Kit for comprehensively detecting four indexes of ovarian cancer through time-resolved fluorescence and application of kit

A time-resolved fluorescence and comprehensive detection technology, applied in the time-resolved fluorescence immunoassay kits of CEA and TPS, can solve the problems of very different judgment results, errors in detection results, and many detection steps. The effect of short time, improved specificity and sensitivity

Inactive Publication Date: 2014-02-12
河南生生医疗器械有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Conventional laboratories or medical units usually use a single kit for the detection of these four indicators, that is, one kit for the detection of one tumor marker. The disadvantages of this method are: 1. There are many detection steps, which are time-consuming and laborious; 2. , The four kinds of markers are detected by 4 kits respectively. Due to the differences in the kits o

Method used

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  • Kit for comprehensively detecting four indexes of ovarian cancer through time-resolved fluorescence and application of kit
  • Kit for comprehensively detecting four indexes of ovarian cancer through time-resolved fluorescence and application of kit
  • Kit for comprehensively detecting four indexes of ovarian cancer through time-resolved fluorescence and application of kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The kit provided in this example includes: an anti-HE4 antibody 9F3, an anti-CA125 antibody M32112M, an anti-CEA antibody MAM02-008, and an anti-TPS antibody 3A6. A mixed antibody-coated microwell plate composed of four monoclonal antibodies ; use Sm 3+ Labeled 10E1 antibody (anti-HE4 antibody), with Eu 3+ Labeled M86306M antibody (anti-CA125 antibody), with Tb 3+ Labeled MAM02-881 antibody (anti-CEA antibody), with Dy 3+ Labeled 4B9 antibody (anti-TPS antibody) mixed antibody composed of four monoclonal antibodies; analysis buffer; common fluorescence enhancer; washing solution; quality control composed of four standard mixtures of HE4, CA125, CEA, and TPS.

[0039] In the kit: the anti-HE4 monoclonal antibodies 9F3 and 10E1 antibodies and the anti-TPS monoclonal antibodies 3A6 and 4B9 were self-made by the inventor; the anti-CA125 monoclonal antibodies M32112M and M86306M antibodies and the anti-CEA monoclonal antibody MAM02 -008 and MAM02-881 antibodies were purch...

Embodiment 2

[0053] The application of the kit provided in Example 1 of the present invention in the comprehensive detection of four ovarian cancer tumor markers HE4, CA125, CEA, and TPS, that is, the kit provided in Example 1 of the present invention is used to comprehensively detect ovarian cancer tumor markers at the same time HE4, CA125, CEA, TPS time-resolved fluorescent immunoassay method, the reaction principle is as follows figure 1 As shown, the double-antibody sandwich method is used, including the following steps:

[0054] (1) Dilute the four protein standard mixtures of HE4, CA125, CEA, and TPS with the analysis buffer, that is, the quality control product, and make a mixed solution with a series of concentration gradients containing the four protein standards of HE4, CA125, CEA, and TPS ;

[0055] (2) Take 50 μl of the human serum to be tested and the mixed solution of the four protein standards prepared in step (1), and add them to different wells of the microwell plate coat...

Embodiment 3

[0057] Use the test kit of the present invention to detect the numerical values ​​of HE4, CA125, CEA, and TPS four indexes obtained by 40 serum samples and use the same 40 serum samples to test HE4 with the test kit of CanAg Company and test CA125 with the test kit of Roche Company respectively , Abbott's kit testing CEA, ID Biotech AB's kit testing TPS data obtained by regression correlation analysis, respectively, corresponding to the attached figure 2 , 3 , 4, 5, as can be seen from the accompanying drawings, each index data obtained by the test kit of the present invention has a good correlation with the data obtained by the test of the single index kit respectively.

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Abstract

The invention relates to the technical field of biological and medical detection, in particular relates to a time-resolved fluorescence immunodetection kit capable of simultaneously and comprehensively detecting four indexes of HE4, CA125, CEA and TPS in ovarian cancer tumor markers in a same reaction system, and also relates to application of the kit to comprehensive detection of the four indexes of HE4, CA125, CEA and TPS in the ovarian cancer tumor markers. The kit comprises a porous plate coated with a first monoclonal antibody mixture which resists the HE4, CA125, CEA and TPS respectively, an Sm<3+> labeled anti-HE4, Eu<3+> labeled anti-CA125, Tb<3+> labeled anti-CEA and Dy<3+> labeled anti-TPS second monoclonal antibody mixture, an analytical buffer solution, a common fluorescence enhancer, a cleaning solution and a quality control material. The kit provided according to the invention can be used for clinical auxiliary diagnosis, observation of curative effect and prognosis of ovarian cancer, has significance for treatment and prevention of the ovarian cancer tumor, and can be used for detecting the four tumor markers simultaneously, thus simplifying the detection steps and improving the specificity and sensitivity of comprehensive analysis of detected data.

Description

technical field [0001] The invention relates to the technical field of biological and medical detection, in particular to a time-resolved fluorescent immunoassay kit for simultaneously comprehensively detecting four indicators of ovarian cancer tumor markers HE4, CA125, CEA, and TPS in the same reaction system, and also relates to the The application of the kit in the comprehensive detection of four ovarian cancer tumor markers HE4, CA125, CEA, and TPS. Background technique [0002] Ovarian cancer has an insidious onset and poor prognosis, and is described as one of the deadliest cancers. The early symptoms of ovarian cancer are not obvious. The initial symptoms are abdominal pain or distension, and indigestion of the stomach. It is not easy to attract enough attention. Generally, ovarian cancer patients are discovered at an advanced stage, so the cure rate is extremely low. If ovarian cancer can be found in the early stage, the cure rate of ovarian cancer can be greatly im...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/577G01N33/543G01N33/533
CPCG01N33/533G01N33/57449G01N2800/36G01N2800/7028
Inventor 王嘎程自卿
Owner 河南生生医疗器械有限公司
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