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YY/T 1586-2018: Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1586-2018	English	119	Add to Cart	3 days [Need to translate]	Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)

YY/T 1586-2018: Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)

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Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Tumor individualized treatment related gene mutation detection kit (fluorescence PCR method) (FluorescentPCR) Published on.2018-02-24 2019-03-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, Zhongshan University Daan Gene Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd. The main drafters of this standard. Zhang Ligang, Wang Ruixia, Gao Xunian, Cai Xiaorong, Deng Zhongping. Tumor individualized treatment related gene mutation detection kit (fluorescence PCR method)

1 Scope

This standard specifies the requirements, test methods, labels, instructions for use, and kits for the detection of gene mutation detection kits for individualized treatment of tumors. Loading, transport and storage. This standard applies to the nucleic acid detection technology of real-time fluorescent PCR method for gene mutation related to tumor individualized treatment. The types of gene mutations referred to in this standard include base substitution, transversion, insertion, deletion, and the like.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The components of the kit should be complete and complete, and the liquid should be free of leakage. 3.2 Positive coincidence rate Positive national reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding Variable type. The setting of positive reference products should follow the following principles. a) all types of mutations detectable within the scope of the kit; b) 3 mutation percentage gradients for each mutation site, weak positive reference. no more than 3 times the detection limit mutation rate; medium positive Reference product. mutation rate is not higher than 40%; strong positive reference product. mutation rate is not less than 70%; c) In the positive reference composition used, the matrix of the common mutation site reference should be the same or similar to the actual test sample matrix. 3.3 Negative compliance rate Test negative national reference products and/or standardized enterprise reference products, the test results should be negative or wild type. The setting of the negative reference should follow the following principles. a) should contain a certain number of non-human genome samples. common microbial samples; b) wild-type samples without corresponding target mutant sequences; c) Genotype or gene mutation samples outside the scope of the kit design. 3.4 Detection limit National reference products and/or standardized enterprise reference products within the scope of the test kit, the test results should be positive and consistent with the corresponding mutation ...