miyamura, Masayuki Hino, Kyoko Watakabe, Keita Takahashi, Michiko Yoshimoto and Naoto Takahashi
Objective: Tyrosine kinase inhibitors (TKIs) are the standard of care for patients with chronic myeloid leukemia (CML). Recent studies demonstrated that some patients with CML could sustain remission under discontinuation of TKIs. The clinical decision to discontinue such therapy depends on the patient’s molecular response (MR), derived from the international scale of BCR-ABL1 transcripts per internal control gene transcripts (BCR-ABL1IS), with MR4.5 (i.e., BCR-ABL1IS ≤0.0032%) commonly used as a threshold for discontinuation of TKI. However, it remains controversial whether all methods for determining BCR-ABL1IS have sufficient sensitivity for measuring MR4.5.
Methods: Probit analysis with reference to CLSI EP-17-A2 was used for the kit-specific limit of detection (LoD) of BCR-ABL1 transcripts measured by the ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit. In total, 50 sampl.. View More»
DOI:
10.4172/2155-9864.1000314