商业酶联免疫吸附试验在临床环境下用于单纯疱疹病毒-1 和单纯疱疹病毒-2 感染诊断的性能。
Performance of Commercial Enzyme-Linked Immunoassays for Diagnosis of Herpes Simplex Virus-1 and Herpes Simplex Virus-2 Infection in a Clinical Setting.
机构信息
From the *Department of Medicine, †Department of Laboratory Medicine, University of Washington, Seattle, WA; ‡Westover Heights Clinic, Portland, OR; §Department of Biostatistics, University of Washington; ¶Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center; and ∥Department of Epidemiology, University of Washington, Seattle, WA.
出版信息
Sex Transm Dis. 2017 Dec;44(12):763-767. doi: 10.1097/OLQ.0000000000000689.
BACKGROUND
US Food and Drug Administration-approved enzyme-linked immunoassays (EIA) for determining type-specific herpes simplex virus (HSV) serostatus are widely used in clinical practice. We compared the performance of such assays with the University of Washington Western blot (UW WB) in patients who sought confirmation of their HSV serology result.
METHODS
We reviewed charts of all persons evaluated at the Westover Heights Clinic in Portland, Oregon, from July 2010 through September 2015, who had a HSV EIA, followed by UW WB.
RESULTS
Of 864 persons, 47% were women. The median age was 36 years (range, 18-73 years). Using UW WB to define infection status, 286 (33%) persons were HSV-1 seropositive only, 104 (12%) were HSV-2 seropositive only, 134 (16%) were both HSV-1 and HSV-2 seropositive, 235 (27%) were HSV seronegative, and 105 (12%) had indeterminate results. Compared with the UW WB as the criterion standard, EIA was 70.2% sensitive and 91.6% specific for HSV-1, and 91.9% sensitive and 57.4% specific for HSV-2.Among 278 persons who were HSV-1 seropositive by EIA, 255 were confirmed by the UW WB (positive predictive value [PPV], 91.7%). Of the 360 persons that were HSV-1 seronegative by the EIA, 252 were seronegative by UW WB (negative predictive value [NPV], 70.0%). Among 381 persons with HSV-2 EIA seropositivity, 193 tested HSV-2 seropositive by the UW WB (PPV, 50.7%). Of the 270 persons HSV-2 seronegative by EIA, 17 were seropositive with the UW WB (NPV, 93.7%). Among 261 persons with an EIA HSV-2 index value = 1.1-2.9, 39.8% of results were confirmed by UW WB, compared with 78.6% of the 70 persons with an EIA index value of 3 or greater (P < 0.001). The risk of false-positive HSV-2 EIA results was higher in those with HSV-1 antibody (47.1% vs 37.1%, P = 0.036).
CONCLUSIONS
US Food and Drug Administration-approved EIAs have poor PPV for HSV-2 and poor NPV for HSV-1 in clinical practice. More accurate rapid type-specific HSV antibody tests are needed.
背景
美国食品和药物管理局批准的用于确定单纯疱疹病毒（HSV）血清型特异性的酶联免疫吸附测定（EIA）在临床实践中被广泛使用。我们比较了这些检测方法与华盛顿大学 Western blot（UW WB）在寻求确认其 HSV 血清学结果的患者中的表现。
方法
我们回顾了 2010 年 7 月至 2015 年 9 月在俄勒冈州波特兰市 Westover Heights 诊所接受评估的所有患者的图表，这些患者进行了 HSV EIA 检测，随后进行了 UW WB 检测。
结果
864 名患者中，47%为女性。中位年龄为 36 岁（范围，18-73 岁）。使用 UW WB 来定义感染状态，286 名（33%）患者仅为 HSV-1 血清阳性，104 名（12%）患者仅为 HSV-2 血清阳性，134 名（16%）患者同时为 HSV-1 和 HSV-2 血清阳性，235 名（27%）患者为 HSV 血清阴性，105 名（12%）患者结果不确定。与 UW WB 作为标准相比，EIA 对 HSV-1 的敏感性为 70.2%，特异性为 91.6%，对 HSV-2 的敏感性为 91.9%，特异性为 57.4%。在 278 名通过 EIA 检测到 HSV-1 血清阳性的患者中，255 名患者通过 UW WB 得到了确认（阳性预测值[PPV]，91.7%）。在 360 名通过 EIA 检测到 HSV-1 血清阴性的患者中，252 名患者通过 UW WB 检测到血清阴性（阴性预测值[NPV]，70.0%）。在 381 名 HSV-2 EIA 血清阳性的患者中，193 名患者通过 UW WB 检测到 HSV-2 血清阳性（PPV，50.7%）。在 270 名 HSV-2 EIA 血清阴性的患者中，17 名患者通过 UW WB 检测到血清阳性（NPV，93.7%）。在 261 名 HSV-2 EIA 指数值为 1.1-2.9 的患者中，39.8%的结果得到 UW WB 的确认，而在 70 名 EIA 指数值为 3 或更高的患者中，有 78.6%得到确认（P<0.001）。在 HSV-1 抗体阳性的患者中，HSV-2 EIA 假阳性结果的风险更高（47.1% vs 37.1%，P=0.036）。
结论
美国食品和药物管理局批准的 EIA 在临床实践中对 HSV-2 的 PPV 较差，对 HSV-1 的 NPV 较差。需要更准确的快速型特异性 HSV 抗体检测。
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