Hübner Margit, Bozic Michael, Konrad Petra M, Grohs Katharina, Santner Brigitte I, Kessler Harald H
Research Unit Molecular Diagnostics and Molecular Diagnostics Laboratory, IHMEM, Medical University of Graz, Graz, Austria.
Institute for Laboratory Medicine, Kaiser Franz Josef Hospital, Vienna, Austria.
J Virol Methods. 2015 Feb;212:39-43. doi: 10.1016/j.jviromet.2014.11.002. Epub 2014 Nov 13.
Quantitation of EBV DNA has been shown to be a useful tool to identify and monitor patients with immunosuppression and high risk for EBV-associated disease. In this study, the analytical and clinical performance of the new Realquality RS-EBV Kit (AB Analitica, Padova, Italy) was investigated. The clinical performance was compared to that of the EBV R-gene (bioMerieux, Varilhes, France) assay. When the accuracy of the new assay was tested, all results except of one were found to be within ±0.5log10 unit of the expected panel results. Determination of linearity showed a quasilinear curve, the between day imprecision ranged from 18% to 88% and the within run imprecision from 16% to 53%. When 96 clinical EDTA whole blood samples were tested, 77 concordant and 19 discordant results were obtained. When the results for the 69 samples quantifiable with both assays were compared, the new assay revealed a mean 0.31log10 unit higher measurement. The new assay proved to be suitable for the detection and quantitation of EBV DNA in EDTA whole blood in the routine diagnostic laboratory. The variation between quantitative results obtained by the assays used in this study reinforces the use of calibrators traceable to the existing international WHO standard making different assays better comparable.
EBV DNA定量已被证明是识别和监测免疫抑制及EBV相关疾病高风险患者的有用工具。在本研究中，对新型Realquality RS-EBV试剂盒（AB Analitica，意大利帕多瓦）的分析性能和临床性能进行了研究。将其临床性能与EBV R基因检测法（bioMerieux，法国瓦里勒）进行了比较。在测试新检测法的准确性时，发现除一个结果外，所有结果均在预期检测组结果的±0.5log10单位范围内。线性测定显示为拟线性曲线，日间不精密度范围为18%至88%，批内不精密度范围为16%至53%。对96份临床EDTA全血样本进行检测时，获得了77份一致结果和19份不一致结果。当比较两种检测法均可定量的69份样本的结果时，新检测法显示测量值平均高0.31log10单位。新检测法被证明适用于常规诊断实验室中EDTA全血中EBV DNA的检测和定量。本研究中使用的检测法所获得的定量结果之间的差异，强化了使用可溯源至现有WHO国际标准的校准品，以使不同检测法具有更好的可比性。
