Chiereghin Angela, Pavia Claudia, Turello Gabriele, Borgatti Eva Caterina, Baiesi Pillastrini Federico, Gabrielli Liliana, Gibertoni Dino, Marsico Concetta, De Paschale Massimo, Manco Maria Teresa, Ruscitto Antonia, Pogliani Laura, Bellini Marta, Porta Alessandro, Parola Luciana, Scarasciulli Maria Luisa, Calvario Agata, Capozza Manuela, Capretti Maria Grazia, Laforgia Nicola, Clerici Pierangelo, Lazzarotto Tiziana
Microbiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Microbiology Unit, ASST Ovest Milanese, Hospital of Legnano, Milan, Italy.
Front Pediatr. 2022 Jul 6;10:909646. doi: 10.3389/fped.2022.909646. eCollection 2022.
Most infants at risk for cytomegalovirus (CMV)-associated sensorineural hearing loss (SNHL) are unrecognized because of the absence of a universal neonatal CMV screening. The search of CMV-DNA by molecular methods in salivary swabs was demonstrated to be a reliable approach. This study describes the results obtained by carrying out a universal screening for congenital CMV (cCMV) infection including all live-born newborns in three Italian sites, as well as the therapeutic interventions and clinical outcome of the CMV-infected neonates. Moreover, CMV maternal infection's characteristics were evaluated.
To confirm or exclude cCMV infection, a CMV-DNA-positive result on a first salivary swab was followed by repeated saliva and urine samples collected within 21 days of age. Breast milk samples were also collected. The search of CMV-DNA was performed with a single automated quantitative commercial real-time PCR assay, regardless of the type of samples used.
A total of 3,151 newborns were enrolled; 21 (0.66%) of them were congenitally infected (median saliva viral load at screening, 6.65 [range, 5.03-7.17] log IU/ml). Very low/low viral load in screening saliva samples (median value, 1.87 [range, 1.14-2.59] log IU/ml) was associated with false-positive results ( = 54; 1.7%). CMV-DNA was detected in almost half of the breast milk samples of mother-infant pairs with a false-positive result, suggesting that contamination from breast milk may not be the only explanation in the study population. cCMV infection confirmation with the search of CMV-DNA in a urine sample proved to be the gold standard strategy, since false-positive results were observed in 4/54 (7.5%) of the repeated saliva samples. Symptomatic cCMV infection was observed in 3/21 (14.3%) infants; notably, one (4.7%) developed moderate unilateral SNHL at 5 months after birth. Finally, two symptomatic cCMV infections were associated with primary maternal infection acquired in the first trimester of gestation; one newborn with severe cCMV symptoms was born to a mother with no CMV checkups in pregnancy.
Without universal neonatal CMV screening, some infected infants who develop late neurological sequelae may not be recognized and, consequently, they are not able to benefit early from instrumental and therapeutic interventions to limit and/or treat CMV disease.
由于缺乏普遍的新生儿巨细胞病毒（CMV）筛查，大多数有患CMV相关感音神经性听力损失（SNHL）风险的婴儿未被识别。通过分子方法在唾液拭子中检测CMV-DNA被证明是一种可靠的方法。本研究描述了在意大利三个地点对所有活产新生儿进行先天性CMV（cCMV）感染普遍筛查所获得的结果，以及CMV感染新生儿的治疗干预措施和临床结局。此外，还评估了CMV母亲感染的特征。
为确认或排除cCMV感染，首次唾液拭子CMV-DNA检测呈阳性结果后，在出生后21天内收集重复的唾液和尿液样本。还收集了母乳样本。无论使用何种类型的样本，均采用单一的自动化定量商业实时PCR检测法进行CMV-DNA检测。
共纳入3151名新生儿；其中21名（0.66%）先天性感染（筛查时唾液病毒载量中位数为6.65[范围为5.03 - 7.17]log IU/ml）。筛查唾液样本中病毒载量非常低/低（中位数为1.87[范围为1.14 - 2.59]log IU/ml）与假阳性结果相关（n = 54；1.7%）。在假阳性结果的母婴对中，几乎一半的母乳样本检测到CMV-DNA，这表明母乳污染可能不是研究人群中假阳性结果的唯一原因。在尿液样本中检测CMV-DNA以确认cCMV感染被证明是金标准策略，因为在4/54（7.5%）的重复唾液样本中观察到假阳性结果。3/21（14.3%）的婴儿出现有症状的cCMV感染；值得注意的是，其中一名（4.7%）在出生后5个月出现中度单侧SNHL。最后，两例有症状的cCMV感染与妊娠早期获得的原发性母亲感染有关；一名患有严重cCMV症状的新生儿的母亲在孕期未进行CMV检查。
如果没有普遍的新生儿CMV筛查，一些出现晚期神经后遗症的感染婴儿可能未被识别，因此，他们无法早期从限制和/或治疗CMV疾病的仪器和治疗干预中获益。
