YY/T 1591-2017Human epidermal growth factor receptor(EGFR) mutation detection kit (English PDF)
人类EGFR基因突变检测试剂盒
This is a limited preview
Buy now to download the full PDF (25 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1591-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 5, 2017
Implementation date
December 1, 2018
Scope
YY/T 1591-2017 is the English-translated version of 人类EGFR基因突变检测试剂盒.
YY/T 1591-2017 is the Chinese pharmaceutical industry standard for kits that detect mutations of the epidermal growth factor receptor (EGFR) gene, the test on which treatment with EGFR inhibitors is decided.
It sets the requirements, the test methods, the labelling and instruction manual and the rules for packaging, transport and storage, covering the mutations to be detected, the detection limit in terms of mutant fraction and DNA input, the specificity, the accuracy against reference materials, the repeatability and the stability.
It is for the qualitative detection of mutations, not for changes in gene copy number. Issued on 5 December 2017, it has applied since 1 December 2018.
Found what you need?
Document preview — YY/T 1591-2017
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
- 4 test methods
- 5 labels and instructions
- 6 packaging, transportation, storage
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1591-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 1591-2017
$145.00