Departments of Pathology, University of Texas Medical Branch, Galveston, TX 77555-0743, USA.
Am J Clin Pathol. 2010 Feb;133(2):242-50. doi: 10.1309/AJCP63VDFCKCRUUL.
BK virus (BKV) is a nonenveloped, double-stranded DNA virus of the polyomavirus family that primarily affects immunocompromised people. BKV may cause nephropathy in renal transplant recipients receiving immunosuppressive therapy, resulting in renal dysfunction and, possibly, graft loss. Monitoring of BK viral load in urine and blood has been used as a surrogate marker of BKV nephropathy (BKVN). Although real-time polymerase chain reaction (PCR) is the method of choice, currently there is no US Food and Drug Administration-approved or standardized BK viral load assay. Different PCR assays vary significantly in sample types, DNA extraction method, PCR primers and probes, and reference materials used to generate a standard curve. These differences can affect the accuracy, specificity, and dynamic ranges of various real-time PCR assays. These analytic differences cause difficulty in comparing test results, making it impossible to establish universal standardized cutoff values that correlate with clinical manifestations of BKVN. In this review, we summarize real-time PCR assays used for managing BKVN.
BK 病毒（BKV）是一种无包膜的、双链 DNA 病毒，属于多瘤病毒科，主要影响免疫功能低下的人群。BKV 可能导致接受免疫抑制治疗的肾移植受者发生肾病，导致肾功能障碍，并且可能导致移植物丢失。监测尿液和血液中的 BK 病毒载量已被用作 BKV 肾病（BKVN）的替代标志物。尽管实时聚合酶链反应（PCR）是首选方法，但目前美国食品和药物管理局（FDA）尚未批准或标准化 BK 病毒载量检测方法。不同的 PCR 检测方法在样本类型、DNA 提取方法、PCR 引物和探针以及用于生成标准曲线的参考材料方面存在显著差异。这些差异会影响各种实时 PCR 检测方法的准确性、特异性和动态范围。这些分析差异导致难以比较检测结果，无法建立与 BKVN 临床表现相关的通用标准化截断值。在这篇综述中，我们总结了用于管理 BKVN 的实时 PCR 检测方法。
