Ahsanuddin Arshad N, Standish M Craig, Caliendo Angela M, Hill Charles E, Nolte Frederick S
Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Emory University Hospital, Atlanta, GA 30322, USA.
Am J Clin Pathol. 2008 Dec;130(6):865-9. doi: 10.1309/AJCP04IZAMPISEWQ.
We describe the validation of a test for the quantification of Epstein-Barr virus (EBV) DNA (viral load) using the Artus EBV TM PCR analyte-specific reagent (ASR; QIAGEN Hamburg, Hamburg, Germany). A dilution series demonstrated a limit of detection of 2.25 log(10) copies/mL (>95% positivity rate). The limit of quantification was 3.90 log(10) copies/mL based on an SD of less than 0.15. The assay was linear from 2.17 to 6.2 log(10) copies/mL. Low (3.70 log(10) copies/mL) and high (5.40 log(10) copies/mL) patient samples had coefficients of variation (CVs) of 2.0% and 1.4%, respectively. The cycle thresholds of 4 points used to generate the standard curve had CVs ranging from 0.8% to 1.6%. A comparison of 35 matched samples showed a small positive bias (0.35 log(10) copies/mL) for the Artus ASR relative to a laboratory-developed EBV viral load assay targeting the Bam H1-W region of the EBV genome.
我们描述了使用阿图斯爱泼斯坦-巴尔病毒（EBV）TM PCR分析物特异性试剂（ASR；德国汉堡QIAGEN公司）对EBV DNA（病毒载量）进行定量检测的验证情况。稀释系列显示检测限为2.25 log(10)拷贝/毫升（阳性率>95%）。基于标准差小于0.15，定量限为3.90 log(10)拷贝/毫升。该检测在2.17至6.2 log(10)拷贝/毫升范围内呈线性。低病毒载量（3.70 log(10)拷贝/毫升）和高病毒载量（5.40 log(10)拷贝/毫升）的患者样本变异系数（CV）分别为2.0%和1.4%。用于生成标准曲线的4个点的循环阈值CV范围为0.8%至1.6%。对35份匹配样本的比较显示，相对于针对EBV基因组Bam H1-W区域的实验室自行开发的EBV病毒载量检测方法，阿图斯ASR存在较小的正偏差（0.35 log(10)拷贝/毫升）。
