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Hepatitis C virus (HCV) antigen and antibody combined detection kit

A hepatitis C virus, antigen antibody technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inconvenient promotion and application of primary screening tests, high requirements for the experimental environment, and low degree of full automation, so as to achieve reliable detection results , improved sensitivity, and reproducible results

Inactive Publication Date: 2019-06-21
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the mainstream detection method is antibody detection, which is used as the primary screening reagent for the diagnosis of hepatitis C, but the window period of antibody detection is relatively long, usually 2-6 weeks
As a supplement to antibody detection, nucleic acid detection technology and core antigen detection are mainly used for retesting and confirmation of abnormal antibody detection samples, but they cannot be used as a primary screening test. For negative antibody detection, the actual window period samples may be missed, and the operation is cumbersome , has high requirements for the experimental environment, and it is not convenient to carry out clinical experiments
HCV antigen-antibody combined detection is a relatively new detection method with higher sensitivity than antibody detection. As a preliminary clinical screening reagent, it can basically make up for the shortcomings of the above-mentioned detection methods. However, there are relatively few such kits on the market at present, and It is mainly enzyme-linked immunoassay, which is not fully automated, and the operation is cumbersome, which is not convenient for clinical promotion and application as a primary screening test.

Method used

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  • Hepatitis C virus (HCV) antigen and antibody combined detection kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Example 1 Preparation of hepatitis C virus antigen antibody combined detection kit

[0012] 1. Preparation of magnetic particle coating

[0013] The process of connecting specific antigens and antibodies to magnetic beads by covalent coupling is called magnetic particle coating; the prepared magnetic particle antigen and magnetic particle antibody combination is called magnetic particle coating.

[0014] The basic principle of coating is: the amino groups on the surface of the antigen or antibody react with the chemical groups on the surface of the magnetic beads under the action of the chemical cross-linking agent to form a covalent combination of antigen / antibody-magnetic particles. The conjugate is washed and blocked to remove unreacted antigen or antibody, and block non-specific binding sites, and finally prepare the kit magnetic bead coating. The normal operation process is as follows:

[0015] 1. Take a solution of paramagnetic nanoparticles containing a certain function...

Embodiment 2

[0035] Example 2 Detection method of the kit of the present invention

[0036] The hepatitis C virus antigen antibody combined detection kit prepared in Example 1 is used in conjunction with the automatic chemiluminescence analyzer A2000 and A2000 Plus, and the process is as follows:

[0037] In the first step, add the sample, sample diluent and magnetic particle coating working solution to the reaction cup, and incubate at 37°C for 15 minutes. The HCV antibody in the sample and the HCV recombinant antigen coated with magnetic particles and the biotin in the sample diluent Antigen binding, the HCV core antigen in the sample is combined with the HCV core antigen monoclonal antibody coated with magnetic particles. After the incubation is completed, the solid phase is placed in a magnetic field and is attracted, and the substances bound to the solid phase are retained, while other Unbound material is removed by washing. The sample diluent and the magnetic particle coating working sol...

Embodiment 3

[0041] Example 3 Performance test of the kit of the present invention

[0042] HCV antibody national reference materials and WHO HCV core antigen standard materials were used to test the performance of antibody and antigen detection systems.

[0043] 1. Performance test of antibody detection system

[0044] The HCV antibody detection reagents were tested with the sixth set of national reference products. The positive coincidence rate was 29 / 30, and the negative coincidence rate was 30 / 30. The minimum detection limit reference samples L1-L3 were positive, L4 was negative, and the precision was 1.6%. Meet the requirements of national standards: positive compliance rate ≥29 / 30; negative compliance rate ≥29 / 30; the lowest detection limit reference product L1-L2 is positive, L4 is negative, L3 is positive or negative; precision reference product CV≤15 %. The test results are shown in Table 1:

[0045] Table 1: HCV antibody national panel test results

[0046]

[0047] 2. Performance test ...

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Abstract

The invention discloses a hepatitis C virus (HCV) antigen and antibody combined detection kit. The kit comprises magnetic particles, a sample diluent, a negative control, an antigen positive control,an antibody positive control and an enzyme conjugate, the magnetic particles are coated with recombinant HCV virus antigens and mouse anti-human HCV core antigen monoclonal antibodies; the antibody positive control contains HCV antibody positive human plasma; and the antigen positive control contains HCV recombinant core antigens. According to the kit, the chemiluminescence and magnetic particle separation technologies are combined, and the HCV recombinant core antigens and the HCV antibodies in serum are detected at the same time, by matching with a full-automatic chemiluminiscence instrumentof the Zhengzhou Antu Bio-Engineering Co.,Ltd, and can be used as a primary screening test for clinical detection, so that the window period is further shortened, and the HCV propagation is effectively controlled.

Description

Technical field [0001] The invention relates to antibody detection technology, in particular to a hepatitis C virus antigen antibody combined detection kit. Background technique [0002] Hepatitis C virus (hereinafter referred to as HCV) is a virus belonging to the hepatitis virus of the Flaviviridae family. It is a single-stranded positive-stranded RNA virus whose replication site is liver cells. The hepatitis C virus has spread to varying degrees in different regions of the world. According to statistics from the World Health Organization (WHO), approximately 170-200 million people worldwide are infected with HCV, the infection rate is as high as 3%, and 35,000 new infections are increasing every year. HCV infection has become one of the public health problems that seriously affect human health all over the world. At present, the main serum detection markers for hepatitis C are: hepatitis C virus antibody, hepatitis C virus core antigen and hepatitis C virus nucleic acid. Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/535G01N33/543G01N33/569
Inventor 刘旭王新明孙冯博刘功成付光宇吴学炜
Owner AUTOBIO DIAGNOSTICS CO LTD
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