Standard No.:	YY/T 1892-2024
English Name:	Break point cluster region - Abelson leukemia virus(BCR-ABL)fusiongene testing kit
Chinese Name:	断裂点簇集区-艾贝尔逊白血病病毒（BCR-ABL）融合基因检测试剂盒
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2024-2-7
Implemented on:	2025-3-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	6500 words
Translation Price(USD):	195.0
Delivery:	via email in 1~3 business day

本文件规定了断裂点簇集区-艾贝尔逊白血病病毒（BCR-ABL）融合基因检测试剂盒的要求、标签和使用说明、包装、运输和贮存，描述了相应的试验方法。
本文件适用于检测外周血样本和骨髓样本的断裂点簇集区-艾贝尔逊白血病病毒（BCR-ABL）融合基因检测试剂盒，采用的技术方法有荧光聚合酶链反应（Polymerase Chain Reaction，PCR）法、荧光逆转录聚合酶链反应（Reverse Transcription-Polymerase Chain Reaction，RT-PCR）法、逆转录数字聚合酶链反应（Reverse Transcription- Digital Polymerase Chain Reaction，RT-dPCR）法和数字聚合酶反应（Digital Polymerase Chain Reaction, dPCR）法等。