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Breakpoint cluster region - Abelson leukemia virus (BCR-ABL) fusion gene testing kit
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Basic data
| Standard ID | YY/T 1892-2024 (YY/T1892-2024) |
| Description (Translated English) | Breakpoint cluster region - Abelson leukemia virus (BCR-ABL) fusion gene testing kit |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100.10 |
| Word Count Estimation | 10,142 |
| Date of Issue | 2024-02-07 |
| Date of Implementation | 2025-03-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the requirements, labeling, instructions for use, packaging, transportation and storage of breakpoint cluster region-Abelsonian leukemia virus (BCR-ABL) fusion gene detection kits, and describes the corresponding test methods. This document is suitable for detecting breakpoint cluster area-Abelson leukemia virus (BCR-ABL) fusion gene detection kit in peripheral blood samples and bone marrow samples. The technical methods used include fluorescent polymerase chain reaction (Polymerase Chain Reaction, PCR) ) method, fluorescence reverse transcription-polymerase chain reaction (RT-PCR) method, reverse transcription digital polymerase chain reaction |
YY/T 1892-2024: Breakpoint cluster region - Abelson leukemia virus (BCR-ABL) fusion gene testing kit
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Breakpoint cluster region-Abelson leukemia virus
(BCR-ABL) Fusion Gene Detection Kit
gene testing kit
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Appearance 1
4.2 Nucleic acid extraction function 1
4.3 Requirements for quantitative reagents 2
4.4 Requirements for qualitative reagents 2
4.5 Stability 3
5 Test methods 3
5.1 Appearance 3
5.2 Nucleic acid extraction function 3
5.3 Quantitative reagents 3
5.4 Requirements for qualitative reagents 4
5.5 Stability 5
6 Labels and instructions for use 5
7 Packaging, transportation and storage 5
7.1 Packaging 5
7.2 Transportation 5
7.3 Storage 5
Appendix A (Informative) Molecular Response in Chronic Myeloid Leukemia 6
A.1 Fusion gene level 6
A.2 Molecular reactions 6
A.3 Molecular reactions and international standardized relationships 6
References 7
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. China Food and Drug Inspection Institute, Guangzhou Daan Gene Co., Ltd., Shanghai Ruiang Gene Technology Co., Ltd.
Co., Ltd., Jiangsu Medical Device Inspection Institute, Apbai Biotechnology (Suzhou) Co., Ltd., Suzhou Sinafu Medical Technology Co., Ltd., Xiamen
Menzhishan Biotechnology Co., Ltd., Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center),
Mygene Translational Medicine Research (Suzhou) Co., Ltd., Bio-Rad Biomedical Products (Shanghai) Co., Ltd., Suzhou Ruixun Biotechnology Co., Ltd.,
Beijing GenaMed Medical Technology Co., Ltd.
The main drafters of this document are. Qu Shoufang, Yang Yong, Tao Huiqing, Zhang Xiaoyan, Gong Jian, Wu Kun, Song Najie, Wang Ruixia, Wang Fangjie, Cao Shan, Dong Jia,
Ye Feng, Huang Taosheng, Xu Ren, Li Lili, Jia Zheng, Zhang Wenxin, Yu Ting, Sun Nan, Huang Jie.
Breakpoint cluster region-Abelson leukemia virus
(BCR-ABL) fusion gene detection kit
1 Scope
This document specifies the requirements, labeling, and test kits for the breakpoint cluster region-Abelson leukemia virus (BCR-ABL) fusion gene test.
and instructions for use, packaging, transportation and storage, and describes the corresponding test methods.
This document is applicable to the detection of breakpoint cluster region-Abelson leukemia virus (BCR-ABL) fusion in peripheral blood samples and bone marrow samples
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 191 Pictorial markings for packaging, storage and transportation
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Requirements
4.1 Appearance
The kit should meet the appearance requirements specified by the manufacturer. Appearance requirements include but are not limited to the following. the kit components are complete, the packaging
It should be clean, without leakage or damage; the signs and labels should be clear.
4.2 Nucleic acid extraction function
When applicable, the nucleic acid extraction function should meet the following requirements.
a) For kits containing nucleic acid extraction components, the manufacturer should make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function.
For example, fully consider the interference factors in the sample extraction process and the possible impact on the subsequent sample amplification process.
b) Samples that require extraction but do not contain nucleic acid extraction kits, the manufacturer's instructions or specified extraction kits, and verification
material.
c) For kits that can be directly amplified without sample extraction, the manufacturer should be able to provide sufficient evidence to prove the anti-interference ability of the enzyme in its product.
Disturbance.
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