Project Details
Early Career
Status: Funded - Open
Development of a point-of-care wearable device for congenital cytomegalovirus screening in newborns
Summary
BACKGROUND: Infants born with congenital human cytomegalovirus (cCMV) infections can develop long-term hearing loss, vision loss, and neurodevelopment delay. In low and middle-income countries (LMICs), the prevalence of cCMV can be as high as 6-14% and at 20% among infants born to seropositive mothers. GAP: Prompt diagnosis is needed to diagnose and treat CMV appropriately in symptomatic neonates; however, PCR testing for cCMV currently requires shipment of samples to a centralized laboratory with unacceptably long turnaround times (>3 weeks) in most sub-Saharan African facilities. This study aims to address this unmet need of cCMV diagnostics by developing a novel point-of-care molecular test for screening congenital CMV infections that can provide accurate test results within the mother's delivery stay at the health facilities. HYPOTHESIS: Hypothesis 1: Our bench-top isothermal assay has ≥95% sensitivity and specificity when testing on a panel of purified DNA; Hypothesis 2: Our assay in a wearable device format can (i) be operated successfully using human body temperature around the wrist and yield the analytical sensitivity and specificity comparable to the bench-top version and (ii) be rated highly by key stakeholders in Kenya. METHODS: Our assay sensitivity and specificity will be assessed using a DNA control panel (40 CMV-positive and 40 CMV-negative). Non-infectious positive DNA (from diverse CMV sequences) and negative DNA (derived from other DNA sequences commonly found in human urine specimens) will be operated on a device worn by patient communities (i.e., newborns or caretakers). RESULTS: Pending. IMPACT: This project will enable primary development and evaluation of a point-of-care cCMV screening technology, and early engagement with local key stakeholders will help us to determine the “refined” format of the diagnostic device prototype to ensure smooth integration with the existing local clinical workflow and high acceptability by the patient community. Website Link: www.nuttadapanpradist.com