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Clinical Trial
. 2011 Jun 2;364(22):2111-8.
doi: 10.1056/NEJMoa1006561.

Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns

Suresh B Boppana  1 , Shannon A Ross, Masako Shimamura, April L Palmer, Amina Ahmed, Marian G Michaels, Pablo J Sánchez, David I Bernstein, Robert W Tolan Jr, Zdenek Novak, Nazma Chowdhury, William J Britt, Karen B Fowler; National Institute on Deafness and Other Communication Disorders CHIMES Study
Collaborators, Affiliations
Clinical Trial

Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns

Suresh B Boppana et al. N Engl J Med. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Enrollment and Prospective Screening of 34,989 Newborns
CMV denotes cytomegalovirus, and PCR polymerase chain reaction.
See this image and copyright information in PMC

Comment in

References

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