Objective
To determing the utility of dried blood spot (DBS) PCR in identifying infants with cytomegalovirus infection (CMV)-associated sensorineural hearing loss (SNHL).
Study design
Newborns at 7 U.S. hospitals from March 2007-March 2012 were screened for CMV by saliva rapid culture and/or PCR. Infected infants were monitored for SNHL during the first 4 years of life to determine sensitivity, specificity, positive and negative likelihood ratios of DBS PCR for identifying CMV-associated SNHL.
Results
DBS at birth was positive in 11/26 (42%) children with SNHL at 4 years of age and 72/270 (27%) children with normal hearing (p=0.11). The sensitivity (42.3%, 95% CI 23.4%–63.1%) and specificity (73.3%, 95% CI, 67.6%–78.5%) was low for DBS PCR in identifying children with SNHL at 4 years of age. The positive and negative likelihood ratios of DBS PCR positivity to detect CMV-associated SNHL at 4 years of age were 1.6 (95% CI, 0.97–2.6) and 0.8 (95% CI, 0.6–1.1), respectively. There was no difference in DBS viral loads between children with and without SNHL.
Conclusions
DBS PCR for CMV has low sensitivity and specificity for identifying infants with CMV-associated hearing loss. These findings together with previous reports demonstrate that DBS PCR neither identifies the majority of CMV-infected newborns nor those with CMV-associated SNHL early in life.
Real-time polymerase chain reaction (PCR) of saliva is highly sensitive for newborn congenital cytomegalovirus (CMV) screening. This study uses nationally published CMV seroprevalence and breastfeeding rates to estimate the contribution of CMV DNA in breast milk to false-positive saliva PCR results. The false-positive rates adjusted for breastfeeding ranged from 0.03% in white Hispanic persons to 0.14% in white non-Hispanic persons. Saliva CMV PCR for newborn screening is highly sensitive, and the low false-positive rates in this study suggest that saliva PCR results are unlikely to be significantly influenced by breastfeeding or other perinatal exposures.
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