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YY/T 1591-2017: Human epidermal growth factor receptor(EGFR) mutation detection kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1591-2017 | English | 199 |
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Human epidermal growth factor receptor(EGFR) mutation detection kit
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YY/T 1591-2017
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Basic data | Standard ID | YY/T 1591-2017 (YY/T1591-2017) | | Description (Translated English) | Human epidermal growth factor receptor(EGFR) mutation detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,168 | | Date of Issue | 2017-12-05 | | Date of Implementation | 2018-12-01 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1591-2017: Human epidermal growth factor receptor(EGFR) mutation detection 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.
Human epidermal growth factor receptor (EGFR) mutation detection kit
ICS 11.040.30
C30
People's Republic of China pharmaceutical industry standards
Human EGFR gene mutation detection kit
2017-12-05 Published
2018-12-01 implementation
State Food and Drug Administration released
Directory
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Requirements 1
4 test methods 2
5 labels and instructions 2
6 packaging, transportation, storage 3
Reference 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard drafting unit. China Institute of Food and Drug Control, Fujian Province Medical Devices and Pharmaceutical Packaging Materials Inspection Institute, Zhongshan University
On Gene Co., Ltd., Wuhan Youzhi You Medical Technology Co., Ltd.
The main drafters of this standard. Qu Shou Fang, Yu Ting, noble first, Zheng Jingfeng, Gao Xuelian, Cai Congli.
Human EGFR gene mutation detection kit
1 Scope
This standard specifies the human epidermal growth factor receptor (HumanepidermalgrowthfactorReceptor, EGFR) gene
Variable test kit requirements, test methods, labeling and instruction manual, packaging, transportation and storage.
This kit is suitable for qualitative detection of EGFR gene mutations. This kit is not suitable for detection of EGFR gene copy number changes.
This kit is suitable for tumor tissue or cell paraffin-embedded sections, DNA samples extracted from fresh frozen tumor tissue EGFR
Gene mutation detection, peripheral blood (plasma) EGFR gene mutation detection can refer to and develop in line with the peripheral blood (plasma) EGFR gene mutation test
Test the required technical requirements.
This kit is suitable for human EGFR gene mutation detection kit, using the methods of fluorescence PCR, flow-fluorescent hybridization
Method, fluorescent PCR melting curve method, pyrosequencing method and Sanger sequencing method and the like. This kit is not suitable for detecting EGFR gene copies
Fluorescence in situ hybridization; This kit is not suitable for high-throughput sequencing of EGFR gene mutations.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
3 requirements
3.1 appearance
Manufacturers should be based on the packaging characteristics of their products to provide the appropriate appearance requirements. The kit should generally be composed of components, traits, both inside and outside
Packaging, labeling and other requirements of clarity.
3.2 Accuracy
Test kit detection range Human EGFR gene mutation national reference or a standardized enterprise reference, the result should be positive for mutation
And the type is accurate.
The standardized enterprise reference should meet the following requirements.
a) Types of mutations that should include not less than the national reference;
b) Mutation reference materials with different mutation ratios should be set reasonably;
c) other types of mutations should be set reasonable detection mutation type;
d) Reference materials for reproducibility assessment should be set reasonably, taking into account different mutation ratios and the application of wild type samples;
e) A reasonable method should be used to determine the mutation ratio of the limit of detection reference.
3.3 Specificity
3.3.1 Detection of Human EGFR Wild-type National Reference and Non-Human Genome Samples, Results Should Be Wild or Not Detected.
3.3.2 Detection kit outside the scope of human EGFR mutations of different types of national reference or standardized reference, the result should be
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