Saldan Alda, Forner Gabriella, Mengoli Carlo, Tinto Daniel, Fallico Loredana, Peracchi Marta, Gussetti Nadia, Palù Giorgio, Abate Davide
Department of Molecular Medicine, University of Padua, Padua, Italy.
Padua Reference Center for Infections in Pregnancy, Padua General Hospital, Padua, Italy.
J Clin Microbiol. 2016 May;54(5):1352-6. doi: 10.1128/JCM.03128-15. Epub 2016 Mar 9.
Human cytomegalovirus (CMV) infection is a major cause of congenital infection leading to birth defects and sensorineural anomalies, including deafness. Recently, cell-mediated immunity (CMI) in pregnant women has been shown to correlate with congenital CMV transmission. In this study, two interferon gamma release assays (IGRA), the CMV enzyme-linked immunosorbent spot (ELISPOT) and CMV QuantiFERON assays, detecting CMV-specific CMI were compared. These assays were performed for 80 CMV-infected (57 primarily and 23 nonprimarily) pregnant women and 115 controls, including 89 healthy CMV-seropositive pregnant women without active CMV infection, 15 CMV-seronegative pregnant women, and 11 seropositive or seronegative nonpregnant women. Statistical tests, including frequency distribution analysis, nonparametric Kruskal-Wallis equality-of-populations rank test, Wilcoxon rank sum test for equality on unmatched data, and lowess smoothing local regression, were employed to determine statistical differences between groups and correlation between the assays. The CMV ELISPOT and CMV QuantiFERON assay data were not normally distributed and did not display equal variance. The CMV ELISPOT but not CMV QuantiFERON assay displayed significant higher values for primarily CMV-infected women than for the healthy seropositive pregnant and nonpregnant groups (P = 0.0057 and 0.0379, respectively) and those with nonprimary infections (P = 0.0104). The lowess local regression model comparing the assays on an individual basis showed a value bandwidth of 0.8. Both assays were highly accurate in discriminating CMV-seronegative pregnant women. The CMV ELISPOT assay was more effective than CMV-QuantiFERON in differentiating primary from the nonprimary infections. A substantial degree of variability exists between CMV ELISPOT and CMV QuantiFERON assay results for CMV-seropositive pregnant women.
人巨细胞病毒（CMV）感染是导致出生缺陷和包括耳聋在内的感觉神经异常的先天性感染的主要原因。最近，已证明孕妇的细胞介导免疫（CMI）与先天性CMV传播相关。在本研究中，比较了两种检测CMV特异性CMI的干扰素γ释放试验（IGRA），即CMV酶联免疫斑点试验（ELISPOT）和CMV全血γ干扰素检测法。对80名CMV感染孕妇（57名初次感染和23名非初次感染）和115名对照进行了这些检测，对照包括89名无活动性CMV感染的健康CMV血清学阳性孕妇、15名CMV血清学阴性孕妇以及11名血清学阳性或阴性的非孕妇。采用包括频率分布分析、非参数Kruskal-Wallis总体秩和检验、未配对数据的Wilcoxon秩和检验以及局部加权散点平滑估计（lowess）局部回归在内的统计检验来确定组间的统计学差异以及检测方法之间的相关性。CMV ELISPOT试验和CMV全血γ干扰素检测法的数据均不呈正态分布且方差不齐。CMV ELISPOT试验而非CMV全血γ干扰素检测法显示，初次CMV感染的女性的值显著高于健康血清学阳性孕妇和非孕妇组（分别为P = 0.0057和0.0379）以及非初次感染的女性（P = 0.0104）。基于个体比较检测方法的局部加权散点平滑估计（lowess）局部回归模型显示值带宽为0.8。两种检测方法在鉴别CMV血清学阴性孕妇方面都具有高度准确性。CMV ELISPOT试验在区分初次感染和非初次感染方面比CMV全血γ干扰素检测法更有效。对于CMV血清学阳性孕妇，CMV ELISPOT试验和CMV全血γ干扰素检测法的结果之间存在很大程度的变异性。
