Scientists develop rapid point-of-care diagnostic test to measure CD4 T-cells

Scientists at Australia's Burnet Institute have developed a rapid point-of-care diagnostic test for the measurement of CD4 T-cells, a marker of the immune system for people living with HIV and AIDS.

Based on the measurement of cell-associated CD4 protein in whole blood samples such as a finger prick, the kit will enable patients to receive appropriate treatment earlier without having to wait for reference laboratory test results which requires a repeat visit. 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 currently in progress are showing promising results with researchers estimating the cost of the kit to be less than AU$2 when commercially available.

In a recent collaboration, Burnet Institute has 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.

Speaking at the University of California, Irvine conference Future Diagnostics, Burnet Institute's Associate Professor David Anderson said the point-of-care test was easy to use and reliable, and while it could simply be read visually in the field, the provision of the new reader would ensure that interpretation of the results was not subject to operator variation, and would provide a valuable resource for training in proper use and interpretation of the CD4 test.

"The new test kit and reader are significant advancements and will be able to guide treatment decisions at the point-of-care without extensive training or sophisticated equipment and should lead to improved access to antiretroviral drugs, especially in developing and resource-constrained countries," Professor Anderson 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.

SOURCE Burnet Institute