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Survival motor neuron gene (SMN) detection kit
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Basic data
| Standard ID | YY/T 1961-2025 (YY/T1961-2025) |
| Description (Translated English) | Survival motor neuron gene (SMN) detection kit |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100.10 |
| Word Count Estimation | 10,130 |
| 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, marking, labeling, and instructions for use of motor neuron survival gene (SMN) detection kits, as well as packaging, transportation, and storage, and describes the corresponding test methods. This document applies to detection kits established using the quantitative real-time PCR method, PCR-fluorescent probe method, fluorescent PCR-capillary electrophoresis method, and fluorescent PCR melting curve method. |
YY/T 1961-2025: Survival motor neuron gene (SMN) 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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Motor neuron survival gene (SMN) detection kit
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Requirements 1
5.Test Methods 3
6.Labeling, markings, and instructions for use 3
7 Packaging, transportation, and storage 3
Reference 5
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 Jiangsu Provincial Institute for Medical Device Testing.
Jingliang Technology (Shenzhen) Co., Ltd., Guangzhou Darui Biotechnology Co., Ltd., Yaneng Biotechnology (Shenzhen) Co., Ltd., Shenzhen Hui
Zhong Biotechnology Co., Ltd., Suzhou Tianlong Biotechnology Co., Ltd., Shanghai Wuseshi Medical Technology Co., Ltd., Jiangsu Shuoshi Biotechnology Co., Ltd.
Joint-stock limited companies, Beijing Yuewei Gene Technology Co., Ltd., and Xiamen Bio-Xun Biotechnology Co., Ltd.
The main drafters of this document are. Sun Nan, Xiang Jiale, Zhang Xiaoyan, Li Jinghua, Yang Xu, Lei Shuying, Yang Yongxian, Wang Xiaozhou, Li Mingyang, and Zhang Rong.
Wang Chunfang, Chen Qionge, Qu Shoufang, Yu Ting.
Motor neuron survival gene (SMN) detection kit
1 Scope
This document specifies the requirements, labeling, instructions for use, packaging, and transportation of motor neuron survival gene (SMN) detection kits.
The transport and storage methods are described, along with the corresponding experimental methods.
This document applies to quantitative real-time PCR, PCR-fluorescent probe method, fluorescent PCR-capillary electrophoresis, and fluorescent PCR melting curve.
The test kit was developed using [the method].
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
The protein is widely expressed in various tissues and cells, participates in the assembly of the spliceosome protein complex, and is an essential housekeeping protein for the survival of eukaryotic cells.
Note. Pathogenic mutations in the SMN1 biallelic gene usually lead to SMA; 95% of SMA patients are homozygous for exon 7 of the SMN1 gene.
The genotype-phenotype association is clear and missing.
3.2
The modifying gene for spinal muscular atrophy is located at 5q13.2 and encodes the same SMN protein as SMN1.
Note. SMN2 and SMN1 sequences are highly homologous, differing by only 5 bases, with the C/T at position 6 of exon 7 (c.840) causing 90% of the differences.
SMN2 mRNA exon 7 is selectively spliced, resulting in only 10% SMN2 expression of the full-length functional SMN protein. The patient carries copies of SMN2.
The more numbers, the lighter the phenotype.
3.3
SMN1-SMN2 gene conversion
4 Requirements
4.1 Appearance
Manufacturers should specify the appearance requirements for the kits.
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