University of Graz, Institute for Hygiene, Universitätsplatz 4, Graz 8010, Austria.
BMC Infect Dis. 2013 Jun 3;13:260. doi: 10.1186/1471-2334-13-260.
Diagnosis of Epstein-Barr virus (EBV) infection is routinely conducted by clinical laboratories, especially to diagnose infectious mononucleosis. At an estimated general population incidence of 1:200, this represents a potentially significant testing burden. We evaluated the reliability of the Siemens Novagnost® and Enzygnost® EBV microtiter assays measuring VCA IgM and IgG, and EBNA-1 IgG for clinical diagnosis of EBV-related infectious mononucleosis.
Remnant sera from 537 patients tested for EBV infection were used to compare the Siemens assays to each other and to the Merifluor assay. The Siemens assays are qualitative/semiquantitative, automatable enzyme immunoassays. The Merifluor assays are manual, qualitative indirect immunofluorescent assays. Testing was conducted on the Siemens and Merifluor assays in parallel. All assays were conducted and interpreted according to each manufacturer's specifications. Agreement of serostatus between each of the three assays was assessed. Discrepant results were resolved using a third method (Mikrogen recomLine).
Final EBV serostatus indicated 2.9% of the population had an acute infection, 89.6% had a past infection, and 7.5% were EBV naive. All three assays demonstrated 100% agreement with acute infection. Agreement with past-infection serostatus was 99.1% for Enzygnost, between 86% and 98.8% for Novagnost, and 98.1% for Merifluor. Seronegative agreement was 100% for Enzygnost, 89.7% for Novagnost, and 92.3% for Merifluor.
The Siemens Enzygnost and Novagnost EBV microtiter assays are suitable for clinical rule-in of acute EBV infection and for identifying EBV-naive individuals. Both assays also adequately identify remote EBV infections. Because these assays can be automated, they can improve speed and efficiency of EBV testing, especially in high-volume laboratories.
EBV 感染的诊断通常由临床实验室进行，特别是用于诊断传染性单核细胞增多症。在一般人群中，估计发病率为 1:200，这代表了潜在的大量检测负担。我们评估了西门子 Novagnost®和 Enzygnost® EBV 微量滴定法检测 VCA IgM 和 IgG 以及 EBNA-1 IgG 在 EBV 相关传染性单核细胞增多症临床诊断中的可靠性。
使用 537 例检测 EBV 感染的患者的剩余血清，将西门子检测与彼此以及 Merifluor 检测进行比较。西门子检测是定性/半定量、自动化酶免疫分析。Merifluor 检测是手动、定性间接免疫荧光检测。西门子和 Merifluor 检测同时进行平行检测。所有检测均根据制造商的规格进行，并根据制造商的规格进行解释。评估了三种检测之间的血清状态一致性。使用第三种方法（Mikrogen recomLine）解决了不一致的结果。
最终 EBV 血清状态表明，2.9%的人群发生急性感染，89.6%有既往感染，7.5%为 EBV 初筛阴性。所有三种检测方法均显示 100%与急性感染一致。与既往感染的血清状态一致的是 Enzygnost 为 99.1%，Novagnost 为 86%-98.8%，Merifluor 为 98.1%。Enzygnost 的血清学阴性一致率为 100%，Novagnost 为 89.7%，Merifluor 为 92.3%。
西门子 Enzygnost 和 Novagnost EBV 微量滴定法检测适用于 EBV 急性感染的临床规则纳入和 EBV 初筛阴性个体的鉴定。这两种检测方法也能充分识别 EBV 远期感染。由于这些检测可以自动化，因此可以提高 EBV 检测的速度和效率，尤其是在高容量实验室中。
