YY/T 1847-2022Anti-human globulin test card (column agglutination technique) (English PDF)
抗人球蛋白检测卡（柱凝集法）
This is a limited preview
Buy now to download the full PDF (19 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1847-2022 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1847-2022 is the English-translated version of 抗人球蛋白检测卡（柱凝集法）.
YY/T 1847-2022 is the Chinese pharmaceutical industry standard for the anti-human globulin test card that works by column agglutination, the gel or glass bead microcolumn used for the Coombs test in immunohaematology.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, the requirements covering appearance, the specificity and sensitivity of the anti-IgG, anti-C3d and anti-IgG,C3d reagents, the absence of non-specific agglutination, repeatability and stability. Issued on 18 May 2022, it has applied since 1 June 2023.
Found what you need?
Document preview — YY/T 1847-2022
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
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.
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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1847-2022
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1847-2022
$150.00