HCV-DAS酶联免疫法企业参考品的制备

北京理工大学珠海学院2020届本科生毕业论文Preparation of enterprise reference by HCV-DAS enzyme-linkedimmunoassayAbstractFor hepatitis C virus antibody diagnostic reagents enterprise reference,collectingsamples from zhuhai blood station and a number of hospitals,using a variety of reagents totest the 110 blood samples collected,choose 84 samples,with 5 kinds of domestic anti-HCVenzyme-linked immunoassay reagent for testing,then confirmed by HCV BLOT 3.0 reagentform MP.In combination with all the test results,30 positive reference materials,30 negativereference materials,4 limited reference materials and 1 repetitive reference materials wereprepared to establish the HCV-DAS enzyme-linked immunoassay reference materials.Thequalified criteria for establishing HCV-DAS enzyme-linked immunological products are:30negative reference products compliance rate (-/-)s 29/30;30 positive reference productscompliance rate (+/)s 29/30;test limited reference LI to L2 is positive,L3 is positive ornegative,L4 is negative;repeated references are continuously tested for 10 consecutive CV issmaller than 15%.Then three batches of HCV-DAS enzyme-linked immunoassay diagnostic kits from zhuhai livzon diagnostics inc,was used to confirm the established HCV-DAS enzyme-linkedimmunological enterprise reference,and confirmed that the result was:30 negative referenceswith a compliance rate of 30/30,30 The positive reference compliance rate of the positivereference products is 30/30,the test limit reference products LI to L2 are positive,L3 to L4are negative,the repetitive reference products continuous parallel test 10 times CV between2%to 5%,in line with the qualified standards.Keywords:hepatitis c virus;antibody;diagnostic reagent;enterprise referenceⅡ