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Detection kit for prostate specific antigen and preparation method thereof

A prostate-specific kit technology, applied in the field of immunoanalysis medicine, can solve the problems of uniformity and poor reproducibility of diagnostic kits, and achieve the effects of low cost, increased sensitivity, and improved sensitivity

Active Publication Date: 2012-12-12
乐普(北京)诊断技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Specifically, the present invention solves the problems of poor uniformity and reproducibility of diagnostic kits in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of the fPSA chemiluminescent diagnostic kit of the present invention

[0033] The fPSA diagnostic kit of the present invention comprises:

[0034] 1) 96-well or 48-well luminescent microplates pre-coated with anti-FITC antibody;

[0035] 2) FITC-labeled anti-PSA antibody;

[0036] 3) Anti-fPSA antibody labeled with horseradish peroxidase;

[0037] 4) Standard products with serial concentrations;

[0038] 5) The sample diluent is inactivated calf serum;

[0039] 6) The 20-fold concentrated washing solution is 0.02M phosphate buffered saline (PBS, pH=7.4) containing 0.05% Tween-20;

[0040]7) The chemiluminescent substrates A and B are luminol solution, hydrogen peroxide and special effect enhancer (p-iodophenol) solution respectively.

[0041] Prepare the above kit by the following method:

[0042] 1. Add anti-FITC antibody for coating to citrate buffer solution (pH=4.8) and mix well, add to wells of luminescent microplate, 100 μL per well, a...

Embodiment 2

[0065] Example 2 The method of using the kit of the present invention:

[0066] 1. Take out the kit from the refrigerator at 4°C, equilibrate at room temperature for 20 minutes, take a bottle of concentrated lotion, add distilled water (1ml+19ml) for later use.

[0067] 2. Take out the luminescence plate from the sealed bag, add 100 μL FITC-labeled anti-fPSA antibody solution (1:2000) to the microtiter plate coated with anti-FITC antibody, and incubate at 37°C for 1 hour.

[0068] 3. Discard the liquid in each well, fill each well with the washing solution, let it stand for 10-20 seconds, shake off the washing solution; repeat the plate washing, and finally pat dry on clean absorbent paper.

[0069] 4. Set 2 wells for each series of standard substance concentration, and 2 wells for each sample well. Take 50 μl of the standard substance or sample solution in the corresponding plate well, then add 50 μl of the enzyme marker, shake and mix well with a micro shaker, use no The ...

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PUM

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Abstract

The invention relates to the field of immunoassay medicine, and specifically provides a chemiluminescence immunoassay diagnostic kit for a free prostate specific antigen (fPSA) and a preparation method thereof. The kit provided by the invention comprises an anti-FITC antibody coated solid phase vector, an FITC marked anti-PSA antibody, an enzyme marked anti-fPSA antibody, a chemiluminescent substrate acted by the above enzyme, a negative control solution and a positive control solution. The preparation method of the above kit comprises the following steps: 1) coating a solid-phase vector with the anti-FITC antibody; 2) marking the anti-PSA antibody with FITC to obtain the FITC marked anti-PSA antibody; 3) marking the anti-PSA antibody with an enzyme to obtain the enzyme marked anti-fPSA antibody; and 4) subpackaging and assembling. The kit provided by the invention has low cost and high sensitivity, and can improve sensitivity and reproducibility of the assay and reduce the usage amount of antibodies compared with an existing chemiluminescence immunoassay detection method.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine, in particular, the invention provides a chemiluminescence immunoassay diagnostic kit for prostate specific antigen and a preparation method thereof. Background technique [0002] With the aging of the population, changes in dietary structure and environmental factors, and the improvement of medical care, the incidence of prostate cancer is increasing year by year, ranking third among male urinary and reproductive system malignancies. Prostate cancer generally has no obvious symptoms in the early stage. Once it is discovered, it often appears in the late stage, and the best time for treatment is missed. Therefore, sensitive early diagnosis methods are needed. [0003] Prostate-specific antigen (PSA, prostate specific antigen) is currently the most sensitive tumor marker for clinical diagnosis of prostate cancer. It has been recognized as an important indicator for the detection and evaluatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/573G01N33/543
Inventor 谢兵
Owner 乐普(北京)诊断技术股份有限公司