Early diagnosis method and diagnostic kit for liver cancer

A technology for early diagnosis and detection kits, applied in instruments, measuring devices, scientific instruments, etc., can solve the problems of low sensitivity of HCC, low sensitivity and specificity of liver cancer, etc., and achieve the effect of improving sensitivity

Inactive Publication Date: 2019-04-02
BEIJING EXELLON MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the most commonly used tumor marker for the early diagnosis of liver cancer is alpha-fetoprotein (AFP), which is widely used because of its relative specificity to HCC. However, AFP is positive in some benign liver diseases (specificity ≤ 75%) and AFP is negative in some liver cancers (sensitivity ≤ 70%), which makes it limited to rely solely on AFP for HCC early warning and monitoring, and the sensitivity of AFP detection for HCV-related HCC is not high
[0006] In addition to AFP, markers that can be used for the diagnosis of liver cance

Method used

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  • Early diagnosis method and diagnostic kit for liver cancer
  • Early diagnosis method and diagnostic kit for liver cancer
  • Early diagnosis method and diagnostic kit for liver cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 Detection of AFP\GP73\CEA\CA19-9\DCP\DKK1\TK1\AFU\ALT\TK1\γ-GT\Kininogen1

[0058] principle:

[0059] The detection of AFP is carried out in test strips using an enzymatic sandwich immunochemiluminescence technique. After the AFP antigen in the biological sample is incubated with the AFP monoclonal antibody coupled to the magnetic beads in the reaction well, an antigen-antibody complex is formed through an immune reaction. After magnetic separation and washing, complexes bound to the beads are attracted to the magnetic field, while unbound substances are washed away. The antigen-antibody complex was sucked into the reaction well containing the AFP monoclonal antibody labeled with horseradish peroxidase (HRP), and after incubation, the antibody-antigen-antibody sandwich complex was formed, and the unbound substances were separated by magnetic separation. rinse off. The sandwich complex reacts with the HRP catalytic luminescent substrate to generate a chemil...

Embodiment 2

[0097] Example 2 Detection of Fuc-Kininogen 1\AFP-L3\Fuc-GP73

[0098] principle:

[0099] Detection of Fuc-Kininogen 1 is carried out in test strips using an enzymatic sandwich immunochemiluminescence technique. After the total Kiininogen 1 antigen in the biological sample is incubated with the magnetic bead-coupled Kiininogen 1 monoclonal antibody in the reaction well, an antigen-antibody complex is formed through an immune reaction. After magnetic separation and washing, complexes bound to the beads are attracted to the magnetic field, while unbound substances are washed away. The antigen-antibody complex is sucked into the reaction well containing HRP-labeled lectin (LcA), and after incubation, the fucosylated Kininongen 1 antigen binds to LcA to form an antibody-fucosylated antigen-LcA sandwich complex, Unbound material is washed away after magnetic separation. The sandwich complex reacts with the HRP catalyzed luminescent substrate to generate chemiluminescent signal....

Embodiment 3

[0119] The detection of embodiment 3 ALP

[0120] principle:

[0121] The detection of ALP adopts the direct chemiluminescence method, the biological sample is mixed with the ALP catalytic luminescent substrate, and the chemiluminescent signal is generated through the direct enzyme-catalyzed reaction.

[0122] operate:

[0123] 1. Production of ALP test strips (see image 3 )

[0124] a) Hole 1 of the test strip is the sample injection hole;

[0125] b) The No. 2 hole of the test strip is the sample dilution hole;

[0126] c) 100 μL of ALP catalytic luminescent substrate was dried and stored in the No. 3 well.

[0127] 2. Detection of ALP blood samples

[0128] a) Add 10 μL of blood sample to well 1 of the test card strip.

[0129] b) Take 190 μL of blood sample diluent from well No. 2 and add it to well No. 1 to dilute the sample by 20 times.

[0130] c) Pipette 100 μL from the diluted sample into well No. 3, shake and mix well, incubate at 25° C. for 2 minutes, and t...

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Abstract

The invention provides an early diagnosis method of liver cancer for a subject, comprising the steps of: 1) obtaining a biological sample from the subject; 2) detecting the content of a plurality of biomarkers in the biological sample, wherein the plurality of biomarkers are selected from two or more of AFP, AFP-L3, GP73, Fuc-GP73, DCP, CEA, CA19-9, TK1, DKK1, [Gamma]-GT, ALP, AFU, ALT and Fuc-Kininogen 1; 3) calculating the probability that the subject has liver cancer based on the detection result of step 2); and 4) comparing the probability with a set threshold, and when the probability isgreater than or equal to the set threshold, the subject is considered to have liver cancer; when the probability is less than the set threshold, the subject is considered not to have liver cancer. Theinvention also provides a corresponding detection kit and a detection device. The early diagnosis method and the diagnostic kit of liver cancer improve the sensitivity and the specificity of early diagnosis of liver cancer by the combined detection of various markers, and provide a more reliable basis for clinical diagnosis of liver cancer.

Description

technical field [0001] The invention relates to a method for early diagnosis of liver cancer, especially a method for diagnosing liver cancer combined with multiprotein markers. The invention also relates to a kit and equipment for early diagnosis of liver cancer. Background technique [0002] Hepatocellular carcinoma (HCC) is one of the common clinical malignant tumors, and its main etiology is chronic liver virus infection of HCV or HBV. At present, there are about 20 million symptomatic chronic hepatitis B patients in China, and nearly 25% to 30% of chronic hepatitis B patients can develop into liver cirrhosis. Due to the large number of liver disease patients and high-risk groups of liver cancer, the incidence of liver cancer in China ranks first in the world. According to the 2015 WHO report, there were 782,000 new cases of liver cancer and 745,000 deaths worldwide. Among them, the number of new cases and deaths in China accounted for about 50%. [0003] Clinical tr...

Claims

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Application Information

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IPC IPC(8): G01N33/574
CPCG01N33/57438
Inventor 蒋健李昊蒲珏
Owner BEIJING EXELLON MEDICAL TECH CO LTD
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