YY/T 1669-2019ABO reverse grouping reagents (Column agglutination technique, CAT) (English PDF)
ABO反定型检测卡(柱凝集法)
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 24, 2019
Implementation date
August 1, 2020
Scope
YY/T 1669-2019 is the English-translated version of ABO反定型检测卡(柱凝集法).
YY/T 1669-2019 is the Chinese pharmaceutical industry standard for ABO reverse grouping reagents in column agglutination format, the gel or glass bead microcolumn cards with which the patient's serum is tested against known red cells.
It sets the requirements, the test methods, the labels and instructions and the rules for packaging, transport and storage, covering the appearance of the card, the specificity and the strength of the reactions, the absence of false results, the repeatability between cards and lots and the stability. Issued on 24 July 2019, it has applied since 1 August 2020.
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Document preview — YY/T 1669-2019
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements, test methods, labels and instructions, packaging, transportation and storage of the ABO anti-type test card (column agglutination method).
This standard applies to the use of gels, glass beads and other materials to fill the microcolumn, with immunohematology, particle sieving and centrifugation technology Based on the principle, a diagnostic reagent for the anti-type detection of the clinical red blood cell ABO blood group system is performed.
This standard does not apply to blood source screening for diagnostic reagents for the anti-type detection of the ABO blood group system.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents The Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Requirements
3.1 Appearance
The anti-shaped column should be colorless or yellowish; each column should be free of cracks, and there should be a liquid layer on the surface of the inner filling. The filling and liquid of each column should be No foreign matter; after centrifugation, there should be no air bubbles, and the surface of the filler should not be significantly inclined.
3.2 Specificity
3.2.1 Anti-shaped red blood cells in the anti-shaped column and ABO reverse-type blood group diagnostic reagent specific items with serum national reference or standard Serum (plasma) response Add the known A1 type anti-type reagent red blood cells, which should be positive with the above-mentioned B, O type serum (plasma), and the above A1, A1B type The serum (plasma) reaction is negative; the addition of the known type B anti-type reagent red blood cells should be positive with the above-mentioned A1 and O-type serum (plasma).
The reaction with the above B, A1B type serum (plasma) was negative. The positive reaction should not have a mixed reaction such as a double group phenomenon. Negative reaction should not have condensation Set, hemolysis, etc. are not easy to distinguish.
3.2.2 Reaction of anti-shaped red blood cells with monoclonal antibodies in a reverse-shaped column Add the known A1 type anti-type reagent red blood cells, which should be positively reacted with anti-A monoclonal antibody and react with anti-B monoclonal antibody.
Negative; add red blood cells of known type B anti-type reagent, should be positively reacted with anti-B monoclonal antibody, and react with anti-A monoclonal antibody Sex. The positive reaction should be 4, and there is no mixed reaction such as double group phenomenon. Negative reactions should not be difficult to distinguish between agglutination and hemolysis. Inverse The criterion for determining the agglutination strength of the column 4 shall be in accordance with the provisions of Appendix A.
3.2.3 Reaction of quality control experiments in a reversed column
If you do not need to add any serum (plasma), the red blood cell reaction should be negative for any type of reagent; if you need to add the serum to be tested (blood
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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
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YY/T 1669-2019
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