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Hepatitis C virus antibody detection kit, preparation method and detection method

A hepatitis C virus and antibody detection technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of low sensitivity and poor specificity, and achieve the effect of improving detection sensitivity and combining fully

Pending Publication Date: 2020-08-25
深圳市爱康试剂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the currently used chemiluminescent immunoassay for detecting hepatitis C antibodies still has problems such as low sensitivity and poor specificity.

Method used

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  • Hepatitis C virus antibody detection kit, preparation method and detection method
  • Hepatitis C virus antibody detection kit, preparation method and detection method
  • Hepatitis C virus antibody detection kit, preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] A hepatitis C virus antibody detection kit, including R1 reagent, R2 reagent, R3 reagent, calibrator and quality control product, wherein,

[0073] The R1 reagent includes a solution of streptavidin magnetic particles, the concentration of the streptavidin magnetic particles is 0.05-1 mg / ml, and the particle diameter of the magnetic particles is 1-4 μm.

[0074] R2 reagents include a mixed reagent of biotinylated hepatitis C virus antigen and hepatitis C virus recombinant antigen, the concentration of biotinylated hepatitis C virus antigen is 0.05-0.2%, and the concentration of hepatitis C virus recombinant antigen is 0.05-0.2% . Biotinylated hepatitis C virus antigen is obtained by tandem fusion expression of HCV Core, NS3, NS4, and NS5 gene fragments, and hepatitis C virus recombinant antigen is obtained by tandem fusion expression of HCV Core, NS3, NS4, and NS5 gene fragments. The hepatitis C virus antigen and the hepatitis C virus recombinant antigen bind to the he...

Embodiment 2

[0101] Detection method of hepatitis C virus antibody detection kit

[0102] Step A: Mix the sample to be tested with R2 reagent, incubate at 36-38°C, biotinylated hepatitis C virus antigen and hepatitis C virus recombinant antigen and hepatitis C virus antibody in the test object respectively to form "antigen- Antibody-antigen "sandwich complexes;

[0103] Step B: Add R1 reagent streptavidin-labeled magnetic particles and incubate at 36-38°C. The above-mentioned sandwich complex is bridged by the affinity between biotin and streptavidin, so that the complex is linked on the solid surface. phase carrier, wash;

[0104] Step C: adding R3 reagent alkaline phosphatase-labeled monoclonal antibody to hepatitis C virus, and washing;

[0105] Step B and step C are carried out sequentially, two-step washing;

[0106] Step D: Add the chemiluminescent substrate AMPPD to make it catalyzed by the enzyme to generate a luminescent signal, which is received by the optical quantum reading ...

Embodiment 3

[0108] Detection method of hepatitis C virus antibody detection kit

[0109] Step B and step C are carried out at the same time, adding R1 reagent streptavidin-labeled magnetic particles and R3 reagent alkaline phosphatase-labeled hepatitis C virus monoclonal antibody, incubating at 36-38°C, and washing in one step. All the other steps are the same as in Example 2.

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Abstract

The invention relates to the technical field of in-vitro diagnosis and detection, in particular to a hepatitis C virus antibody kit, a preparation method and a detection method. The hepatitis C virusantibody kit comprises a reagent R1, a reagent R2 and a reagent R3, and the reagent R1 comprises a streptavidin magnetic particle solution; the R2 reagent comprises a mixed reagent of a biotinylated hepatitis C virus antigen and a hepatitis C virus recombinant antigen; and the R3 reagent comprises an alkaline phosphatase labeled hepatitis C virus monoclonal antibody solution. According to the invention, the hepatitis C virus antibody, the biotinylated hepatitis C virus antigen and the hepatitis C virus recombinant antigen form a 'sandwich' sandwich compound, so that the blocking of antigen andantibody binding sites due to the addition of magnetic particles and enzyme markers is avoided, and the sensitivity and specificity of the detection of the hepatitis C virus antibody are remarkably improved.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnosis and detection, in particular to a kit, preparation method and detection method of hepatitis C virus antibody. Background technique [0002] Hepatitis C is a liver disease caused by hepatitis C virus (HCV). People of different genders, ages, and races are susceptible to HCV. The virus can cause acute or chronic hepatitis infection. According to WHO statistics, about 185 million people in the world are infected with HCV, and the infection rate is about 2.8%. HCV is occult, and the exact incidence of chronic hepatitis C is still unclear. The transmission routes of HCV mainly include: blood transmission, sexual transmission, mother-to-child transmission, and the transmission routes of some HCV-infected patients are not clear. [0003] An effective vaccine to prevent hepatitis C has not been successfully developed so far. Therefore, the effective way to prevent and treat hepatitis C is earl...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/543G01N33/535G01N33/577G01N21/76
CPCG01N33/56983G01N33/54326G01N33/535G01N33/577G01N21/76
Inventor 江伟敏曹志刚徐怀海张峰彭燕婷李兵古小丹彭迎春
Owner 深圳市爱康试剂有限公司
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