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Subject: TRADITIONAL 'HEEL STICK' TEST IS NOT AN EFFECTIVE SCREENING TOOL
FOR CMV IN NEWBORNS

U.S. Department of Health and Human Services 
NATIONAL INSTITUTES OF HEALTH NIH News 
National Institute on Deafness and Other Communication Disorders (NIDCD)
<http://www.nidcd.nih.gov/>
Embargoed for Release: Tuesday, April 13, 2010, 4 p.m. EDT

CONTACT: Jennifer Wenger, 301-496-7243, <e-mail:[log in to unmask] >

TRADITIONAL 'HEEL STICK' TEST IS NOT AN EFFECTIVE SCREENING TOOL FOR CMV IN
NEWBORNS

A routine screening test for several metabolic and genetic disorders in
newborns, the heel-stick procedure, is not effective in screening for
cytomegalovirus (CMV) infection, a leading cause of hearing loss in
children, according to research published in the April 14 online issue of
the Journal of the American Medical Association. 

About 20,000-30,000 infants are born infected with CMV each year, 10-15
percent of whom are at risk for eventually developing hearing loss.

The study, funded by the National Institute on Deafness and Other
Communication Disorders (NIDCD), one of the National Institutes of Health,
is part of a multicenter research project headed by the University of
Alabama at Birmingham that is seeking to find the most effective screening
test for CMV infection in newborns. The standard method for detecting CMV
infection in newborns is labor-intensive and not conducive to a widespread
screening program. 

"The heel-stick test is a simple test that is already being used to screen
for other diseases in newborns across the United States, so it seemed like a
good candidate for a possible universal screening program for CMV," said
James F. Battey, Jr., M.D., Ph.D., director of the NIDCD. "However, these
findings show us that, at least with current technologies, the heel-stick
test should not be used as a primary newborn screening tool for CMV."

CMV is the most common infection passed from a mother to her unborn child.
The vast majority of CMV-infected babies show no initial symptoms, and many
babies will never develop health problems. But in some CMV-infected babies,
serious problems can develop over time. Hearing loss is the most common
deficit to emerge later on. The earlier doctors can identify CMV infection,
the better they can monitor a child's hearing. If signs of hearing loss are
present, appropriate intervention should be provided as soon as possible.

Between March 2007 and May 2008, the researchers analyzed dried blood
samples obtained using the heel-stick procedure from babies born at the
University of Alabama at Birmingham, and six other participating medical
centers across the United States. The heel-stick procedure involves pricking
a newborn's heel, drawing a small amount of blood, and placing the blood on
filter paper to dry so that it can be analyzed for several diseases,
including hypothyroidism and sickle cell disease. 

To test for CMV infection, the researchers removed the babies' DNA from the
filter paper and then used a common molecular diagnostic technique to
quickly and efficiently detect whether any CMV DNA was mixed in. The
procedure, called real-time polymerase chain reaction, or PCR, uses special
molecules, called primers, to seek out a tell-tale portion of CMV DNA and
churn out lots of fluorescent copies of that segment so it can be easily
detected. For the initial group of babies, the researchers used a single set
of primers targeting one section of CMV DNA. As the study progressed, they
added a second primer set targeting an additional section in hopes of
increasing accuracy, or sensitivity, of the test. 

The team also compared their results to the standard method of detecting CMV
in newborns. CMV rapid culture is a highly effective procedure that uses
saliva or urine instead of dried blood samples to make the identification.
The rapid culture method is labor-intensive and requires a tissue culture
facility on site, so it would be difficult to adapt this technology to a
widespread screening program. 

Many studies have found that dried blood spot PCR is able to identify babies
with congenital CMV infection, so some researchers have suggested that it be
used for a universal screening program. However, none of the earlier studies
compared dried blood spot PCR results to the rapid culture method and
therefore could not determine if the PCR procedure was as good as the
standard or if it fell short and missed truly infected babies or falsely
identified babies as being CMV-infected when they were not infected. 

In this study, 20,448 babies were screened, 92 of whom were confirmed to
have congenital CMV infection. The rapid culture method identified 91 of the
92 infants, for nearly 100 percent sensitivity. For the 11,422 infants who
were screened with the single-primer PCR assay derived from dried blood
spots, only 17 out of 60 infected children were identified, a 28.3 percent
sensitivity. Of the 9,026 infants who were screened with the two-primer PCR
method, 11 out of 32 infected children were identified, a sensitivity of
34.4 percent. 

"In order to be included as part of a screening test, the minimum
sensitivity should be at least 95 percent," said Suresh Boppana, M.D., a
co-principal investigator on the study with Karen Fowler, Ph.D., both of
whom are with the University of Alabama at Birmingham. "Our findings
indicate that dried blood spot PCR will only detect 30-40 percent of babies
with CMV infection. More than half of babies who are infected would be
missed."

The researchers are now assessing whether analysis of saliva samples using
real-time PCR technology can do a better job than dried blood spots when
compared with the rapid culture method. They believe that the use of saliva
may be beneficial since babies with congenital CMV infection are known to
have a lot of virus in their saliva, compared to the blood, where amounts
can vary depending on when the infant was infected during development. In
addition, saliva samples require minimal processing and are noninvasive.

Other participating institutions are Saint Peter's University Hospital, New
Brunswick, N.J.; University of Mississippi Medical Center, Jackson;
Carolinas Medical Center, Charlotte, N.C.; University of Pittsburgh and the
Children's Hospital of Pittsburgh; University of Texas Southwestern Medical
Center, Dallas; and University of Cincinnati and Cincinnati Children's
Hospital Medical Center.

NIDCD supports and conducts research and research training on the normal and
disordered processes of hearing, balance, smell, taste, voice, speech and
language and provides health information, based upon scientific discovery,
to the public. For more information about NIDCD programs, see the Web site
at www.nidcd.nih.gov.

The National Institutes of Health (NIH) -- The Nation's Medical Research
Agency -- includes 27 Institutes and Centers and is a component of the U.S.
Department of Health and Human Services. It is the primary federal agency
for conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and its programs,
visit <www.nih.gov>.


###


This NIH News Release is available online at:
<http://www.nih.gov/news/health/apr2010/nidcd-13.htm>.

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