Method, kit and system for verifying blood antibody valence detection capability

A blood group antibody and detection ability technology, applied in the field of blood group antibody titer detection ability verification methods, kits and systems, can solve the problem that cannot be used to evaluate the detection ability of immunohematology laboratories, and the agglutination intensity cannot be truly reflected and used for evaluation. Blood type antibody content and other issues to eliminate obvious damage and improve accuracy

CN109239364AInactive Publication Date: 2019-01-18SHANGHAI BLOOD CENT
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2019-01-18
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to a method, kit and system for verifying blood antibody valence detection capability. The method comprises the steps of delivering an IgG antibody sample with known standard valence, a quality control product and specification to a subject by an estimator; allowing the quality control IgG antibody and corresponding red blood cells to react to obtain a detection image by thesubject according to the specification, and comparing with a quality control image to eliminate the situation that the antibody sample is obviously damaged; detecting valence of the antibody sample bythe subject, delivering a material, a method and a result to the estimator; and comprehensively judging the obtained blood antibody valence detection capability of the subject by the estimator according to a reagent type which is used by the subject, a method type, the result and the standard valence of the IgG antibody sample. The kit comprises the IgG antibody sample, the quality control product and the specification. The system comprises the kit, an estimation end, an acceptance end and a verification platform. The method is beneficial for objectively and accurately estimating the blood antibody valence detection capability of immunohematology such as relevant laboratory or a person.
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Description

technical field

[0001] The invention relates to the field of blood detection, in particular to a method, kit and system for verifying the titer detection ability of blood group antibodies. Background technique

[0002] Immunohematology-related laboratories or professional technicians should have sufficient capabilities in blood group antibody titer testing to meet clinical or scientific research needs. At present, there is a lack of quality control products and methods on the market for evaluating the detection ability of blood group antibody titer. The existing similar quality control products are "external quality control products" issued by industries, organizations or laboratories, which are used for quality control of agglutination strength determination in blood group antibody detection. By distributing these samples to participating laboratories and recovering the test results of participating laboratories for analysis, the participating laboratories' ability to eval...

Examples

Embodiment 1

[0051] The nature of blood type antibody can be IgM type and IgG type, and the specificity of blood type antibody can be anti-A, anti-B, anti-D, etc. IgM blood type antibody, because there is no international standard product at present, can only be compared between laboratories and different methods at present. There are international standards for IgG antibodies, which can be compared quantitatively between laboratories. The method is to dilute the raw antibody and the international standard (Bristol International Blood Type Reference Laboratory) by 1.25 times, add the corresponding 2% red blood cell suspension, react and compare in the antiglobulin gel card, and obtain the The precise ratio of the antibody content of the antibody to the international standard. Due to the high titer of the raw antibody, it is usually necessary to quantitatively dilute to a lower concentration before comparing with the standard. Through comparison, the content of raw antibody can be calibra...

Embodiment 2

[0062] see Figure 4 , Figure 4 It is a flow chart of the blood group antibody titer detection ability verification method of the present invention. Include the following steps:

[0063] 1. The evaluator delivers the antibody samples, quality control materials, and instructions to the subjects. The antibody sample is an IgG antibody sample, and its standard titer is known to the evaluator; the quality control product includes a quality control IgG antibody with an agglutination strength of about 2+ (1+ to 3+), and The quality control picture of the quality control IgG antibody reacting with the corresponding erythrocytes at a concentration of 100% to 60%; the instruction manual records the operation method of the quality control product, which is the quality control IgG antibody An operating method that reacts with the corresponding red blood cells, the operating method has specific operating steps and parameters that are consistent with the steps and parameters used by th...

Embodiment 3

[0072] A blood type antibody titer testing proficiency testing kit, comprising:

[0073] Antibody sample: the standard titer of the antibody sample is known to the kit provider;

[0074] Quality control product: the quality control product includes a quality control IgG antibody with an agglutination intensity of about 2+ (1+~3+), and a quality control picture of the quality control IgG antibody reacting with the corresponding red blood cells at a concentration of 100%~60% ;

[0075] Instruction manual: The instruction manual records the operation method of the quality control product. The operation method of the quality control product is the operation method of reacting the quality control IgG antibody with the corresponding red blood cells. The operation method has specific operation steps and parameters, and the operation steps and parameters are the same as those obtained by the kit provider. The steps taken are consistent with the parameters.