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ABO reverse grouping reagents (Column agglutination technique, CAT)
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Basic data
| Standard ID | YY/T 1669-2019 (YY/T1669-2019) |
| Description (Translated English) | ABO reverse grouping reagents (Column agglutination technique, CAT) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 10,129 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-08-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the requirements, test methods, labels and instructions, packaging, transportation and storage of ABO reverse stereotype test card (column agglutination method). This standard applies to the use of gel, glass microbeads and other materials to fill the microcolumns, and the combination of immunohematology, particle sieving and centrifugation technology as the principle to carry out the clinical red blood cell ABO blood group system reverse typing diagnostic reagents. This standard does not apply to diagnostic reagents for blood source screening for reverse typing of the ABO blood group system. |
YY/T 1669-2019: ABO reverse grouping reagents (Column agglutination technique, CAT)
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ABO reverse grouping reagents (Column agglutination technique, CAT)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
ABO anti-type detection card
(column agglutination method)
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute, Changchun Bo Xun Biotechnology Co., Ltd., Shanghai Blood Biomedicine
limited liability company.
The main drafters of this standard. Shen Shu, Zhang Chuntao, Chen Weijia, Zhan Shenhong.
ABO anti-type detection card
(column agglutination method)
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 article.
Pieces. 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
YY/T 1669-2019
ABO reverse grouping reagents (Column agglutination technique, CAT)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
ABO anti-type detection card
(column agglutination method)
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute, Changchun Bo Xun Biotechnology Co., Ltd., Shanghai Blood Biomedicine
limited liability company.
The main drafters of this standard. Shen Shu, Zhang Chuntao, Chen Weijia, Zhan Shenhong.
ABO anti-type detection card
(column agglutination method)
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 article.
Pieces. 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
...
