Saliva Polymerase-Chain-Reaction Assay for Cytomegalovirus Screening in Newborns

Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL 35233, USA.
New England Journal of Medicine (Impact Factor: 55.87). 06/2011; 364(22):2111-8. DOI: 10.1056/NEJMoa1006561
Source: PubMed


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.).

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Available from: April L Palmer, Apr 07, 2014
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    • "However, it can cause serious, often life-threatening complications in immunocompromised individuals, including solid organ and cell transplant recipients, AIDS patients, and patients suffering from late stage cancers (reviewed by Mercorelli [1]). Above all, congenital HCMV infection of immunologically immature fetuses is the most common viral cause of birth defects, affecting 0.1–0.3% of newborns [2], [3]. "
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    • "Studies have shown that some of the components in saliva can be used as biomarkers for diagnosis. Real-time PCR assays of both liquid and dried saliva specimens showed high sensitivity and specificity for detecting cytomegalovirus infection, suggesting their potential as screening tools for cytomegalovirus infection in newborns [9]. Zerr et al.[10] developed a noninvasive method for testing serially-collected saliva specimens for human herpesvirus-6, and applied this method prospectively in children from birth to 2 years of age to determine the pattern of acquisition and natural history of human herpesvirus-6 infection. "
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