New CD4 test kit can improve quality of life for HIV and AIDS patients

The use of rapid point-of-care diagnostic tests for the measurement of CD4 T-cells, a marker of the immune system will be an important factor in improving the lives of people living with HIV and AIDS especially in developing and resource-poor countries.

Speaking on global diagnostics at the Bio2010 International Convention in Chicago, Burnet Institute's Associate Professor David Anderson said point-of-care tests that are cheap, easy to use and reliable, and able to be read visually in the field meant that patients would receive access to antiretroviral drugs faster and have a resulting improved quality of life.

Australia's Burnet Institute in collaboration with Rush University and Duke University have developed a rapid diagnostic kit based on the measurement of the total amount of cell-associated CD4 protein in whole blood samples such as a finger prick. The methodology uses a simple lateral flow immunochromatographic technique incorporated into a rapid test kit design similar to a home pregnancy test. Early clinical trials of the CD4 kit are currently in progress are already showing promising results and researchers are estimating the cost of the kit to be less than AU$2 when commercially available.

In a recent collaboration, Burnet Institute has also joined with Australian biomedical applications company Axxin Ltd to develop an instrument reader specifically designed for use with the CD4 test in laboratories and physician clinics which can be used to ensure a standardised approach in test kit result interpretation essential for device approval in the developed world.

Professor Anderson said the new test kit was a significant advancement and would be able to guide treatment decisions at the point-of-care without extensive training or sophisticated equipment, while the reader provided a level of automation and improved precision that would enhance uptake of the technology in the developed world, as well as a valuable tool for training in the developing world.

"This style of rapid point-of-care tests have become valuable tools in infectious disease diagnostics and are especially useful for diagnosis of diseases such as HIV, hepatitis B and syphilis as well as containing outbreaks of rapidly spreading diseases, for example hepatitis E," he said.

The development of the CD4 test kit has been supported in part by the Doris Duke Charitable Foundation, the CD4 Initiative (Imperial College, London), while development of the instrument reader has been supported by the Australian Centre for HIV and Hepatitis Virology.