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YY/T 1882-2023: Treponema pallidum antibodies detection kit(Luminescence immunoassay)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1882-2023 | English | 159 |
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Treponema pallidum antibodies detection kit(Luminescence immunoassay)
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YY/T 1882-2023
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Basic data | Standard ID | YY/T 1882-2023 (YY/T1882-2023) | | Description (Translated English) | Treponema pallidum antibodies detection kit(Luminescence immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 8,865 | | Date of Issue | 2023-03-14 | | Date of Implementation | 2024-11-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of the Treponema pallidum antibody detection kit (luminescence immunoassay). This document is applicable to the qualitative detection of Treponema pallidum antibodies in human serum and/or plasma using chemiluminescence immunoassay, immunofluorescence assay, and time-resolved immunofluorescence assay based on the sandwich method or indirect method. | YY/T 1882-2023: Treponema pallidum antibodies detection kit(Luminescence 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.
ICS11:100:10
CCSC44
Pharmaceutical Industry Standard of the People's Republic of China
Treponema pallidum antibody detection kit
(luminescence immunoassay)
Released on 2023-03-14
2024-11-01 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136):
This document was drafted by: China National Institutes for Food and Drug Control, Zhengzhou Antu Bioengineering Co:, Ltd:, Kemei Diagnostics Technology Co:, Ltd:
Co:, Ltd:, Abbott Trading (Shanghai) Co:, Ltd:, Roche Diagnostic Products (Shanghai) Co:, Ltd:, Sysmex Medical Electronics (Shanghai) Co:, Ltd:
Division, Shenzhen New Industry Biomedical Engineering Co:, Ltd:
The main drafters of this document: Xia Deju, Wang Xinming, Wang Jianmei, Wu Xiaojun, Cai Xiaorong, Su Jing, Yuan Jinyun:
Treponema pallidum antibody detection kit
(luminescence immunoassay)
1 Scope
This document specifies the requirements, test methods, identification, labeling and use of the Treponema pallidum antibody detection kit (luminescence immunoassay)
Instructions, packaging, transportation and storage:
This standard applies to sandwich method or indirect method as the basic principle, using chemiluminescence immunoassay, immunofluorescence analysis, time analysis
Differential immunofluorescence analysis for the qualitative detection of Treponema pallidum antibodies in human serum and/or plasma:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 191 Packaging, storage and transportation icon marks
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2: In vitro diagnostic reagents for professional use
3 Terms and Definitions
This document does not have terms and definitions that need to be defined:
4 requirements
4:1 Appearance
Appearance should meet the following requirements:
a) The outer packaging should meet the requirements of the manufacturer;
b) The composition of the kit should be complete and meet the requirements of the manufacturer:
4:2 Conformity rate of negative reference product
Use the national negative reference product for testing, and the coincidence rate of the negative reference product should be ≥18/20; or use the standardized negative reference product for testing, and the result
The results should meet the corresponding requirements:
Note: See Appendix A for information on national negative reference products involved in this document:
4:3 Conformity rate of positive reference products
Use national positive reference materials for testing, and the coincidence rate of positive reference products should be ≥ 8/10; use or standardized positive reference materials for testing, and the results
The results should meet the corresponding requirements:
Note: See Appendix A for information on national positive reference products involved in this document:
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