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YY/T 1963-2025: Colorectal cancer related gene methylation detection kit (Fluorescent PCR)
Status: Valid
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| YY/T 1963-2025 | English | 159 |
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Colorectal cancer related gene methylation detection kit (Fluorescent PCR)
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Standard similar to YY/T 1963-2025 YY/T 1713 | YY/T 1709 | YY/T 1721 | YY/T 1961 | YY/T 1958 | Basic data | Standard ID | YY/T 1963-2025 (YY/T1963-2025) | | Description (Translated English) | Colorectal cancer related gene methylation detection kit (Fluorescent PCR) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 7,715 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the requirements, labeling, and instructions for use, as well as packaging, transportation, and storage, for colorectal cancer-related gene methylation detection kits, and describes the corresponding test methods. This document is applicable to the qualitative detection of colorectal cancer-related gene methylation status in peripheral blood plasma and fecal samples, such as Septin9, SDC2, BCAT1, SFRP2, TFPI2, NDRG4, and BMP3 genes. This document applies to kits using methods such as fluorescent PCR and PCR fluorescent probe methods, but not to kits using high-throughput sequencing methods. | YY/T 1963-2025: Colorectal cancer related gene methylation detection kit (Fluorescent PCR)---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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Colorectal cancer-related gene methylation detection kit
(Fluorescent PCR method)
(Fluorescent PCR)
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. China National Institutes for Food and Drug Control, BGI Genomics Co., Ltd., and Guangzhou Da An Gene Co., Ltd.
The company, Henan Provincial Institute for Drug and Medical Device Testing (Henan Provincial Vaccine Batch Release Center), Xiamen AmoyDx Biotechnology Co., Ltd., Guangzhou
Kangliming Biotechnology Co., Ltd., Bocheng (Beijing) Technology Co., Ltd., Shanghai TransGen Biotech Co., Ltd., Shanghai Kun
Yuan Health Technology Co., Ltd., Southern Medical University Southern Hospital, Shaanxi Provincial Institute for Food and Drug Control, Guangzhou Baochuang Biotechnology Co., Ltd.
company.
The main drafters of this document are. Qu Shoufang, Yu Jing, Jiang Xiwen, Zhang Juanli, Li Youcai, Li Meng, Liu Xingfeng, Guo Anliang, Liu Rui, Zheng Lei, and Cai Hu.
Pan Tengfei, Min Hong, Wang Yuying, Yuan Fuqiang, Yu Ting, Zhang Wenxin, Jia Zheng, Sun Nan, Li Lili, Huang Jie.
Colorectal cancer-related gene methylation detection kit
(Fluorescent PCR method)
1 Scope
This document specifies the requirements for colorectal cancer-related gene methylation detection kits, labeling and instructions for use, as well as packaging, transportation and storage.
The document describes the corresponding experimental methods.
This document is applicable to the qualitative detection of colorectal cancer-related gene methylation status in peripheral blood plasma and stool samples, such as Septin9.
Genes such as SDC2, BCAT1, SFRP2, TFPI2, NDRG4, and BMP3.
This document applies to kits for methods such as fluorescent PCR and PCR fluorescent probe methods, but not to kits for high-throughput sequencing.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 191 Pictorial Symbols for Packaging and Storage
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
DNA methylation
Under the catalysis of DNA methyltransferases, a methyl group is added to a base of a DNA molecule. The most common method is to...
A methyl group is added to the 5th carbon atom of the CpG dinucleotide cytosine to form 5-methylcytosine (5mC).
3.2
bisulfite conversion
DNA oxidative deamination was induced by bisulfite, converting unmethylated cytosine to uracil, while methylated cytosine remained unchanged.
constant.
4 Requirements
4.1 Appearance
The kit should meet the manufacturer's appearance requirements. All components of the kit should be complete and intact, with no liquid leakage.
4.2 Nucleic acid extraction function
The nucleic acid extraction function should meet the following requirements.
a) For kits containing nucleic acid extraction components, the manufacturer should specify appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function.
Evidence, such as fully considering interference factors present in the sample extraction process;
b) For kits that require sample extraction but do not contain nucleic acid extraction components, the manufacturer shall provide or specify the extraction kit and provide verification.
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