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 ($25 each) and rapid (30 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.