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YY/T 1847-2022: Anti-human globulin reagents(column agglutination technique, CAT)
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| YY/T 1847-2022 | English | 239 |
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Anti-human globulin reagents(column agglutination technique, CAT)
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YY/T 1847-2022
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Basic data | Standard ID | YY/T 1847-2022 (YY/T1847-2022) | | Description (Translated English) | Anti-human globulin reagents(column agglutination technique, CAT) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 11,111 | | Issuing agency(ies) | State Drug Administration | YY/T 1847-2022: Anti-human globulin reagents(column agglutination technique, CAT)---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.
Anti-human globulin reagents (column agglutination technique, CAT)
ICS 11.100.10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Anti-human globulin detection card (column agglutination method)
Published on 2022-05-18
2023-06-01 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, Beijing Medical Device Inspection Institute, Changchun Boxun Biotechnology Co., Ltd.
Company, Biole Life Medical Products (Shanghai) Co., Ltd., Shanghai Blood Biopharmaceutical Co., Ltd.
The main drafters of this document. Hu Zebin, Huang Jie, Bi Chunlei, Chen Weijia, Hou Lei, Zhan Shenhong.
Anti-human globulin detection card (column agglutination method)
1 Scope
This document specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage of anti-human globulin test cards (column agglutination method).
Save and so on.
This document applies to microcolumns filled with materials such as gels and glass beads, using immunohematology, particle sieving and centrifugation techniques.
Based on the principle of combination, the anti-human globulin detection reagents for qualitative detection include anti-IgG, anti-C3d, and anti-IgG C3d.
This document does not apply to diagnostic reagents for anti-human globulin detection in blood-based screening.
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 191-2008 Graphical signs of packaging, storage and transportation
GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2.In vitro diagnostics for professional use
break reagent
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of the product. Generally, there should be the composition and properties of each component of the reagent; internal and external packaging,
Requirements for clear labels, etc.
4.2 Specificity
4.2.1 Specificity of anti-IgG
4.2.1.1 General
Manufacturers should select IgG antibodies including but not limited to the following three systems, namely, anti-D antibodies of Rh system, and anti-D antibodies of Kidd system.
Anti-Jka/Jkb antibody and anti-Fya/Fyb antibody of Duffy system, using RhD positive and negative red blood cells, Jka/Jkb positive and negative red blood cells
Cells, Fya/Fyb positive and negative red blood cells, and the anti-human globulin test card to be tested for indirect anti-human globulin test and direct anti-human globulin test
white test.
NOTE. See Appendix A for information on red blood cells used in the assays involved in this document.
4.2.1.2 Indirect antiglobulin test
IgG type anti-D antibody, anti-Jka/Jkb antibody, anti-Fya/Fyb antibody react with the corresponding antigen-positive red blood cells in the detection card, and the result is
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