Making hepatitis C testing accessible where it’s needed most
Hepatitis C virus (HCV) infection is often asymptomatic in its early stages, so many people are unaware they live with the virus. Access to confirmatory molecular testing remains limited in remote, correctional and low-resource healthcare settings.
Rapidly expanding access to testing is essential to closing the persistent gap between diagnosis and initiating highly effective curative treatments that can reduce morbidity and mortality.
To help address this challenge, ZiP Diagnostics and Burnet Institute have developed a rapid molecular point-of-care test for HCV RNA detection.
In an evaluation of 200 clinical samples, the rapid test achieved 97% sensitivity and 100% specificity. The innovative test works directly from whole blood, with no plasma processing required, and typically returned results within 10-25 minutes, including at low viral loads below 10,000 IU/mL.
Enabled by support from the NHMRC Development Grant scheme, the test uses RT-LAMP isothermal amplification technology and runs on the Australian-made ZiP-P2 point-of-care platform.
“The ability to confirm active HCV infection rapidly and accurately at the point of care — without depending on laboratory infrastructure — addresses one of the most significant practical barriers to treatment access and, ultimately, to elimination,” says Associate Professor Jack Richards, Infectious Diseases Physician and CEO of ZiP Diagnostics.
Dr George Taiaroa (Senior Research Officer) at Zip Diagnostics says the collaboration set out to build a test that maintains gold-standard performance and closes the gap in underdiagnosis. “Getting this level of sensitivity and specificity from whole blood is a strong sign that our test can support routine clinical use,” he says.
These findings represent a meaningful step toward field-deployable molecular HCV diagnostics that could support expanded testing in community and resource-limited settings.
Despite the availability of effective treatments since the mid-2000s, more than 60,000 people in Australia live with the HCV infection, with Aboriginal and Torres Strait Islander people bearing a disproportionate burden, making up almost 1 in 5 cases [1]. Globally, the prevalence of HCV infection is estimated at 47 million people [2].
“Achieving global HCV elimination targets will require substantial expansion of testing capacity in settings that are currently underserved by conventional diagnostic infrastructure,” says Professor Heidi Drummer, Burnet Institute’s Scientific Director for Research Translation and the Burnet Diagnostics Initiative. “Point-of-care molecular diagnostics represent an important tool in this effort. The clinical validation results from this collaboration are encouraging and underscore the value of translational research partnerships in advancing diagnostic equity.”
ZiP Diagnostics and Burnet Institute acknowledge funding support from the NHMRC.
