Study on Standardization of Quantitative Detection Platform for BCR-ABL Fusion Gene as a Molecular Marker of Imatinib Mesylate
Objective:To evaluate performance of BCR-ABL fusion gene testing kit by digital PCR method using BCR-ABL quantitative standard.Methods:The RNA of standard was extracted and its concentration and purity was determined.The different BCR-ABL fusion gene testing kits(digital PCR method)and the digital PCR instrument were used for detection.The molecular response of BCR-ABL fusion gene was acquired for quantitative standard.Results:The MR absolute deviation of accuracy standards WS2 and WS3 did not exceed ±0.5 log.The detection limit standard WS4 could be detected positive mutation in the BCR-ABL fusion gene.The MR coeficient of variation(CV)of repeatability standards WS1 and WS4 was less than 3.0％.Conclusion:The performance indicators of accuracy,detection limit and repeatability of BCR-ABL fusion gene quantitative testing kits(digital PCR method)can all meet the requirements of Industry Standards for Breakpoint Cluster Region-Abelson Leukemia Virus(BCR-ABL)Fusion Gene Testing Kits,providing technical support for the implementation of the standard.
NETL
NSTL
万方数据
维普
