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YY/T 1831-2021: Treponema pallidum antibodies detection kit (immunochromatographic method)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1831-2021 | English | 139 |
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Treponema pallidum antibodies detection kit (immunochromatographic method)
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YY/T 1831-2021
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Basic data | Standard ID | YY/T 1831-2021 (YY/T1831-2021) | | Description (Translated English) | Treponema pallidum antibodies detection kit (immunochromatographic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,712 | | Issuing agency(ies) | State Drug Administration | YY/T 1831-2021: Treponema pallidum antibodies detection kit (immunochromatographic method)---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.
Treponema pallidum antibodies detection kit (immunochromatographic method)
ICS 11:100:10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Treponema pallidum antibody detection kit (immunochromatography)
Published on 2021-12-06
2023-05-01 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 of Standardization Documents"
drafted:
Please note that some content of this document may be patented: Publication of this document
Institutions do not assume responsibility for identifying patents:
This document is proposed by the State Drug 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 is drafted by: China National Institute for Food and Drug Control, Shanghai Clinical Testing Center, Guangzhou Wanfu Biotechnology Co:, Ltd:
Company, Beijing Wantai Bio-Pharmaceutical Co:, Ltd:, Intech Innovation (Xiamen) Technology Co:, Ltd:, Aibo Bio-Pharmaceutical (Hangzhou) Co:, Ltd:
Company, Abbott Medical Diagnostics Co:, Ltd:
The main drafters of this document: Xia Deju, Wang Jinghua, Guan Lijing, Xian Yangling, Qin Rong, Wei Yunyun, Xiao Yingchun:
Treponema pallidum antibody detection kit (immunochromatography)
1 Scope
This document specifies the requirements, test methods, identification, labeling and instructions for use of Treponema pallidum antibody detection kits (immunochromatography):
Books, packaging, transportation and storage:
This document is suitable for the qualitative determination of Treponema pallidum antibodies in human serum, plasma or whole blood based on the principle of immunochromatography:
Treponema pallidum antibody detection kits such as body gold method and latex method:
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document:
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document:
4 Requirements
4:1 Appearance
The appearance should meet the following requirements:
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) Chinese packaging labels should be clear and free of wear:
4:2 Physical inspection
Physical inspection should meet the following requirements:
a) The width of the film strip should be greater than or equal to 2:5mm;
b) The liquid moving speed should be greater than or equal to 10mm/min:
4:3 Conformance rate of negative reference products
Use the national negative reference product for testing, the positive reaction should not be more than 2 copies, and the conformity rate (-/-) of the negative reference product should be greater than or equal to 18/
20; Or use a standardized negative reference substance for testing, and the results should meet the corresponding requirements:
Note: See Appendix A for the national negative reference product information involved in this document:
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