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Incomplete antibody screening colloidal gold reagent kit and preparation method thereof

A complete antibody and colloidal gold technology, used in biological testing, material testing products, measuring devices, etc., can solve the problems of reduced red blood cell antigen activity, long detection time (more than 60 minutes, no more than 3 months, etc.) Scale operation, clear and easy to judge results, simple operation effect

Active Publication Date: 2015-04-29
INTEC PROD INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are many screening methods for irregular antibodies. Currently, the main detection methods on the market are: saline method, enzymatic method, anti-human globulin method, and microcolumn gel method. Most of the above methods have the disadvantages of long detection time and inconvenient operation. (Usually 37°C water bath for 30 minutes, then washed with normal saline for 3 times, and then centrifuged to observe
), because screening red blood cells are all used, and the reagents should be stored at 2-8°C. As the storage time prolongs, the activity of red blood cell antigens will decrease and hemolysis will occur, resulting in extremely unstable quality of screening red blood cell reagents, and the validity period not more than 3 months
In addition, there is a relatively similar method, which is the magnetic bead enzyme immunoassay method for blood group antibody screening. Freshly screened red blood cells are prepared into magnetized screening cell reagents. Incubate with alkaline phosphatase-labeled anti-human globulin, add substrate to develop color, and read the value with a microplate reader after termination to judge the result. The process needs to be washed at least 6 times and incubated 3 times, and the detection time is also longer (60 minutes) Above), the operation is complicated (requires repeated incubation and washing), and large-scale auxiliary equipment (microplate reader) is required. The reagents are composed of magnetized screening cell reagents, so they also need to be stored at 2-8 °C, and the validity period is usually not more than 3 month
The defects of the above detection methods greatly limit the application of these methods in actual clinical practice.

Method used

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  • Incomplete antibody screening colloidal gold reagent kit and preparation method thereof
  • Incomplete antibody screening colloidal gold reagent kit and preparation method thereof
  • Incomplete antibody screening colloidal gold reagent kit and preparation method thereof

Examples

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Effect test

Embodiment 1

[0042] A colloidal gold kit for erythrocyte antibody screening, the preparation method of the kit comprises the following steps:

[0043] (1) chloroauric acid is polymerized into colloidal gold particles with a size of 40 to 60 nm under the action of a reducing agent, and the reducing agent is at least one of sodium citrate, white phosphorus, ascorbic acid and tannic acid;

[0044] (2) Use monoclonal IgM antibody or polyclonal antibody to detect and identify healthy adult O red blood cells that are negative in the direct anti-human globulin test, and obtain common coverage of D, C, E, c, e, Jk a 、JK b , M, N, S, s, Fy a 、Fy b 、Di a , K, k, Le a 、Le b The first red blood cell, the second red blood cell and the third red blood cell of the P1 antigen, specifically the antigen spectrum of the first red blood cell is D, C, E, e, Jk a 、JK b , M, N, S, Fy a 、Di a , k, Le b and P1 antigen, the antigen spectrum of the second red blood cell is D, E, c, Jk a , M, s, Fy a , K,...

Embodiment 2

[0067] A colloidal gold kit for erythrocyte antibody screening, the kit is a dry kit, and its preparation method comprises the following steps:

[0068] (1) chloroauric acid is polymerized into colloidal gold particles with a size of 40 to 60 nm under the action of a reducing agent, and the reducing agent is at least one of sodium citrate, white phosphorus, ascorbic acid and tannic acid;

[0069] (2) Through the detection and identification of healthy adult O red blood cells negative in the direct anti-human globulin test by monoclonal IgM antibody or polyclonal antibody, the common coverage of D, C, E, c, e, Jk is obtained a 、JK b , M, N, S, s, Fy a 、Fy b 、Di a , K, k, Le a 、Le b The first red blood cell, the second red blood cell and the third red blood cell of the P1 antigen, specifically the antigen spectrum of the first red blood cell is D, C, E, e, Jk a 、JK b , M, N, S, Fy a 、Di a , k, Le b and P1 antigen, the antigen spectrum of the second red blood cell is D,...

Embodiment 3

[0095] Sensitivity test result of colloidal gold kit for screening red blood cell antibody of the present invention

[0096] Use the registered blood group monoclonal antibody (IgG) reagent to react with the colloidal gold particles containing the corresponding antigen in this kit (not limited to these antigens), and reach the following standards:

[0097] antiserum

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PUM

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Abstract

The invention discloses an incomplete antibody screening colloidal gold reagent kit and a preparation method thereof. The reagent kit comprises a first erythrocyte membrane antigen gold particle solution, a second erythrocyte membrane antigen gold particle solution, a third erythrocyte membrane antigen gold particle solution and an antihuman globulin solution, wherein an antigen spectrum of each of the first erythrocyte membrane antigen gold particle solution, the second erythrocyte membrane antigen gold particle solution and the third erythrocyte membrane antigen gold particle solution collectively include D, C, E, c, e, Jka, JKb, M, N, S, s, Fya, Fyb, Dia, K, k, Lea, Leb and P1 antigens. The reagent kit is long in storage time and easy to operate, the complicated process such as centrifuging, washing, and incubation is not needed, and a result is clear and easy to judge. The reagent kit also has the advantage of being suitable for large-scale operation and standard operation.

Description

technical field [0001] The invention belongs to the technical field of antibody detection, and in particular relates to an incomplete antibody screening colloidal gold kit and a preparation method thereof. Background technique [0002] With the development of blood transfusion technology, the incidence of immediate hemolytic reaction caused by wrong identification of ABO blood group has been significantly reduced, while delayed hemolytic reaction caused by immune antibody produced by blood transfusion or pregnancy immunization still occurs from time to time. In order to ensure the safety of clinical blood transfusion of patients, antibody screening is required before blood transfusion, so as to detect incomplete antibodies with clinical significance, which is of great significance for clinical safety of blood transfusion. [0003] Clinical significance of incomplete antibody screening: Although the detection rate of irregular antibodies in normal population is 0.3% to 2%, it...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/531G01N33/80
CPCG01N33/531G01N33/588G01N33/80
Inventor 胡晶高汪大明
Owner INTEC PROD INC
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