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

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.