Projects

Liver health screening test

A rapid point-of-care (POC) test for liver disease biomarkers could improve the management of acute and chronic liver disease in Australia and worldwide. The test allows for immediate detection of liver injury and routine observation of liver health. As a simple screening test that could be performed by health workers in community settings for liver inflammation of any cause, it could prompt further investigations for underlying liver disease before major liver damage occurs.

Objective

The study’s primary objective is to expand on our initial prototype and develop a rapid point-of-care diagnostic test to assess liver health via a core diagnostic biomarker. Alanine aminotransferase (ALT) is a key indicator of liver injury. Measurement of ALT levels, namely the liver-specific isoform ALT1, is critical to liver disease diagnosis, monitoring and evaluation of treatment.

This test could be used to identify liver dysfunction in chronic conditions such as viral hepatitis (B or C) or fatty liver disease via routine monitoring. It could also be used as a companion diagnostic to help inform practitioners when prescribing medication with potential hepatotoxic side effects.

This test is also applicable to acute conditions such as drug-induced liver injury (DILI). With this injury, a rapid rise in ALT levels is observed necessitating urgent intervention to prevent long-term liver damage. By developing a rapid and cost-effective liver health check tool, we aim to broaden accessibility to routine health monitoring in patients experiencing chronic illness.

We also aim to facilitate prompt identification of liver injury where immediate intervention may be required.

Timeline

2021–ongoing.

Approach

Our first prototype demonstrated the feasibility of a simple, easy-to-use diagnostic tool that could successfully identify pathologically indicative ALT levels. The tool would alert users to a probable liver injury and allow for medical intervention.

Expanding on the success of our first-generation test, we have since optimised our prototype. The test now closely models a dose-response curve that will allow for the accurate quantification of ALT levels in real time. This will provide healthcare workers with a value for a more precise interpretation of liver health status.

We have refined our lateral flow technolog. It now includes high-yielding biologics with increased selectivity for the ALT1 isotype and reagents optimised for scalable manufacturing.

In 2024 our test was customised for use in the AtomoRapid Pascal device. This is a fully integrated cassette in a user-friendly design that provides rapid results. It contains a lancet, a blood collection device and a built-in running buffer release pack.

Community impact

Liver disease is routinely diagnosed by measuring ALT levels in the blood. Elevated ALT levels can be due to acute liver injury through drug toxicity and alcohol consumption. Such levels can also be a result of chronic conditions such as viral hepatitis (B or C) or fatty liver disease.

Due to the liver’s role in the metabolism and detoxification of therapeutic drugs, important medications may also be implicated in progressive liver injury. This is critical in chronic conditions where treatment is continuous and damage may accumulate.

Developing a rapid, on-the-spot test that bypasses the need for laboratory testing is crucial in allowing practitioners to make informed and immediate decisions. It also minimises additional strain on the healthcare system.

Pathology labs in high-income countries can provide results within hours. However, this is not the case in resource-constrained settings, including remote and rural Australia and low-income countries.

In these settings, a rapid point-of-care diagnostic test could form the basis of a liver health check tool, promoting awareness and management of liver disease.