A Rapid Multiplexed Assay for the Diagnosis of Viral Hepatitis at the Point of Care

Abstract InstadiagnosticsIDIis developing a point of carePOCdiagnostic technology platform with the goal of providing early detectionscreeningand treatment monitoring for patients at primary care centerscommunity clinicsurgent care centersand emergency departmentsThe device consists of a portable readerthe InstaReaderand disposable cartridgesInstaCartridgeA range of disease specific cartridges will allow for multiple diseases be detected on a single deviceThe systemandapos s ability to provide clinical laboratory quality results in less thanminutes will give medical workers the capability to immediately diagnose patientsand allows patients to avoid additional trips to have blood drawnlengthy wait times for resultsor delays in diagnosis and follow up testingIDIandapos s diagnostic platform will improve patient care satisfactionmedical outcomesand workflow for healthcare providerswhile reducing overall medical costsIn response to the call for proposals issued by the National Center for HIV AIDSViral HepatitisSTDand TB Preventionthe goal of the proposed work is to develop a rapid multiplexed blood test for point of care evaluation of patients at risk for viral hepatitisspecifically hepatitis C virusHCVand hepatitis B virusHBVIt is estimated thatmillion andAmericans have chronic HCV and HBV infectionsrespectivelyand the rate of new HCV infections has increased further in recent yearsChronic HBV and HCV infections are treatable for nearly all patients and treatments result in significant reductions in liver related morbidity and mortalityTreatments are most effective and cost effective when initiated early in the disease coursebefore cirrhosis is presentHowevertwo thirds of people with HBV and half of those with HCV are unaware of their infections and therefore not referred for treatment evaluationA known barrier to screening is the accessibility to testing labs and or POC testsThereforean improvedreadily available method of screening high risk individuals for chronic viral hepatitis at the POC is essential to improve prognosis for infected individualsThe specific aims of the proposed Phase I SBIR project are toCollect HCVand HCVpatient samples and develop an assay for detection of antibodies to HCVusing our sensor technologyValidate the HCV assay using samples of human plasma from seroconversion panels In Phase IIbiomarkers for HBV will be added to the HCV cartridge developed in Phase IAdditional test panels will then be expanded to include one or more HIVsyphilisgonorrheaand or TB markers Instadiagnosticsandaposproject will result in a point of care test for blood borne viral hepatitis biomarkers aimed at the rapid diagnosis of infectious diseasesspecifically hepatitis B and Cthat are commonly comorbid with HIV infectionsThis test will facilitate the improved surveillance of high risk patients and populationsand is expected to result in improved treatment outcomes due to the timely diagnosis of the diseaseIt will be especially beneficial to patients in low income settings wherein the cost of healthcaremissed workdaysand lack of transportation can be substantial barriers to regular testing in centralized laboratories