Texas Children's Hospital, Houston, Texas, USA.
Children's Mercy Hospital, Kansas City, Missouri, USA.
J Clin Microbiol. 2023 Jun 20;61(6):e0028323. doi: 10.1128/jcm.00283-23. Epub 2023 May 15.
Cytomegalovirus (CMV) is the most common virus associated with congenital infection worldwide and is a major cause of sensorineural hearing loss (SNHL) and developmental delay. Up to 90% of infants with congenital CMV (cCMV) infection are asymptomatic at birth, making the diagnosis challenging. Postnatal diagnosis involves testing newborn saliva and/or urine collected before 21 days of life to confirm cCMV infection. This multicenter study evaluated the performance of the Simplexa Congenital CMV Direct real-time PCR assay for the qualitative detection of CMV in newborn saliva ( = 2,023) and urine ( = 1,797) specimens. Compared to two PCR/bidirectional sequencing assays, the Simplexa Congenital CMV Direct assay demonstrated positive percent agreement (PPA) and negative percent agreement (NPA) of 98.6% and 99.9%, respectively, for saliva samples and a PPA of 97.8% and an NPA of 99.9% for urine specimens. Overall concordance was κ = 0.98 or near perfect compared to the composite reference methods with both sample types. By 95% probit analysis, the limit of detection (LoD) using the AD-169 reference strain was 350 ± 12 copies/mL in urine. The LoDs of saliva swabs in either 1 mL or 3 mL of transport medium were 274 ± 12 copies/mL and 300 ± 14 copies/mL, respectively. The Simplexa Congenital CMV Direct assay can be applied to both saliva and urine specimens collected from newborns less than 21 days of age to rapidly and reliably identify CMV infection.
巨细胞病毒（CMV）是全球范围内与先天性感染相关的最常见病毒，也是感音神经性听力损失（SNHL）和发育迟缓的主要原因。多达 90%的先天性 CMV（cCMV）感染婴儿在出生时无症状，这使得诊断具有挑战性。产后诊断包括检测新生儿在 21 天之前采集的唾液和/或尿液，以确认 cCMV 感染。这项多中心研究评估了 Simplexa 先天性 CMV 直接实时 PCR 检测法在定性检测新生儿唾液（ = 2023）和尿液（ = 1797）标本中 CMV 的性能。与两种 PCR/双向测序检测方法相比，Simplexa 先天性 CMV 直接检测法在唾液样本中的阳性百分一致率（PPA）和阴性百分一致率（NPA）分别为 98.6%和 99.9%，尿液样本的 PPA 为 97.8%，NPA 为 99.9%。与两种样本类型的复合参考方法相比，总体一致性为 κ = 0.98 或接近完美。通过 95%概率分析，使用 AD-169 参考株的检测限（LoD）在尿液中为 350 ± 12 拷贝/mL。在 1 mL 或 3 mL 运输介质中采集的唾液拭子的 LoD 分别为 274 ± 12 拷贝/mL 和 300 ± 14 拷贝/mL。Simplexa 先天性 CMV 直接检测法可应用于采集自 21 天以下新生儿的唾液和尿液标本，以快速、可靠地识别 CMV 感染。
