Point-of-Care Nucleic Acid Test for Cytomegalovirus for Newborn Hearing Screening

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DESCRIPTION (provided by applicant): Universal newborn hearing screening is mandated in the US and is performed in the postpartum hospital setting. Current physiology-based hearing screening tests are unable to detect late-onset hearing loss caused by cytomegalovirus (CMV) infection. Therefore, a complementary screening approach has been suggested to prevent disabilities associated with CMV-related hearing loss by early detection and intervention. A nucleic acid test has been described to screen newborns for congenital CMV infection using saliva specimens where it is more sensitive than the dried blood spots traditionally used by the newborn screening laboratories. Newborn screening programs do not have the infrastructure necessary to use newborn saliva samples and molecular assays. Advanced Liquid Logic's digital microfluidic technology is a recognized innovative, low-cost, and automated liquid handling system that can address this challenge. The objective of this Fast-Track application is to develop an integrated lab-on-a-chip to perform screening of congenital CMV infection in newborns using saliva samples. Specific aims in Phase I are to develop protocols for CMV purification from saliva samples and for viral DNA amplification on-cartridge, and to integrate a "sample-to-answer" CMV screening assay on the digital microfluidic platform. Success in Phase I will result in a Phase II continuation where the specific aims will be (i) to develop a point-of-care newborn screening platform, (ii) to optimize the "sample-to-answer" CMV protocol in this platform and assess its analytical performance, and (iii) to perform a method comparison with the "gold standard" rapid saliva culture using neonatal saliva samples in collaboration with the University of Alabama at Birmingham.