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背景先天性巨细胞病毒(CMV)感染是导致听力受损的重要原因之一,对于存有听力受损风险的大多数婴儿来说,之所以未能在其生命早期加以识别,是由于缺乏CMV感染的检测方法。新生儿CMV标准筛查测定为出生时唾液标本快速培养,已开展了两种选择性检测:出生时液状唾液和干唾液即时聚合酶链反应(PCR)检测法。方法采用前瞻性多元性研究,将新生儿出生时液状唾液及干唾液即时PCR与唾液标本快速培养进行对照。结果 34 989例婴儿至少采用3种方法中的1种,177例(0.5%)[95%CI(0.4,0.6)]呈CMV阳性。采用液状唾液PCR测定法对17 662例新生儿进行筛查,17 569例呈CMV阴性,85例婴儿(0.5%)[95%CI(0.4,0.6)]培养及PCR测定结果均呈阳性。液状唾液PCR测定的敏感性及特异性分别为100.0%[95%CI(95.8,100.0)]和99.9%[95%CI(99.9,100.0)]。阳性及阴性预测值分别为91.4%[95%CI(83.8,96.2)]和100.0%[95%CI(99.9,100.0)]。采用干唾液PCR测定法对17 327例新生儿进行筛查,74例呈CMV阳性,而快速培养76例(0.4%)[95%CI(0.3,0.5)]呈CMV阳性。干唾液PCT测定法的敏感性及特异性分别为97.4%[95%CI(90.8,99.7)]和99.9%[95%CI(99.9,100.0)]。阳性和阴性的预测值分别为90.2%[95%CI(81.7,95.7)]和99.9%[95%CI(99.9,100.0)]。结论出生时液状唾液及干唾液即时PCR测定法筛查CMV感染均具有高敏感和特异性,应考虑作为新生儿CMV的筛查工具。
Background Congenital cytomegalovirus (CMV) infection is one of the major causes of hearing loss and the failure of most infants at risk of hearing impairment to be identified early in their lives is due to a lack of CMV Infection detection method. Neonatal CMV Standard Screening Assay For rapid culture of saliva samples at birth, two selective tests have been performed: liquid saliva at birth and dry saliva real-time polymerase chain reaction (PCR). Methods A prospective and multiplex study was conducted to compare the rapid salivary and salivary PCR and saliva samples of newborns at birth. Results Of 34 989 infants, at least one of three methods was used, and 177 (0.5%) [95% CI (0.4, 0.6)] were CMV positive. A total of 17,662 newborns were screened by liquid saliva PCR assay, 17,569 were negative for CMV, and 85 infants (0.5%) [95% CI (0.4,0.6)] were positive for culture and PCR assay. The sensitivity and specificity for liquid saliva PCR assays were 100.0% [95% CI (95.8,100.0)] and 99.9% [95% CI (99.9,100.0)], respectively. The positive and negative predictive values were 91.4% [95% CI (83.8, 96.2)] and 100.0% [95% CI (99.9, 100.0)], respectively. A total of 17 327 newborns were screened by dry salivary PCR assay and 74 were CMV positive, whereas 76 (0.4%) [95% CI (0.3, 0.5)] were rapidly CMV positive. The sensitivity and specificity for the dry saliva PCT assay were 97.4% [95% CI (90.8, 99.9)] and 99.9% [95% CI (99.9, 100.0)], respectively. The predicted positives and negatives were 90.2% [95% CI (81.7,95.7)] and 99.9% [95% CI (99.9,100.0), respectively]. Conclusions The detection of CMV infection by liquid saliva and real-time PCR assay of saliva during pregnancy is highly sensitive and specific and should be considered as a screening tool for neonatal CMV.