Prostate gland specificity antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof

A prostate-specific and chemiluminescence technology, which is applied in the field of prostate-specific antigen chemiluminescence immunoassay quantitative assay kit and its preparation, can solve the problems of limited popularization and inability to be widely used in clinical diagnosis and scientific research, and achieve increased sensitivity Effect

Inactive Publication Date: 2009-03-04
北京科美东雅生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The chemiluminescence immunoassay kit in the prior art is a closed automatic chemiluminescence measurement system, which requires an expensive fully automatic chemiluminescence measuring instrument, thus limiting the popularization and use, and cannot be widely used in clinical diagnosis and scientific research

Method used

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  • Prostate gland specificity antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof
  • Prostate gland specificity antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof
  • Prostate gland specificity antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof

Examples

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Embodiment 1

[0044] Example 1 Preparation of the prostate-specific antigen chemiluminescent immunoassay quantitative assay kit of the present invention

[0045] 1. Preparation of alkaline phosphatase-labeled prostate-specific antigen monoclonal antibody

[0046] Prostate-specific antigen monoclonal antibody was coupled with alkaline phosphatase by the glutaraldehyde method, fully dialyzed against PBS, added with an equal volume of glycerol, and stored below -20°C.

[0047] 2. Selection of enzyme-labeled antibody concentration

[0048] Experiments have shown that the working concentration range of the enzyme-labeled antibody selected by the square array method is 1:500-50,000.

[0049] 3. Preparation of prostate-specific antigen calibrator

[0050] Calf serum is used as the matrix, and the purified human semen is serially diluted with the national standard product. A total of 6 bottles of calibrator with a concentration range of 0, 5, 10, 25, 50, and 100 ng / mL.

[0051] 4. Solid phase c...

Embodiment 2～3

[0093] Examples 2-3 Preparation of the prostate-specific antigen chemiluminescent immunoassay quantitative assay kit of the present invention

[0094] The PSA chemiluminescence immunoassay quantitative assay kit was prepared in the same manner as in Example 1 except that plastic beads and magnetic particles were used as carriers respectively.

Embodiment 4

[0095] Embodiment 4 The usage method of the kit of the present invention

[0096] Before using this kit for experiments, it is necessary to take out the solid-phase antibody, calibrator / test sample, and labeled antibody solution and place them at room temperature for 15 to 30 minutes to allow them to equilibrate to room temperature; after that, adjust the incubator or water bath to 37 ℃; and then, prepare a suitable micro-sampler and corresponding tips and check whether the chemiluminescence instrument and auxiliary instruments, such as a plate washer, are working normally.

[0097] The specific operation steps of using this kit to carry out the experiment according to the method of embodiment 1 are as follows:

[0098] 1) Place the strips required for the experiment (antibody-coated, 96 / 48 wells can be disassembled into 12 / 6*8*1 wells) on the plate rack;

[0099] 2) Add the sample to be tested and the calibrator of each concentration in the reaction well, add 0, 5, 10, 25, 5...

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Abstract

The invention relates to the medical field of immunoassay, more specially, the invention provides a chemiluminescent immunoassay detection kit for prostate specific antigens and a preparation method thereof. The kit of the invention comprises: 1) prostate specific antigen calibrators, 2) solid-phase vectors which are coated by prostate specific antigen monoclonal antibodies, 3) alkaline phosphatase which are marked anti-prostate specific antigen antibodies and 4) chemiluminescent substrate solution 1, 2-diarylethane derivative which is treated by the alkaline phosphatase. Further, the preparation method of the kit according to the invention comprises the following steps: 1) preparing the calibrators, 2) coating the solid-phase vectors with the prostate specific antigen monoclonal antibodies, 3) marking the anti-prostate specific antigen antibodies with the alkaline phosphatase, 4) packaging the calibrators, the enzyme markers and chemiluminescent substrate solutions and 5) assembling finished products. The kit of the invention has the advantages of convenience, rapidness, sensitivity, stability, and the like.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine, in particular, the invention provides a prostate specific antigen chemiluminescent immunoassay quantitative assay kit and a preparation method thereof. Background technique [0002] Prostate-specific antigen (PSA) is a single-chain glycoprotein molecule with a molecular weight of 30-33 kDa secreted by human prostate epithelial tissue cells. After PSA is secreted by the prostate, it first enters the semen and becomes an important protein component of the semen plasma, with a concentration of about 0.5-5 mg / mL. PSA is usually released into the blood of healthy men at low concentrations. In the human body, it mainly exists in male prostate tissue, semen and serum. Studies have shown that low concentrations of PSA can also be detected in female serum. [0003] PSA exists in the form of free PSA (free-PSA, f-PSA) in semen. After it enters the blood, it will combine with other protein molecules ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/543G01N21/76G01N33/88
Inventor 石根林金明王栩应希堂唐宝军胡国茂
Owner 北京科美东雅生物技术有限公司
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