YY/T 1591-2017 in English

VALID

Human epidermal growth factor receptor(EGFR) mutation detection kit

Issued on:2017-12-05
Implemented on:2018-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1591-2017
Document status:	VALID
Title in English:	Human epidermal growth factor receptor(EGFR) mutation detection kit
Title in Chinese:	人类EGFR基因突变检测试剂盒
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2017-12-05
Implemented on:	2018-12-01
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	human egfr gene mutation detection kit human epidermal growth factor receptor epidermal growth factor receptor gene mutation detection kits mutation detection
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本标准规定了人类表皮生长因子受体（Human Epidermal growth factor Receptor，EGFR）基因突变检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。
本标准适用于肿瘤组织或者细胞石蜡包埋切片、新鲜冰冻肿瘤组织提取的DNA样本中EGFR基因突变检测，外周血（浆）中EGFR基因突变检测可参照并制定符合外周血（浆）中EGFR基因突变检测所需的技术要求。
本标准适用于定性检测人类EGFR基因突变，采用的技术方法有荧光PCR法、流式荧光杂交法、荧光PCR熔解曲线法、焦磷酸测序法和Sanger测序法等。
本标准不适用于检测EGFR基因拷贝数变化的荧光原位杂交法；也不适用于检测EGFR基因突变的高通量测序法。

Scope

This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of human epidermal growth factor receptor (EGFR) gene mutation detection kits. This kit is suitable for qualitative detection of EGFR gene mutations. This kit is not suitable for detecting EGFR gene copy number changes. This kit is suitable for the detection of EGFR gene mutations in DNA samples extracted from tumor tissues or cell paraffin-embedded sections and fresh frozen tumor tissues. The detection of EGFR gene mutations in peripheral blood (plasma) can be referred to and formulated in accordance with the EGFR in peripheral blood (plasma) Technical requirements required for genetic mutation detection. This kit is suitable for human EGFR gene mutation detection kit. The technical methods used include fluorescence PCR method, flow fluorescence hybridization method, fluorescence PCR melting curve method, pyrosequencing method and Sanger sequencing method. This kit is not suitable for fluorescence in situ hybridization to detect EGFR gene copy number changes; this kit is not suitable for high-throughput sequencing methods to detect EGFR gene mutations.

More samples: DL/T 368-2010 DL/T 5154-2012 JGJ 94-2008

Sample only — not a preview of YY/T 1591-2017

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