Molecular Diagnostics Laboratory, Universtiy of Maryland Medical Center, Baltimore, Maryland.
Division of Molecular Pathology, Department of Pathololgy, University of Maryland School of Medicine, Baltimore, Maryland.
J Med Virol. 2018 Oct;90(10):1611-1619. doi: 10.1002/jmv.25226. Epub 2018 Jun 12.
Cytomegalovirus (CMV) infection is a leading cause of loss of hearing, vision, and mental retardation in congenitally infected children. It is also associated with complications of organ transplant and opportunistic HIV coinfection. The Roche COBAS AmpliPrep/COBAS TaqMan CMV test is an FDA-approved test that measures CMV DNA viral load in plasma for the diagnosis and management of patients at risk of CMV-associated diseases. Besides plasma, CMV is often found in bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), and urine. Thus, monitoring of CMV for critical care of patients in these nonplasma samples becomes necessary. The objective of this study was to conduct an analytic and clinical feasibility study of the Roche CMV test in BAL, CSF, and urine. The lower limit of detection, analytic measurement range, assay sensitivity, specificity, and precision were determined. Results of this study showed that the lower limit of detections were 50, 100, and 300 IU/mL for BAL, CSF, or urine, respectively. The analytic measurement ranges were from log 2.48 to log 5.48. The assay specificity was 94.4% for BAL and 100% for CSF and urine. The assay precision was all within the acceptable range. The performance of Roche test was further compared with 2 comparators including the RealTime CMV assay (Abbott Molecular) and a CMV Quantitative Polymerase Chain Reaction test (Vela Diagnostics). There was a general positive correlation between the Roche method and the Abbott or the Vela method. Overall, this study suggests that the Roche CMV test is suitable for the quantification of CMV viral load DNA in the described nonplasma samples.
巨细胞病毒（CMV）感染是导致先天性感染儿童失聪、失明和智力迟钝的主要原因。它还与器官移植和机会性 HIV 合并感染的并发症有关。罗氏 COBAS AmpliPrep/COBAS TaqMan CMV 检测是一种获得 FDA 批准的检测方法，用于测量血浆中 CMV DNA 病毒载量，以诊断和管理有 CMV 相关疾病风险的患者。除了血浆，CMV 通常存在于支气管肺泡灌洗液（BAL）、脑脊液（CSF）和尿液中。因此，对这些非血浆样本中的 CMV 进行监测对于患者的重症监护变得非常必要。本研究的目的是对罗氏 CMV 检测在 BAL、CSF 和尿液中的分析和临床可行性进行研究。确定了检测的下限、分析测量范围、检测灵敏度、特异性和精密度。研究结果表明，BAL、CSF 或尿液的检测下限分别为 50、100 和 300IU/ml。分析测量范围从 log2.48 到 log5.48。该检测的特异性为 BAL 94.4%，CSF 和尿液为 100%。检测的精密度均在可接受的范围内。罗氏检测的性能还与包括 RealTime CMV 检测（雅培分子）和 CMV 定量聚合酶链反应检测（Vela 诊断）在内的 2 种对照方法进行了比较。罗氏方法与雅培或 Vela 方法之间存在普遍的正相关。总体而言，本研究表明罗氏 CMV 检测适用于描述的非血浆样本中 CMV 病毒载量 DNA 的定量。
