一项关于 VERIS HBV 检测方法分析性能的欧洲多中心研究。
A European multicenter study on the analytical performance of the VERIS HBV assay.
机构信息
Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany.
Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i + 12), Madrid, Spain.
出版信息
J Clin Virol. 2018 Feb-Mar;99-100:50-56. doi: 10.1016/j.jcv.2017.12.009. Epub 2017 Dec 19.
BACKGROUND
Hepatitis B viral load monitoring is an essential part of managing patients with chronic Hepatits B infection. Beckman Coulter has developed the VERIS HBV Assay for use on the fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System. OBJECTIVES: To evaluate the analytical performance of the VERIS HBV Assay at multiple European virology laboratories.
STUDY DESIGN
Precision, analytical sensitivity, negative sample performance, linearity and performance with major HBV genotypes/subtypes for the VERIS HBV Assay was evaluated.
RESULTS
Precision showed an SD of 0.15 log IU/mL or less for each level tested. Analytical sensitivity determined by probit analysis was between 6.8-8.0 IU/mL. Clinical specificity on 90 unique patient samples was 100.0%. Performance with 754 negative samples demonstrated 100.0% not detected results, and a carryover study showed no cross contamination. Linearity using clinical samples was shown from 1.23-8.23 log IU/mL and the assay detected and showed linearity with major HBV genotypes/subtypes.
CONCLUSIONS
The VERIS HBV Assay demonstrated comparable analytical performance to other currently marketed assays for HBV DNA monitoring.
背景
乙型肝炎病毒载量监测是慢性乙型肝炎感染患者管理的重要组成部分。贝克曼库尔特公司开发了 VERIS HBV 检测试剂盒，用于全自动贝克曼库尔特 DxN VERIS 分子诊断系统。目的：在多个欧洲病毒学实验室评估 VERIS HBV 检测试剂盒的分析性能。
研究设计
评估 VERIS HBV 检测试剂盒的精密度、分析灵敏度、阴性样本性能、线性和主要乙型肝炎病毒基因型/亚型的性能。
结果
精密度显示每个测试水平的 SD 小于或等于 0.15 log IU/mL。通过概率分析确定的分析灵敏度在 6.8-8.0 IU/mL 之间。90 个独特患者样本的临床特异性为 100.0%。754 个阴性样本的性能显示 100.0%未检出结果，且携带污染研究显示无交叉污染。使用临床样本显示线性范围为 1.23-8.23 log IU/mL，该检测试剂盒可检测并显示主要乙型肝炎病毒基因型/亚型的线性。
结论
VERIS HBV 检测试剂盒的分析性能与其他目前市场上用于乙型肝炎病毒 DNA 监测的检测试剂盒相当。
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