Point-of-care magnetofluidic HCV diagnostic using thermally responsive valves

NIH RePORTER · NIH · R01 · $401,791 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY Hepatitis C kills over a million people each year, more than Tuberculosis or HIV. To eradicate the Hepatitis C epidemic, a dramatic shift in diagnostics methodology is needed. The current paradigm, which relies on lab- based tests, requires multiple visits with a patient because of the latency between sample collection and result. This is challenging for at-risk populations and is sometimes impossible in low- and middle-income countries (LMICs). Moreover, central lab diagnostic technologies are simply not available in some LMICs. To address this technology gap, we will develop a low-cost, portable, fully automated Sample-To-Answer Test for Hepatitis C Virus (STAT-HCV). The STAT-HCV, which consists of a disposable cassette, a lateral flow strip, and a low- cost handheld control unit, is enabled by our invention of Thermally Responsive Alkane Partitions (TRAPs), pseudo-valves that automate precise sample manipulation steps. This innovation eliminates manual rinses and the precise addition of reagents. The novel STAT-HCV design uniquely integrates TRAPs to achieve a low- cost and portable diagnostic that will detect and genotype active Hepatitis C infections in blood collected directly from patients’ fingertips. Successful outcomes will achieve a low-cost, rapid, portable, and easy-to-use diagnostic with sensitivity and specificity values that match gold-standard commercial lab-based genomic tests. This will lead to a new sample-to-answer diagnostic approach that supports eradication of the Hepatitis C epidemic and that can be broadly applied to point-of-care diagnostics of any bloodborne viral infection.

Key facts

NIH application ID
10803461
Project number
1R01AI176197-01A1
Recipient
UNIV OF MARYLAND, COLLEGE PARK
Principal Investigator
Ian M White
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$401,791
Award type
1
Project period
2024-03-01 → 2028-01-31