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Basic data
| Standard ID | YY/T 1731-2020 (YY/T1731-2020) |
| Description (Translated English) | (Human gene single nucleotide polymorphism (SNP) detection kit) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Word Count Estimation | 6,689 |
| Date of Issue | 2020-06-30 |
| Date of Implementation | 2021-06-01 |
| Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration |
| Issuing agency(ies) | State Drug Administration |
YY/T 1731-2020: (Human gene single nucleotide polymorphism (SNP) 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 gene single nucleotide polymorphism (SNP) detection kit)
ICS 11:040
C44
People's Republic of China Pharmaceutical Industry Standard
Human gene single nucleotide polymorphism (SNP) detection kit
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: Publication of this document
The agency is not responsible for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136):
Drafting organizations of this standard: Beijing Institute of Medical Device Inspection, China Food and Drug Control Research Institute, Sun Yat-sen University Daan Gene Co:, Ltd:
Company, Shandong Medical Device Product Quality Inspection Center:
The main drafters of this standard: Zhang Ligang, Zhao Yujie, Dai Leiying, Qu Shoufang, Gao Xunian, Liu Xiaoshuai:
Human gene single nucleotide polymorphism (SNP) detection kit
1 Scope
This standard specifies the requirements, test methods and labels, instructions for use, and packaging for human gene single nucleotide (SNP) polymorphism detection kits:
The contents of installation, transportation and storage:
This standard applies to the quality control of single nucleotide polymorphism (SNP) detection kits in human genes: Kit methodology includes real-time fluorescence
PCR method, PCR gene chip method, PCR electrophoresis method, PCR capillary electrophoresis analysis method, PCR high resolution melting curve method, flow fluorescence hybridization
Method, time-of-flight mass spectrometry, pyrosequencing method, Sanger sequencing method, etc:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Single nucleotide polymorphism singlenucleotidepolymorphisms; SNP
The difference of a single base sequence at the level of normal individual genome, including base conversion and transversion:
4 requirements
4:1 Appearance
The components of the kit should be complete and complete, no liquid leakage, and the signs and labels should be clear:
4:2 Reference product compliance
The test results of national reference materials and/or standardized corporate reference materials within the scope of the test kit should be consistent with known genotypes:
The setting of reference products should follow the following principles:
a) All genotypes detectable within the scope of the kit;
b) For common genotypes in reference products, genomic DNA extracted from clinical samples or cell lines should be used;
c) In the composition of reference products used, the matrix of all genotype reference products should be the same or similar to the actual test sample matrix:
4:3 Analysis specificity
When testing specific national reference materials and/or standardized corporate reference materials, the test result should be negative:
The setting of analysis-specific reference products should follow the following principles:
a) A certain number of non-human genome samples should be included: common microbial samples;
b) A certain number of genotypes or gene mutation samples that are closely related to the target gene and outside the scope of the kit design should be included:
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