Development of a High Throughput Assay for Rapid Screening of Congenital Cytomegalovirus Infection using Dried Blood Spots - Project Summary
Sensorineural hearing loss (SNHL), a condition where the inner ear cannot convert sound into nerve impulses
to the brain, is the most common congenital disease. The leading cause of non-genetic SNHL is congenital
cytomegalovirus (cCMV) infection, and the economic burden of SNHL and its detrimental effect on language
development in the US is estimated at nearly $4 billion annually. Studies show that prompt antiviral therapy
can improve language development in children identified with hearing loss. However, the benefits of early
antiviral treatment are highly dependent on rapid diagnosis. If there are no saliva or urine samples available,
diagnosis of cCMV infection in children is only possible by examining Dried Blood Spots (DBSs) that are
routinely collected at birth. However, current DNA extraction methods exhibit lower sensitivity to detect CMV in
DBSs when compared to saliva and urine. Microgen’s One-Step® platform, which integrates sample lysis and
target amplification, is an innovative, low-cost, and user-friendly technology that can address this challenge.
The goal of this project is to develop an inexpensive ($10 each) and rapid (15-25 min from sample to result)
test for diagnosis of cCMV using DBSs, allowing immediate counseling and treatment. Development of
Microgen’s One-Step® CMV DBS test will provide a new tool for diagnosis, especially in asymptomatic
patients with delayed hearing loss.
