BACKGROUND In recent years, interest in universal newborn screening for congenital cytomegalovirus (cCMV) has intensified. consequently, reliable and simple methods of mass screening for cCMV, are essential. Herein, we present a novel approach of using polymerase chain reaction (PCR) in saliva with direct inoculation onto Guthrie paper. Our aim was to determine the diagnostic accuracy of real- time PCR in saliva rolled directly onto Guthrie paper in diagnosing cCMV infection. OBJECTIVES To evaluate the diagnostic accuracy of real-time PCR analysis of dried saliva on Guthrie paper as a future approach for mass screening of newborns in diagnosing cCMV infection. STUDY DESIGN This prospective, blinded study was performed in a tertiary cytomegalovirus (CMV) clinic from May 2018 through January 2019. Forty-two cCMV positive newborns and 41 without cCMV, were enrolled and tested for CMV using PCR from their saliva placed onto Guthrie paper and from their saliva using standard methods. Specificity and sensitivity of dried saliva PCR versus gold-standard methods were analyzed. RESULTS Forty-two out of 42 (100 %) CMV positive infants showed positive PCR in the dried saliva on the Guthrie paper. All (100 %) controls exhibited negative PCR results. Congenital CMV infection was identified with a sensitivity of 100 % (95 % C.I. = 91.4%-100.00%) and specificity of 100 % (95 % C.I. = 91.4%-100.00%). DISCUSSION CMV testing with saliva real-time PCR on Guthrie paper displayed a high sensitivity and specificity, rendering it a powerful screening test. The accuracy, simplicity of sampling, storage and transportation and the potential reliance on existing logistic resources, establishes this method as a candidate for cCMV universal screening programs.

中文翻译：

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在Guthrie论文上通过唾液诊断先天性巨细胞病毒。

背景技术近年来，对先天性巨细胞病毒（cCMV）的通用新生儿筛查的兴趣增强了。因此，可靠且简单的cCMV大规模筛查方法至关重要。在这里，我们提出了一种直接在Guthrie纸上接种的唾液中使用聚合酶链反应（PCR）的新颖方法。我们的目的是确定直接卷在Guthrie纸上的唾液中实时PCR的诊断准确性，以诊断cCMV感染。目的评估在Guthrie纸上实时分析唾液干PCR的诊断准确性，作为将来对新生儿进行大量筛查以诊断cCMV感染的方法。研究设计该前瞻性，双盲研究于2018年5月至2019年1月在第三级巨细胞病毒（CMV）诊所进行。招募了42例cCMV阳性新生儿和41例没有cCMV的新生儿，并使用PCR方法从放置在Guthrie纸上的唾液和使用标准方法的唾液进行了PCR检测。分析了干唾液PCR相对于金标准方法的特异性和敏感性。结果42名（100％）CMV阳性婴儿中有42名在Guthrie纸上的干燥唾液中显示阳性PCR。所有（100％）对照均显示阴性PCR结果。先天性巨细胞病毒感染的敏感性为100％（95％CI = 91.4％-100.00％），特异性为100％（95％CI = 91.4％-100.00％）。讨论在Guthrie纸上使用唾液实时PCR进行CMV测试显示出高灵敏度和特异性，使其成为功能强大的筛选测试。准确性高，采样简单，