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YY/T 1592-2018ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT) (English PDF)

ABO正定型和RhD血型定型检测卡（柱凝集法）

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 24, 2018

Implementation date

March 1, 2019

Scope

YY/T 1592-2018 is the English-translated version of ABO正定型和RhD血型定型检测卡（柱凝集法）.

YY/T 1592-2018 is the Chinese pharmaceutical industry standard for the ABO forward grouping and RhD typing test card in column agglutination format, the gel or glass bead microcolumn card used to type a patient's red cells.

It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance of the card, the specificity and strength of the reactions with the anti-A, anti-B and anti-D reagents, the absence of false results, the repeatability between cards and lots and the stability. Issued on 24 February 2018, it has applied since 1 March 2019.

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Document preview — YY/T 1592-2018

National Standard of the People's Republic of China

ICS: 11.040.30
Classification: C 30

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Requirements
4 Test method
5 Labels and instructions
6 Packaging, transportation and storage
Appendix A (normative appendix) ABO positive-type and RhD blood type stereotype test card (colum agglutination method) raw material data requirements
Appendix B (informative) A1 type, A2 type, B type, O type, RhD positive and RhD negative reagent red blood cell quality requirements Reference

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 for the ABO positive stereotype and RhD blood type stereotype test card (column agglutination method). Packaging, transportation and storage.

This standard applies to the use of gels, glass beads and other materials to fill the microcolumn, immunological hematology, particle sieving and centrifugation technology Based on the principle, positive identification of the clinical red blood cell ABO blood group system and detection of normal D antigen in the Rh system were performed.

This standard does not apply to blood source screening for diagnostic reagents for ABO positive typing and RhD blood type identification.

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

3 Requirements

3.1 Appearance

The anti-A column should be blue, the anti-B column should be yellow, and the anti-D column should be colorless or yellowish; each column should be free of cracks, and the surface of the inner filling should be There is a liquid layer, and there should be no impurities in the column packing and liquid; after centrifugation, there should be no air bubbles, and the surface of the filler should not be significantly inclined.

3.2 Specificity

Each column of the test card shall comply with the following regulations.

a) Anti-A column should be positively reacted with A1 type, A2 type, A2B type reagent red blood cells, and negative with B type and O type reagent red blood cells reaction.

b) Anti-B column should be positively reacted with B-type and A2B-type reagent red blood cells, and negative with A1 type, A2 type, O-type reagent red blood cells reaction.

c) Anti-D column should be positively reacted with normal RhD positive reagent red blood cells, and negative reaction with RhD negative reagent red blood cells.

d) All positive reactions should not have a mixed reaction such as a double group phenomenon. All negative reactions should not be difficult to distinguish by agglutination, hemolysis, etc.

Note 1. Normal RhD-positive red blood cells refer to RhD-positive red blood cells that do not include RhD antigen variants. The same below.

Note 2. The indistinguishable phenomenon of the negative reaction includes red blood cell tailing visible to the naked eye in the column.

3.3 Sensitivity

Each column of the test card shall comply with the following regulations.

a) When the anti-A column and the A1 type reagent red blood cells agglutinate, the reaction intensity should be not less than 4; with the A2 type and AB type reagent red When the cells undergo agglutination, the reaction intensity should be not less than 3.

b) When the anti-B column and the B-type reagent red blood cells agglutinate, the reaction intensity should be not less than 4; and the AB-type reagent red blood cells occur

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

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