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Direct antiglobulin testing capability verifying method and testing kit thereof

A technology for proficiency verification and detection capabilities, applied in biological testing, material inspection products, measuring devices, etc., can solve problems that cannot be used to evaluate direct resistance detection capabilities

Inactive Publication Date: 2019-03-29
SHANGHAI BLOOD CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of the above quality controls can be used to evaluate the laboratory's ability to directly resist detection
In the prior art, there is no report about the direct resistance detection proficiency verification method of the present invention and its detection kit.

Method used

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  • Direct antiglobulin testing capability verifying method and testing kit thereof
  • Direct antiglobulin testing capability verifying method and testing kit thereof
  • Direct antiglobulin testing capability verifying method and testing kit thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Preparation of different direct resistance positive proficiency test products: use direct resistance negative, fresh, multi-person mixed red blood cells with a certain concentration, add a series of IgG blood type antibodies with a certain concentration, and prepare 3 to 12 different direct resistance strengths of test red blood cells. Since the concentration of red blood cells is known, the amount of IgG antibody added is known. Through calculation, the average number of IgG antibodies on each red blood cell can be obtained in direct anti-positive samples with different intensities. Through the proficiency testing product composed of a series of test products with known direct anti-positive strength and several direct anti-negative "interference items", the relative quantitative evaluation of the ability of the participating laboratories to detect direct anti-positive can be carried out, and can be performed in The test results of different times are compared to fin...

Embodiment 2

[0042] see Figure 7 , Figure 7 It is a flow chart of the direct resistance detection ability verification method of the present invention. Include the following steps:

[0043] 1. First, prepare different direct-resistance positive proficiency test products or mixed agglutination direct-resistance positive proficiency test products.

[0044] The preparation method of the different direct-antibody-positive proficiency test products is as follows: use direct-antibody-negative, fresh, mixed red blood cells with a certain concentration, add a series of IgG blood-type antibodies with a certain concentration, and prepare 3 to 12 different direct-antibody antibodies. Intensity of test red blood cells, according to the concentration of red blood cells and the amount of IgG antibody added, determine the average number of IgG antibodies on a single red blood cell in each blood group antibody, the above-mentioned series of test red blood cells with different direct positive strengths...

Embodiment 3

[0050] A proficiency testing kit for direct resistance detection, comprising: (1) detection proficiency testing products, including different direct resistance positive proficiency testing products or mixed agglutination direct resistance positive proficiency testing products; the different direct resistance positive proficiency testing products are a group It consists of red blood cell test samples with different direct resistance positive strengths and direct resistance negative red blood cell test samples. The direct resistance positive strength refers to the number of IgG antibodies on a single red blood cell in the sample, and the number of IgG antibodies on a single red blood cell ranges from 4 to 560 The mixed agglutination direct anti-positive proficiency verification product is a group of red blood cell test samples mixed with direct anti-positive red blood cells and direct anti-negative red blood cells in different proportions, and the ratio range is 0.2-8%; (2) Instru...

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Abstract

The invention relates to the field of blood testing, and particularly to a direct antiglobulin testing capability verifying method and a testing kit thereof. The method comprises the steps of a), delivering different direct antiglobulin positive capability verifying products or mixed aggregation direct antiglobulin positive capability verifying products, and a specification to a subject by an evaluator; b), receiving the capability verifying product and the specification by the subject, testing according to an antiglobulin method, recording a use material, a method and a result, performing feedback of the material, the method and the result together with a testing result to the evaluator; and c), performing comprehensive analysis of a feedback result by the evaluator, and accurately evaluating the antiglobulin testing capability of the subject. The capability verifying product can be used for verifying the direct antiglobulin testing capability of immunohematology laboratory or professional and technical personnel and can verify whether a professional laboratory satisfies a quality system requirement at an antiglobulin testing capability, and supplies an effective evaluating tool.

Description

technical field [0001] The invention relates to the field of blood detection, in particular to a method for verifying direct resistance detection ability and a detection kit thereof. Background technique [0002] Antihuman globulin test, also known as Coombs' test, is a common method for checking incomplete antibodies and is the most important test for diagnosing autoimmune hemolytic anemia. Generally divided into direct test (direct response) and indirect test (indirect response). The purpose of the anti-human globulin test (direct method) is to check the incomplete antibodies on the surface of red blood cells, and the purpose of the anti-human globulin test (indirect method) is to check whether there are free incomplete antibodies in the serum. The erythrocytes with the corresponding antigen on the surface combined with the incomplete antibody are called sensitized erythrocytes, and the sensitized erythrocytes washed with saline do not agglutinate in saline medium, but ag...

Claims

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Application Information

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IPC IPC(8): G01N33/80G01N33/68
CPCG01N33/6854G01N33/80
Inventor 向东金沙沈伟
Owner SHANGHAI BLOOD CENT
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