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Harmless Positive Control for Hepatitis C ELISA

A positive control and immunodiagnostic technology, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as lack of vaccines

Inactive Publication Date: 2016-08-24
XINXIANG MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

HCV cannot be cultivated by conventional methods at present, and there is no vaccine or specific drug, so prevention is the main way to control its epidemic

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Harmless positive control for hepatitis C enzyme-linked immunoassay diagnosis

[0029] 1. Obtaining mouse anti-HCV monoclonal antibodies

[0030] Use HCV virus genetic engineering antigen (containing protein encoded by HCV virus Core, NS3, NS4, NS5, E2, etc.) as immune antigen to immunize BALB / c mice, and fuse spleen lymphocytes of immunized mice with myeloma cells , And then use the limiting dilution method to obtain hybridomas that can secrete red blood cell monoclonal antibodies. Specific steps are as follows:

[0031] Take 0.2mg / ml HCV virus genetic engineering antigen, and use subcutaneous multi-point injection for the first immunization, 0.1ml / point, a total of four points. The second immunization after 2 weeks, the same dose as above, intraperitoneal injection. After another 2 weeks, the third immunization, the same dose as above, intraperitoneal injection (5-7 days later, blood samples are taken to measure the titer). After another 2 to 3 weeks, the immun...

Embodiment 2

[0042] Example 2 Hepatitis C Indirect Enzyme Immunodiagnosis Kit

[0043] The harmless positive control obtained in Example 1 was used to prepare a hepatitis C indirect method enzyme immunodiagnosis kit, the composition is as follows:

[0044] Kit composition

48-hole configuration

96-well configuration

save

Manual

1 serving

1 serving

Sealing film

2 slices (48)

2 slices (96)

sealed bag

1 piece

1 piece

Enzyme-labeled coated plate

1×48

1×96

Store at 2-8℃

Negative control

0.5ml×1 bottle

0.5ml×1 bottle

Store at 2-8℃

Positive control

0.5ml×1 bottle

0.5ml×1 bottle

Store at 2-8℃

Enzyme reagent

3ml×1 bottle

6ml×1 bottle

Store at 2-8℃

Sample diluent

3ml×1 bottle

6ml×1 bottle

Store at 2-8℃

Chromogenic agent A liquid

3ml×1 bottle

6ml×1 bottle

Store at 2-8℃

Chromogenic agent B liquid

3ml×1 bottle

6ml×1 bottle

Store at 2-8℃

Stop solution

3ml×1 bottle

6ml×1 bottle

Store at 2-8℃

Concentrated washing liquid

(20ml×20 times)×1 bottle

(20ml×...

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PUM

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Abstract

The invention relates to an enzyme-linked immunosorbent kit, and particularly provides harmless positive control for enzyme-linked immune diagnosis of hepatitis c. The positive control is prepared by an anti-mouse HCV antibody and an anti-mouse IgG antibody in the ratio of (2 to1) to (1 to 32) in a mixing manner. According to the immunology method, the problem of source of a positive control material for enzyme-linked immune diagnosis of the hepatitis c is solved; and the potential risk caused by human serum is avoided.

Description

Technical field [0001] The invention relates to an enzyme-linked immunoassay kit, in particular, to a harmless positive control for hepatitis C enzyme-linked immunoassay diagnosis, and a preparation method and application thereof. Background technique [0002] Hepatitis C (hepatitis C) is a mainly blood-borne disease, caused by hepatitis C virus (HCV) infection, and it has a global epidemic with an infection rate of about 3%. The infection rate among the general population in my country is 3.2%, 3.6% north of the Yangtze River, and as high as 3.8% and 4.6% in the Central South and Northeast regions respectively. [0003] The harm of hepatitis C is that there are very few cases of spontaneous recovery after HCV infection, and the chronicity rate can be as high as 60%-85%. The consequence is chronic inflammatory necrosis and fibrosis of the liver, which can easily transform into end-stage liver diseases such as cirrhosis and hepatocellular carcinoma (HCC), with a poor prognosis. Ac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/577
CPCG01N33/56983G01N33/5767G01N2333/186
Inventor 李银生李勇莉杨杰周薇张东芳胡亚男刘辉
Owner XINXIANG MEDICAL UNIV
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