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YY/T 1962-2025: Aldosterone testing kit (Chemiluminescent immunoassay)
Status: Valid
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| YY/T 1962-2025 | English | 169 |
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Aldosterone testing kit (Chemiluminescent immunoassay)
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Standard similar to YY/T 1962-2025 YY/T 1713 | YY/T 1709 | YY/T 1721 | YY/T 1961 | YY/T 1958 | Basic data | Standard ID | YY/T 1962-2025 (YY/T1962-2025) | | Description (Translated English) | Aldosterone testing kit (Chemiluminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 8,819 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the technical requirements, labeling, instructions for use, packaging, transportation, and storage of aldosterone assay kits (chemiluminescent immunoassay), and describes the corresponding test methods. This document applies to kits for the quantitative determination of aldosterone in human serum or plasma based on the principle of chemiluminescent immunoassay. | YY/T 1962-2025: Aldosterone testing kit (Chemiluminescent immunoassay)---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
Aldosterone Assay Kit (Chemiluminescent Immunoassay)
Published on 2025-06-18
Implemented on July 1, 2025
National Medical Products Administration issued
Foreword
This document is in accordance with GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting is scheduled.
Please note that some content in this document may involve patents. This document is published.
The organization is not responsible 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. Beijing Tongren Hospital, Capital Medical University; National Center for Clinical Laboratories, National Health Commission; and Civil Aviation General Hospital.
Soling Diagnostics (Shanghai) Co., Ltd., Zhengzhou Antu Bioengineering Co., Ltd., and Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
The company, Shandong Boke Diagnostic Technology Co., Ltd., and Shenzhen Tailede Medical Co., Ltd.
The main drafters of this document are. Liu Xiangyi, Zhou Weiyan, Wang Xuejing, Shi Mengmeng, Li Bin, Liu Junjun, Xie Qinghua, and Wang Yu.
Aldosterone Assay Kit (Chemiluminescent Immunoassay)
1 Scope
This document specifies the technical requirements, labeling, instructions for use, and packaging for aldosterone assay kits (chemiluminescent immunoassay).
Transportation and storage, with corresponding test methods described.
This document applies to kits for the quantitative determination of aldosterone in human serum or plasma based on the principle of chemiluminescent immunoassay.
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 21415 Metrological Traceability of Calibrators and Control Substances for the Measurement of Quantities in Biological Samples of In Vitro Diagnostic Medical Devices
Source
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
This document does not contain any terms or definitions that need to be defined.
4 Requirements
4.1 Appearance
The appearance should meet the following requirements.
a) All components of the kit should be complete and intact, with no leakage of liquid;
b) The liquid components should be homogeneous and free of foreign matter;
c) Packaging labels should be clear, undamaged, and easily identifiable.
4.2 Traceability
Manufacturers shall provide information on the source, assignment process, and measurement uncertainty of the aldosterone calibrators used, in accordance with GB/T 21415 and relevant regulations.
Content such as degree.
4.3 Accuracy
Accuracy should meet one of the following requirements.
a) Relative bias. The sample is tested using a certified reference material or other recognized reference material that can be used to evaluate conventional methods.
The relative deviation of the measurement results should not exceed ±15%.
b) Recovery test. The recovery rate should be within the range of [85%, 115%];
c) Comparison test. Compare with commercially available kits or reference methods, within the sample concentration coverage range claimed by the manufacturer.
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