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Qualitative detection kit for antibody to hepatitis C (anti-HCV) and preparing method and application thereof

A hepatitis C, qualitative detection technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high cost, low sensitivity of hepatitis C antibody, specificity price difference, etc., and achieve a long stable period of the platform and reliable test results , the effect of small variation

Inactive Publication Date: 2016-04-13
TAIZHOU ZECEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to overcome the defects of low sensitivity, price difference in specificity and high cost of existing hepatitis C antibody detection, and provide a direct-labeled double-antigen hepatitis C antibody with high sensitivity, strong specificity and low cost Antibody (anti-HCV) detection method

Method used

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  • Qualitative detection kit for antibody to hepatitis C (anti-HCV) and preparing method and application thereof
  • Qualitative detection kit for antibody to hepatitis C (anti-HCV) and preparing method and application thereof
  • Qualitative detection kit for antibody to hepatitis C (anti-HCV) and preparing method and application thereof

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Experimental program
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Embodiment

[0049] In addition to the specific binding of the coated antigen and the labeled antibody to the human hepatitis C antibody (HCV), the dual antigen pairing can form a "sandwich" structure with the hepatitis C antibody. The hepatitis C antibody used in this example is an antibody purified from human serum. The hepatitis C antibody coating antigen and labeled antigen used in this example are prepared by purchasing from the famous foreign university Cambridge University.

[0050] 1. The configuration of various buffers:

[0051] 1. Tris salt pH8.0 buffer

[0052] Tris: 12.12g, sodium chloride 5.82g, Proclin3005mL, add 1L purified water, stir well until completely dissolved, adjust the final pH to 7.5 with hydrochloric acid.

[0053] 2. Preparation of calibration solution buffer

[0054] Add 0.01g of tetracycline, 0.1g of neomycin sulfate, and Proclin3005mL to 1L of newborn calf serum, fully dissolve it, and process it with 0.22μm filter membrane.

[0055] 3. Anti-reagent buffer

[0056] Tri...

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Abstract

The invention discloses a qualitative detection kit for antibody to hepatitis C (anti-HCV), which comprises calibration liquid, a negative control product, a positive control product, an anti reagent, a magnetic particle reagent and a luminescent substrate. An alkaline phosphatase is taken as a marker enzyme, and directly marks an anti recombinant antigen by chemical reaction; fluorescein is taken as a marker bridge and directly marks the anti recombinant antigen by chemical reaction; immune magnetic particles are taken as a solid phase, goat-anti fluorescein isothiocyanate antibody is coupling magnetic microspheres are taken as a universal separating reagent; a novel chemiluminescent substrate ALPS is taken as a substrate; the kit is reliable in performance, high in sensitivity and good in specificity and can be used in match with semiautomatic and full automatic instruments. A coincidence rate of positivity and negativity of a national reference product is 100 percent by determining, a clinical coincidence rate is up to 99.7 percent and the kit is suitable for anti-HCV detection and screening.

Description

Technical field [0001] The present invention relates to the detection field of hepatitis C antibodies, in particular to a kit for qualitatively detecting hepatitis C antibodies and a preparation method and application thereof, in particular to a qualitative detection of human hepatitis C antibodies based on magnetic particle separation chemiluminescence ( anti-HCV) kit and its preparation method and application. Background technique [0002] Hepatitis C virus (HCV) is the chief culprit in inducing hepatitis C, which is spread through blood. HCV infection often leads to chronic hepatitis and cirrhosis, and may progress to hepatocellular carcinoma. Clinical symptoms are often accompanied by cryoglobulinemia and various rheumatic diseases. [0003] Hepatitis C virus (HCV) is a single-stranded ortho-strand RNA virus of the Flaviviridae family, which has a capsid. The viral genome is about 9.5 kb in length and encodes a 3000 amino acid polypeptide including structural and non-structu...

Claims

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Application Information

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IPC IPC(8): G01N33/543
CPCG01N33/54326
Inventor 陈海生陈峰孙宏伟邵飞飞刘振国
Owner TAIZHOU ZECEN BIOTECH CO LTD
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