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Rapid point-of-care molecular test for HCV VL

HCV VL 快速护理点分子检测

基本信息

批准号：
10330833
负责人：
Jay Kenneth Fisher
金额：
$ 28.87万
依托单位：
REDBUD LABS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10330833
关键词：
5&apos Untranslated Regions Affect Algorithms Antibodies Antiviral Agents Biological Assay Blood Chemistry Cirrhosis Clinic Visits Cold Chains Comprehensive Health Care Detection Development Devices Diagnosis Diagnostic Diagnostic tests Diffusion Digit structure Disease Electricity Environment Exposure to Fluorescence Funding Future Genotype Goals Gold HCV screening HIV HIV-1 Hepatitis B Virus Hepatitis C Hepatitis C Antibodies Hepatitis C Prevalence Hepatitis C Therapy Hepatitis C virus High Prevalence Individual Infection Inflammatory Kinetics Laboratories Letters Liver Failure Liver diseases Methods Microfluidic Microchips Microfluidics Molecular Nucleic Acid Amplification Tests Nucleic Acids Oranges Patients Performance Phase Polymerase Population Populations at Risk Preparation Primary carcinoma of the liver cells Production Quantitative Reverse Transcriptase PCR Reagent Resources Rest Routine Diagnostic Tests Running Sampling Sensitivity and Specificity Specificity Specimen System Technology Testing Tube Viral Load result Viremia Vulnerable Populations Work amplification detection antibody test assay development base comorbidity cost design detection limit diagnostic assay follow-up isothermal amplification magnetic beads nucleic acid purification phase 2 study point of care programs recombinase risk minimization scale up success treatment strategy

项目摘要

ABSTRACT Hepatitis C, the inflammatory liver disease caused by hepatitis C virus (HCV), claims approximately 400,000 lives each year from secondary hepatocellular carcinoma and cirrhosis-induced liver failure. Direct-acting antiviral agents can cure > 95% of the estimated 71 million cases of hepatitis C found globally, yet because of underdiagnosis, only 7% of patients are currently receiving treatment. The diagnostic testing algorithm for HCV necessitates multiple clinic visits. Individuals in vulnerable populations often lack the means to meet this high follow-up burden. Increasing the prevalence of HCV treatment to reflect the 95% cure rate requires simplification of diagnostic testing. To this end we will develop a sample-to-answer HCV viral load (VL) test that meets or exceeds the minimal acceptable criteria as defined by the hepatitis C global stakeholder consortium. To achieve this goal, we will combine Redbud Labs’ expertise in microfluidics and systems with the diagnostic assay development expertise of the Diagnostics Program at PATH (Seattle, WA). In Aim 1 Redbud Labs will optimize each assay step to the microfluidic environment using Redbud technologies and commercially available reagents. In Aim 2 PATH will design assay primers and probes. In Aim 3 Redbud Labs will validate the assay by performing it end-to-end using a breadboard system. Redbud technologies are production-ready, which will minimize the risk of degradation in assay performance as we move through cartridge integration in future Phase II work.

摘要