Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, United States.
J Virol Methods. 2009 May;157(2):223-6. doi: 10.1016/j.jviromet.2008.12.011. Epub 2009 Jan 10.
This study evaluated the performance of a new Food and Drug Administration-approved lateral-flow diagnostic screening test for qualitative detection of West Nile Virus (WNV) immunoglobulin M (IgM) in serum or plasma. Five public health laboratories across the United States performed retrospective testing on blinded serum samples from patients with physician reported diagnoses of WNV infection. The results of the RapidWN WNV IgM assay were compared with two commercially available WNV IgM enzyme-linked immunosorbent assays (EIA) and two public health-developed WNV-IgM tests. After discrepancies were resolved, the RapidWN WNV IgM EIA demonstrated a 98.8% sensitivity (range: 96.0-100%), a 95.3% specificity (range: 90.9-100%), a positive predictive value of 96.3% (range: 94.7-100%), and a negative predictive value of 98.4% (range: 95.5-100%), as compared to the predicate assays. The study results suggest that the RapidWN WNV IgM EIA is an effective, qualitative screening test that produces results comparable to that of predicate assays and can be employed rapidly to detect WNV IgM in patients suspected of having WNV infection.
本研究评估了一种新的获得美国食品药品监督管理局批准的侧向流动诊断筛选试验，用于定性检测血清或血浆中的西尼罗河病毒（WNV）免疫球蛋白 M（IgM）。美国五个公共卫生实验室对来自有医生报告的 WNV 感染诊断的患者的盲血清样本进行了回顾性检测。RapidWN WNV IgM 检测的结果与两种市售的 WNV IgM 酶联免疫吸附测定（EIA）和两种公共卫生开发的 WNV-IgM 检测进行了比较。解决差异后，RapidWN WNV IgM EIA 显示出 98.8%的灵敏度（范围：96.0-100%）、95.3%的特异性（范围：90.9-100%）、96.3%的阳性预测值（范围：94.7-100%）和 98.4%的阴性预测值（范围：95.5-100%），与预测性检测相比。研究结果表明，RapidWN WNV IgM EIA 是一种有效的定性筛选检测方法，其结果与预测性检测相当，可快速用于检测疑似感染 WNV 的患者中的 WNV IgM。
