Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
N Engl J Med. 2011 Jun 2;364(22):2111-8. doi: 10.1056/NEJMoa1006561.
Congenital cytomegalovirus (CMV) infection is an important cause of hearing loss, and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The standard assay for newborn CMV screening is rapid culture performed on saliva specimens obtained at birth, but this assay cannot be automated. Two alternatives--real-time polymerase-chain-reaction (PCR)-based testing of a liquid-saliva or dried-saliva specimen obtained at birth--have been developed.
In our prospective, multicenter screening study of newborns, we compared real-time PCR assays of liquid-saliva and dried-saliva specimens with rapid culture of saliva specimens obtained at birth.
A total of 177 of 34,989 infants (0.5%; 95% confidence interval [CI], 0.4 to 0.6) were positive for CMV, according to at least one of the three methods. Of 17,662 newborns screened with the use of the liquid-saliva PCR assay, 17,569 were negative for CMV, and the remaining 85 infants (0.5%; 95% CI, 0.4 to 0.6) had positive results on both culture and PCR assay. The sensitivity and specificity of the liquid-saliva PCR assay were 100% (95% CI, 95.8 to 100) and 99.9% (95% CI, 99.9 to 100), respectively, and the positive and negative predictive values were 91.4% (95% CI, 83.8 to 96.2) and 100% (95% CI, 99.9 to 100), respectively. Of 17,327 newborns screened by means of the dried-saliva PCR assay, 74 were positive for CMV, whereas 76 (0.4%; 95% CI, 0.3 to 0.5) were found to be CMV-positive on rapid culture. Sensitivity and specificity of the dried-saliva PCR assay were 97.4% (95% CI, 90.8 to 99.7) and 99.9% (95% CI, 99.9 to 100), respectively. The positive and negative predictive values were 90.2% (95% CI, 81.7 to 95.7) and 99.9% (95% CI, 99.9 to 100), respectively.
Real-time PCR assays of both liquid- and dried-saliva specimens showed high sensitivity and specificity for detecting CMV infection and should be considered potential screening tools for CMV in newborns. (Funded by the National Institute on Deafness and Other Communication Disorders.).
先天性巨细胞病毒（CMV）感染是导致听力损失的一个重要原因，由于未能对感染进行检测，大多数有 CMV 相关听力损失风险的婴儿未能在生命早期被发现。用于新生儿 CMV 筛查的标准检测方法是在出生时采集唾液标本进行快速培养，但该检测方法无法实现自动化。已经开发出两种替代方法：在出生时采集的液体唾液或干燥唾液标本上进行基于实时聚合酶链反应（PCR）的检测。
在我们对新生儿进行的前瞻性、多中心筛查研究中，我们比较了液体唾液和干燥唾液标本的实时 PCR 检测与出生时采集的唾液标本的快速培养。
根据至少一种方法，共有 34989 名婴儿中的 177 名（0.5%；95%置信区间 [CI]，0.4 至 0.6）为 CMV 阳性。在使用液体唾液 PCR 检测方法筛查的 17662 名新生儿中，17569 名新生儿 CMV 检测为阴性，其余 85 名婴儿（0.5%；95%CI，0.4 至 0.6）的培养和 PCR 检测结果均为阳性。液体唾液 PCR 检测的灵敏度和特异性分别为 100%（95%CI，95.8 至 100）和 99.9%（95%CI，99.9 至 100），阳性和阴性预测值分别为 91.4%（95%CI，83.8 至 96.2）和 100%（95%CI，99.9 至 100）。在通过干燥唾液 PCR 检测方法筛查的 17327 名新生儿中，有 74 名 CMV 阳性，而有 76 名（0.4%；95%CI，0.3 至 0.5）通过快速培养发现 CMV 阳性。干燥唾液 PCR 检测的灵敏度和特异性分别为 97.4%（95%CI，90.8 至 99.7）和 99.9%（95%CI，99.9 至 100）。阳性和阴性预测值分别为 90.2%（95%CI，81.7 至 95.7）和 99.9%（95%CI，99.9 至 100）。
液体和干燥唾液标本的实时 PCR 检测均显示出对 CMV 感染的高灵敏度和特异性，应被视为新生儿 CMV 的潜在筛查工具。（由美国国立耳聋与其他沟通障碍研究所资助）。
