Faculty of Medicine, Universidad de Chile, Department of Pediatrics, Santiago, Chile.
Hospital Barros Luco Trudeau, Neonatal Intensive Care Unit, Santiago, Chile.
Eur J Pediatr. 2023 Nov;182(11):5131-5136. doi: 10.1007/s00431-023-05183-x. Epub 2023 Sep 9.
Universal congenital cytomegalovirus (cCMV) screening in saliva is increasingly recommended. The aim of our study was to correlate the performance of a point-of-care rapid molecular test with CMV real time PCR (CMV RT-PCR) detection, using saliva pool-testing in newborns under a universal screening strategy. Saliva swabs were prospectively collected from newborns < 21 days old and tested by Alethia-LAMP-CMV assay in pools of 5 samples. In positive pools, subjects were tested individually and by saliva and urine CMV RT-PCR. A subset of negative pools were studied with both techniques and viral loads in whole blood were determined in positive patients. From 1,642 newborns included in 328 pools, 8 were confirmed by urine CMV RT-PCR, (cCMV prevalence 0,49%). The PPA and NNA of the pooled saliva Alethia-LAMP-CMV testing were 87,5% and 99,8% with a negative and positive predictive value of 99,9% and 77,7%, respectively. Two false positives were detected (0,12%). A subset of 17 negative pools (85 samples), studied by saliva CMV RT-PCR, showed 100% concordance. Conclusion: CMV pool-testing using a rapid molecular test in saliva proved feasible when compared to PCR gold standards. This strategy could improve cost-effectiveness for cCMV universal neonatal screening, based on the low prevalence of the infection and could be a more affordable approach in less developed regions with reduced detection capacity. What is Known: • cCMV is the most frequent congenital infection and a leading nongenetic cause of sensorineural hearing loss and brain disease. • Universal screening could allow early detection of congenitally infected infants, improving clinical outcome. • Saliva PCR is the preferred and non-invasive test for newborn cCMV screening. What is New: • The feasibility of a universal cCMV screening by pool-testing in saliva using a rapid test in pools of 5 samples. • PPA and NPA were 87,5 and 99,8% compared to CMV PCR in urine. • This strategy could be relevant specially in LMIC where detection capacity is reduced and could improve cost-effectiveness. • cCMV prevalence in our center was 0,49%.
普遍的先天性巨细胞病毒（cCMV）唾液筛查越来越受到推荐。本研究的目的是通过在普遍筛查策略下对新生儿进行唾液池检测，比较即时聚合酶链反应（CMV RT-PCR）检测与床边快速分子检测的性能。前瞻性收集了 <21 天的新生儿的唾液拭子，并使用 Alethia-LAMP-CMV 检测试剂盒对 5 个样本的唾液池进行检测。在阳性池中，对受试者进行单独检测，并使用唾液和尿液 CMV RT-PCR 进行检测。用两种技术对部分阴性池进行研究，并在阳性患者中检测全血中的病毒载量。从 328 个池中的 1642 名新生儿中，8 名通过尿液 CMV RT-PCR 确诊，（cCMV 患病率 0.49%）。经尿液 CMV RT-PCR 检测，Alethia-LAMP-CMV 唾液池检测的阳性预测值和阴性预测值分别为 87.5%和 99.8%，阳性和阴性的准确度分别为 99.9%和 77.7%。检测到 2 例假阳性（0.12%）。用唾液 CMV RT-PCR 对 17 个阴性池（85 个样本）的子集进行研究，结果显示完全一致。结论：与聚合酶链反应金标准相比，使用快速分子检测对唾液进行 CMV 池检测是可行的。基于感染的低流行率和检测能力降低的欠发达国家更能负担得起，这种策略可以提高 cCMV 新生儿普遍筛查的成本效益。已知：•cCMV 是最常见的先天性感染，也是感音神经性听力损失和脑疾病的主要非遗传原因。•普遍筛查可早期发现先天性感染的婴儿，改善临床结局。•唾液 PCR 是新生儿 cCMV 筛查的首选和非侵入性检测。新内容：•使用快速检测试剂盒对 5 个样本的唾液进行普遍的 cCMV 筛查，并通过快速检测对其进行池检测的可行性。•与尿液中的 CMV PCR 相比，阳性预测值和阴性预测值分别为 87.5%和 99.8%。•在检测能力降低的中低收入国家，这种策略可能特别重要，因为它可以提高成本效益。•本中心的 cCMV 患病率为 0.49%。
