Research Unit Molecular Diagnostics, Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria.
Clin Chem Lab Med. 2010 Mar;48(3):413-8. doi: 10.1515/CCLM.2010.064.
Detection and quantitation of Epstein-Barr virus (EBV) DNA in EDTA whole blood samples has gained significance in the routine diagnostic laboratory.
In this study, the analytical and clinical performance of the artus EBV RG PCR kit in conjunction with automated sample preparation on the QIAsymphony SP instrument was evaluated.
When the accuracy of the new test system was tested, all results were found to be within +/-0.5 log(10) unit of the expected panel results. Determination of linearity showed a quasilinear curve over 4 log units. The lower limit of detection was determined to be 391 EBV DNA copies/mL in EDTA whole blood. The between day imprecision ranged from 18% to 66%, and the within run imprecision ranged from 11% to 50%. When clinical samples were tested and the results compared with those obtained with the routinely used easyMAG sample preparation and EBV R-gene test system, 60 samples tested positive and 31 samples tested negative by both assays. Nineteen samples were found to be positive using the QIAsymphony sample preparation and artus EBV RG PCR test system only, and no samples tested positive with the routinely used test system only.
The QIAsymphony sample preparation and artus EBV RG PCR test system is suitable for the detection and quantitation of EBV DNA in EDTA whole blood in the routine diagnostic laboratory.
在常规诊断实验室中，检测和定量 EDTA 全血样本中的 Epstein-Barr 病毒 (EBV) DNA 变得越来越重要。
在这项研究中，评估了 artus EBV RG PCR 试剂盒与 QIAsymphony SP 仪器自动样本制备相结合的分析和临床性能。
当测试新测试系统的准确性时，所有结果都发现与预期的面板结果相差 0.5 个对数（10）单位。线性度测定显示在 4 个对数单位以上呈准线性曲线。EDTA 全血中 EBV DNA 的检测下限确定为 391 拷贝/mL。批内不精密度范围为 18%至 66%，批内不精密度范围为 11%至 50%。当测试临床样本并将结果与常规使用的 easyMAG 样本制备和 EBV R 基因测试系统进行比较时，两种检测方法均检测到 60 份样本为阳性，31 份样本为阴性。使用 QIAsymphony 样本制备和 artus EBV RG PCR 测试系统仅发现 19 份样本为阳性，而常规使用的测试系统未检测到阳性样本。
QIAsymphony 样本制备和 artus EBV RG PCR 测试系统适用于常规诊断实验室中 EDTA 全血中 EBV DNA 的检测和定量。
