The number of people testing positive for hepatitis C virus (HCV) has increased significantly in the last decadeand younger adults contracting the virus has become more common. Now, roughly 50,000 infections areexpectedeach year and about 40% of the people are not aware of their infections. Although, about half of theseacute infections can be cleared by the individual, the remainder will become chronically infected. If hepatitis C isundiagnosed and remains untreated, severe liver damage and death can occur. HCV related liver damage isnow a leading cause of death in the U.S., claiming ~15,000 lives annually. Although no vaccine for HCV iscurrently available, effective anti-retroviral treatment does exist to treat the disease with over 95% cure rate.Hence, identifying people with hepatitis C (chronic infection) is a critical task to treat and stop the spread of HCV.Currently, screening and diagnosing active HCV infection requires two tests. One antibody test to determineprior exposure and one nucleic acid test (NAT) to confirm an active infection. However, this two-step procedureis cumbersome and heavily relies on clinical laboratories; additionally, the antibody is not sensitive in the firsttwo months of a new HCV infection and missing these cases. Hence, the current testing procedure has becomethe bottleneck for screening hepatitis C. Besides the current two-step approach, HCV core antigen (cAg) test has been proposed as an equally effectiveapproach for screening and diagnosing active HCV infections. Numerous clinical studies since the 2000s havedemonstrated a highly sensitive cAg test can be used to screen active HCV infection as effectively as NAT.However, all currently available HCV cAg test can only be performed in a laboratory setting and require trainedpersonnel for operation and maintenance. As a result, this Phase I project is proposed to demonstrate thefeasibility of developing a highly sensitive cAg test that can be performed quickly and accurately at the point-of-care (POC) by utilizing a detection platform based on the existing Blood Glucose Meter (BGM) hardware and adisposable microfluidic assay cartridge. Today's BGM is the culmination of decades of R&D, designed for smallfootprint, simple operation, low cost and large-scale production. Leveraging the BGM technology with a familiarassay format for new applications allows us to reduce the risk and costs associated with device developmentand scale-up production. The final product will be a POC system composed of a BGM based meter anddisposable cartridges for HCV cAg for measuring cAg levels in high risk individuals. The new POC HCV cAg testwill be able to quickly identify individuals with chronic HCV infection and allow early curative treatment. Theproposed product will also greatly benefit developing countries with high HCV prevalence but lacking testinginfrastructure. The project will include three development goals, including 1) develop and optimize a highly sensitive cAgtest using the BGM platform; 2) validate the BGM based cAg test in biological samples; and 3) integrating theoptimized assay with an existing prototype system. Project Narrative Hepatitis C is on the rise again in the United States and worldwide. Although effective treatment is available, the current two-step testing procedure is too cumbersome to screen large number of individuals at risk or those unaware of his or her infection to initiate treatment. In this Phase I project, we proposed to develop a rapid easy- to-use and affordable test for hepatitis C virus (HCV) core antigen to allow fast screening for active HCV infection at the point-of-care. Adult ; 21+ years old ; Adult Human ; adulthood ; Amino Acids ; aminoacid ; Antibodies ; Antigens ; immunogen ; Viral Antigens ; virus antigen ; Biological Assay ; Assay ; Bioassay ; Biologic Assays ; Blood Glucose ; Blood Sugar ; Buffers ; Malignant Neoplasms ; Cancers ; Malignant Tumor ; malignancy ; neoplasm/cancer ; Cause of Death ; Centers for Disease Control and Prevention (U.S.) ; CDC ; Centers for Disease Control ; Centers for Disease Control and Prevention ; United States Centers for Disease Control ; United States Centers for Disease Control and Prevention ; Clinical Research ; Clinical Study ; Cessation of life ; Death ; Developing Countries ; Developing Nations ; Less-Developed Countries ; Less-Developed Nations ; Third-World Countries ; Third-World Nations ; Under-Developed Countries ; Under-Developed Nations ; developing country ; developing nation ; Diagnosis ; Disease ; Disorder ; viral DNA ; virus DNA ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Epidemic ; Glucose ; D-Glucose ; Dextrose ; Goals ; Hepatitis C ; HCV infection ; Hepatitis C virus infection ; Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted ; Hepatitus C ; hep C ; hepatitis non A non B ; non A, non B hepatitis ; non-A, non-B hepatitis ; Immunoassay ; Infection ; Laboratories ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Liver diseases ; Hepatic Disorder ; hepatic disease ; hepatopathy ; liver disorder ; Maintenance ; Nucleic Acids ; Production ; Quality of life ; QOL ; research and development ; Development and Research ; R & D ; R&D ; Risk ; Societies ; Technology ; Testing ; Time ; United States ; Virus ; Measures ; Price ; pricing ; Healthcare ; health care ; Step Tests ; Custom ; Hepatitis C Antibodies ; Anti-HCV Antibodies ; Anti-Hepatitis C Virus Antibodies ; HCV Antibodies ; Hepatitis C Virus Antibodies ; base ; Blood specimen ; Blood Sample ; improved ; Procedures ; Nucleic Acid Amplification Tests ; Nucleic Acid Testing ; Area ; Chronic ; Clinical ; Phase ; Biological ; Medical ; Training ; Renal function ; kidney function ; Individual ; young adult ; adult youth ; young adulthood ; Early Intervention ; Point-of-Care Systems ; Contracting Opportunities ; Contracts ; Life ; System ; meter ; Viral ; Chronic type C viral hepatitis ; Chronic viral hepatitis C ; chronic HCV infection ; chronic hepatitis C virus infection ; Chronic Hepatitis C ; Performance ; success ; virus core ; Antiretroviral Agents ; anti-retroviral ; antiretroviral ; Anti-Retroviral Agents ; Manpower ; personnel ; Human Resources ; molecular diagnostic assays ; Molecular Diagnostic Testing ; Sampling ; assay development ; glucometer ; glucose meter ; glucose monitor ; Intervention Strategies ; interventional strategy ; Intervention ; µfluidic ; Microfluidics ; device development ; instrument development ; Device or Instrument Development ; Improve Access ; Validation ; Process ; follow-up ; Active Follow-up ; active followup ; follow up ; followed up ; followup ; Development ; developmental ; point of care ; Cirrhosis ; cirrhotic ; antiretroviral therapy ; anti-retroviral therapy ; anti-retroviral treatment ; antiretroviral treatment ; cost ; healing ; design ; designing ; Hepatitis C Vaccine ; HCV Vaccine ; hepatitis C virus vaccine ; Hepatitis C Prevalence ; HCV Prevalence ; hepatitis C virus prevalence ; scale up ; Population ; HCV screening ; Hepatitis C virus screening ; prototype ; high risk ; effective therapy ; effective treatment ; large scale production ; operation ; screening ; liver injury ; Injury to Liver ; hepatic damage ; hepatic injury ; liver damage ; curative treatments ; curative intervention ; curative therapeutic ; curative therapy ; Hepatitis B Virus ; HBV ; Homologous Serum Hepatitis Virus ; Hepatitis C virus ; HCV ; chronic infection ; persistent infection ; acute infection ; Infrastructure ; infection rate ; rate of infection ; vaccine access ; access to vaccination ; access to vaccines ; vaccination access ; vaccination availability ; vaccine availability ; antibody test ; antibody based test ; antigen test ; antigen based test ; Rapid screening ; detection limit ; detection platform ; detection system ; point of care testing ;
