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A core capability of Burnet is the development of novel Rapid Point-of-Care (RPOC) diagnostic tests through the expertise of Associate Professor David Anderson and his team.
Associate Professor Anderson’s laboratory has developed a number of RPOC tests for use in the developing world including HIV, hepatitis E, hepatitis A and active syphilis.
Burnet has partnered with manufacturers to bring hepatitis E and HIV tests to the market. The team has applied this technology to other infectious diseases, and is undertaking a project to develop an accurate antibody test for COVID-19.
Diagnostics play a critical role in increasing access to quality treatment for those in the developing world, particularly for infectious diseases such as hepatitis and HIV.
Unfortunately, the majority of those individuals living in rural and remote areas of the developing world have limited access to testing.
This is mainly due to the issues of logistics, training and equipment associated with many of the tests that operate routinely in centralised laboratories.
Primary healthcare settings simply do not have the resources to carry out testing in this manner.
There is a clear need for the development of simple, low-cost and accurate tests that can be operated without associated infrastructure, in the field.
Developing diagnostics that can be operated in remote and rural areas of the developing world is essential to improving the health of poor and vulnerable communities globally.
Burnet’s team have particular expertise in the development of lateral flow tests that operates in a similar format to a pregnancy test.
Lateral flow test typically work by detecting the presence or absence of a target analyte in a sample. They are a form of immunoassay where the test sample flows along a solid substrate which has been impregnated by relevant reagents such antibodies or antigens.
After the sample is applied the sample encounters these reagents which cause it to change colour and become bound to the reagents on the test line. Results are typically read as either positive or negative and in some cases will be read in reference to a test line.
Associate Professor David Anderson is the Head of the Diagnostic Development Laboratory at Burnet Institute and has extensive commercial and product development experience.
A Deputy Director of Burnet, he is a co-inventor on 10 patent families, including the CD4 ELISA patent and is author on more than 20 peer-reviewed papers in the areas of diagnostics and vaccine development.
Experienced in deal negotiation, he has successfully licensed three Burnet developed diagnostic technologies to international diagnostic manufacturers.
Associate Professor David Anderson at the NHMRC Ten of the Best Publication launch. Photo courtesy of NHMRC/Marcus Fillinger - Emulsion.
Diagnostic Tests Developed at Burnet
VISITECT® CD4, developed by Burnet Deputy Director Associate Professor David Anderson, Burnet Associate Director Professor Suzanne Crowe AM, and their team, is an affordable point-of-care test for HIV-positive patients around the world.
Before HIV-infected patients are treated with anti-retroviral drugs their CD4 T cells must be below 350 cells per microlitre (according to current WHO treatment guidelines).
Most laboratories and clinics in countries most affected by HIV and AIDS are unable to monitor CD4 T cells, particularly in remote and rural settings.
Associate Professor Anderson and his team have developed a novel rapid point of care for the measurement of CD4 T cell levels in a similar format to a pregnancy test.
It does not require highly trained personnel to operate and can be performed in remote settings by health out-reach workers giving a simple treat or no treat result.
In 2019, the VISITECT® CD4 Advanced Disease test was approved for procurement by the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The Burnet team developed the first HEV IgM Rapid Assay to detect IgM antibodies to Hepatitis E virus (HEV) in human sera. It was designed as a diagnostic tool for the detection of anti-HEV IgM in patients presenting with symptoms of acute viral Hepatitis.
Burnet Institute first developed the assay in 1998 in association with AMRAD ICT. The test is now sold under license worldwide by MP Biomedical (Asia-Pacific).
Syphilis remains a worldwide public health problem with around 12 million new cases each year, 90 per cent of these in developing nations.
A wide range of diagnostic tests exist to diagnose both active and past syphilis infection, however many of these tests are of limited value in primary healthcare settings especially in developing countries.
RPOC tests for the detection of antibodies against Treponema pallidum have been widely available for a number of years, however there are no RPOC tests that can specifically detect IgM class antibodies to T. pallidum and none that can distinguish between infections that are active or those that have been treated in the past.
Previous RPOC tests have limited value in areas where syphilis is endemic or in some high-risk groups.
Burnet has developed a simple, rapid test that allows the detection of T. pallidum specific IgM, without the interference of specific IgG.
The Burnet Syphilis IgM rapid assay represents the first RPOC assay for the detection of T. pallidum specific IgM, and should be a valuable tool for the improved control of syphilis worldwide.
The Burnet diagnostic development team has worked with a number of different organisations to assist them in the development of unique and novel rapid point of care diagnostics. These relationships range from straight contract work to collaborative projects in areas where the Burnet has a focus interest.
Associate Professor Anderson and his team have collaborating with Axxin Ltd in Melbourne, Australia on the development of an inexpensive and robust instrument/reader for the CD4 test. This instrument provides greater accuracy and assists in training and quality control. The additional capabilities of the Axxin instrument will be important in the development of other much-needed point of care tests.