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首页> 外文期刊>Journal of Medical Virology >European collaborative evaluation of the Enzygnost HBsAg 6.0 assay: performance on hepatitis B virus surface antigen variants.
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European collaborative evaluation of the Enzygnost HBsAg 6.0 assay: performance on hepatitis B virus surface antigen variants.

机译:欧洲对Enzygnost HBsAg 6.0分析的协作评估:乙型肝炎病毒表面抗原变异体的性能。

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Amino acid changes within the major antigenic determinant of the hepatitis B virus (HBV) surface antigen (HBsAg) may modify eventually the antigenic properties of the protein and may have impact on the sensitivity of diagnostic assays. Modifications in the design of an assay can, however, improve significantly its ability to detect HBV mutants. One hundred forty-seven clinical samples containing HBsAg variants, and 54 supernatants of cells expressing recombinant HBsAg mutants were tested by two generations of a commercial HBsAg test (Enzygnost(R) HBsAg 5.0 and 6.0, Siemens Healthcare Diagnostics Products, Marburg, Germany), and the results were compared. A significant improvement was demonstrated for the second test by comparing the mean and individual sample/cut-off values, as well as by the detection of several samples displaying amino acid changes in residues 120 and 145 of the HBsAg which were recorded as negative by the former test. The results showed that modifications in design of the assay improved considerably the ability of the test to detect HBsAg mutants, and that difficulties in detecting such HBV variants should not be expected with the routine use of the test in diagnostic laboratories and in blood transfusion centers.
机译:乙型肝炎病毒(HBV)表面抗原(HBsAg)的主要抗原决定簇中的氨基酸变化最终可能会改变蛋白质的抗原特性,并可能影响诊断分析的敏感性。但是,分析设计的修改可以显着提高其检测HBV突变体的能力。通过两代商业HBsAg测试(Enzygnost®HBsAg 5.0和6.0,Siemens Healthcare Diagnostics Products,Marburg,德国)对包含HBsAg变异体的47个临床样品和表达重组HBsAg突变体的细胞的54上清液进行了测试,并比较结果。通过比较平均值和单个样品/截留值,以及检测到几个显示HBsAg残基120和145中氨基酸变化的样品,证明第二次测试有显着改善,这些样品被HBsAg记录为阴性。前测试。结果表明,对试验设计的修改大大提高了该试验检测HBsAg突变体的能力,并且在诊断实验室和输血中心常规使用该试验不应期望在检测此类HBV变异体方面遇到困难。

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