Research On Rapid Test Reagent For Hepatitis C Antibody

Hepatitis C virus,referred to as hepatitis C,is a disease caused by hepatitis C virus(HCV)infection,mainly transmitted by blood/body fluids.According to estimates by the World Health Organization,about 180 million people worldwide are infected with hepatitis C,and the global HCV infection rate is about 3%.The anti-HCV positive rate in healthy people in China is 0.7%~3.1%,about 38 million people.Due to the biological characteristics of the virus,the host immune function and other multiple factors,the body immunity is usual difficult to effectively eliminate the virus,resulting in about 50% to 80% of HCV-infected patients develop into chronic hepatitis,of which 20% to 30% will develop into cirrhosis,and 1% to 4% cirrhosis patients deteriorate into hepatocellular cancer each year,causing great harm.Since there are no special effective prevention and treatment methods,and there is no vaccine available to prevent further spread,accurate early diagnosis and cutting off the source of infection are effective means to prevent HCV transmission.In this paper,the detection of hepatitis C virus(HCV)antibody was studied.The rapid detection method of hepatitis C virus antibody was studied by immunochromatography and labeled immunoassay and it was successful.In this paper,we firstly compared the effects of colloidal gold and latex microspheres on hepatitis C recombinant antigen and finally selected the method of labeling colloidal gold.At the same time,we optimized the method of colloidal gold labeling,determined the labeling ratio and optimal PH and then carried out the research of prototype product development.Then through the research of reaction system,materials and dosage,we gradually developed a stable and reliable product prototype,focused on the method and dosage of marking and coating and the effect of drying time on the product,and screened the sample pad formula to make the product prototype is more completed.Finally,further testing of the prototype product showed that the minimum detection limit of the product was 0.5NCU/ml,and the specificity and hook effect were also in line with expectations.The accuracy was high and there was no intra-batch or batch-to-batch difference.The stability verification also shows that the products produced by this system have good stability,and the stability period is up to 2 years and can withstand the high temperature and high humidity transportation environment,the relative sensitivity is 100% and the relative specificity is 98.1%.This product has a good market prospect and can be used for primary screening of hepatitis C patients.After further optimization in the future,the quantitative analysis will be carried out in conjunction with the instrument will be promising.