Combining rapid antibody and RNA tests to optimise Hepatitis C testing in Australia

Hepatitis C (HCV) testing is a complex process and requires healthcare practitioners to utilise HCV RNA diagnostics tests to distinguish between prior and active HCV infections. Identifying active HCV infections is critical to limiting the spread of the virus and ensuring that individuals are receiving the necessary treatment to reduce their viral load.

The elimination of hepatitis C as a major public health threat by 2030 is a key goal of the World Health Organization Global Health Sector Strategy on Viral Hepatitis and the Australian National Hepatitis C Strategy. However, achieving hepatitis C elimination will require increased testing for current hepatitis C infection says Jason Grebely, a Professor at the Kirby Institute, UNSW Sydney.

“If we don’t increase testing for active infection by 50%, we’re going to run out of diagnosed people, and nobody left to treat. So, we really need to increase more Hep C testing to diagnose more people and then to engage them in care,” he said.

The standard diagnosis pathway for HCV infection is typically a multistep process – an initial visit to a doctor, followed by an antibody blood test. The sample is then transported to a central lab where testing is done, and results are received by the doctor in a few days. The patient then needs to return to the same doctor for a diagnosis, where more blood tests are ordered to confirm whether the infection is active.

“Given the long journey from initial testing to diagnosis for patients, it is not surprising that there is considerable loss to follow-up along the cascade of care for hepatitis C, particularly in key populations such as people who inject drugs and people in prison,” Professor Grebely affirmed.

The recent approval of the fingerstick point-of-care RNA test for detection of active HCV infection in one hour at the point-of-care has changed the clinical management of hepatitis C infection. Point-of-care HCV RNA testing allows diagnosis and treatment in a single visit, increases testing acceptability, and reduces loss to follow-up. This technology is particularly useful in settings with a high prevalence of HCV infections. However, point-of-care HCV RNA testing is more expensive than point-of-care HCV antibody testing and has a longer time to result.

“Combining point-of-care HCV antibody and RNA testing could optimise testing, enhancing cost-effectiveness and patient acceptability with no impact on effectiveness,” Professor Grebely stated.

As such, in settings with a lower HCV infection prevalence, it may be preferable to utilise rapid HCV antibody tests prior to HCV RNA testing. Abbott has recently developed rapid antibody tests for the qualitative detection of antibodies specific to HCV, which are being piloted in point-of-care settings.

Combining the use of point-of-care HCV antibody and HCV RNA tests could provide optimise current point-of-care hepatitis C testing programs, improving the efficiency of  HCV testing programs such as the new point-of-care testing (POCT) announced in September last year led by the Kirby Institute at UNSW Sydney and the International Centre for Point-of-Care Testing at Flinders University. Professor Grebely is leading the program, which plans to test 50-60,000 people over the next 2-3 years at more than 80 testing sites nationally, including drug treatment clinics, needle and syringe programs, prison sites, mental health services, mobile outreach models, homelessness services, and Aboriginal and Torres Strait Islander community-controlled health organisations.

Professor Grebely is hoping the pilot will result in the scale-up of point-of-care testing nationally and internationally, having an impact on clinical practice and policy.

“I think it's really going to change our models of care for hepatitis C for the better. We have a very supportive Commonwealth Government, and all the stakeholders are just so engaged including the affected community, healthcare providers, the government, and researchers. I think it's an exciting innovation and provides an opportunity to scale-up HCV testing,” Professor Grebely concluded.

Abbott Rapid Diagnostics’ Point-of-Care Rapid Antibody test is not registered for use in Australia.