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Interleukin-6(IL-6) testing kit(labelling immunoassay)
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Basic data
| Standard ID | YY/T 1916-2023 (YY/T1916-2023) |
| Description (Translated English) | Interleukin-6(IL-6) testing kit(labelling immunoassay) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 9,972 |
| Date of Issue | 2023-09-05 |
| Date of Implementation | 2024-09-15 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the requirements for interleukin-6 (hereinafter referred to as IL-6) determination kit (labeled immunoassay method), test methods and identification, labeling and instructions for use, packaging, transportation and storage. This standard is applicable to kits for the quantitative determination of IL-6 content in human serum, plasma or whole blood based on the reaction principle of labeled immunity. The methodologies include fluorescent labeling immunochromatography, chemiluminescence, etc. This document does not apply to the evaluation of IL-6 calibrators and quality controls. |
YY/T 1916-2023: Interleukin-6(IL-6) testing kit(labelling immunoassay)
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ICS 11.100
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Interleukin 6 (IL-6) Assay Kit
(labeled immunoassay)
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
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 be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Leadman Biochemical Co., Ltd., Chongqing Medical Device Quality Inspection Center, Beijing Medical Device Inspection
Laboratory Research Institute, Shenzhen New Industry Biomedical Engineering Co., Ltd., Zhengzhou Antu Bioengineering Co., Ltd., Nanjing Novozan Medical
Therapeutic Technology Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., and Zhonghan Shengtai Biotechnology Co., Ltd.
The main drafters of this document. Li Ran, Luo Chunmei, Liu Yanchun, Wang Wenfeng, Chen Jing, Wang Huiying, Su Jianchen, and Wang Zhong.
Interleukin 6 (IL-6) Assay Kit
(labeled immunoassay)
1 Scope
This document specifies the requirements, test methods and labeling of interleukin-6 (hereinafter referred to as "IL-6") assay kit (labeled immunoassay),
Labeling and instructions for use, packaging, transportation and storage requirements.
This document is applicable to kits for quantitative determination of IL-6 content in human serum, plasma or whole blood using labeled immunity as the reaction principle. Methodology
Including fluorescent labeling immunochromatography, chemiluminescence, etc.
This document does not apply to the evaluation of IL-6 calibrators and quality controls.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 191 Packaging, storage and transportation pictorial mark
GB/T 21415 Metrological traceability of measurement calibrators and control substance values assigned to biological samples for in vitro diagnostic medical devices
origin
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
There are no terms or definitions to be defined in this document.
4 requirements
4.1 Appearance
The appearance should meet the following requirements.
a) All components of the kit should be complete and complete, and there should be no leakage of liquids;
b) Packaging labels should be clear and easy to identify.
4.2 Traceability
The source, assignment process and measurement uncertainty of IL-6 calibrators should be provided in accordance with GB/T 21415 and relevant regulations.
4.3 Detection limit
The detection limit should be no higher than 3pg/mL.
4.4 Accuracy
The accuracy should meet one of the following requirements. If applicable, the relative deviation method is preferred.
...
