Rapid diagnostic to determine CMV serological status

The goal of this project is to develop a diagnostic that can support the enrollment of seronegative individuals in clinical trials of candidate cytomegalovirusCMVvaccinesCongenital CMV infection is one of the leading causes of non genetic birth defects worldwideIf a successful vaccine can be brought to marketit will have a significant impact on the number of babies born with hearing and vision lossintellectual impairmentsmall head size and other neurological disordersA lateral flow rapid test diagnostic was developed that detects both IgG and IgM response to the presence of the virusThe test uses gold nanoshells as the reporter particles to achieve the required high level of sensitivityIn an initial study withclinical samples using the Phase I prototypeasensitivity andspecificity was obtainedThe lateral flow test format is inexpensivesimple to operaterequires only fingerstick blood samplingand has multi year stability without refrigerationA visual signal is obtained in less thanminutes allowing for same visit diagnosis and enrollment of candidate CMV vaccine trial subjects