Rapid Diagnostic Kit Incorporates Lateral Flow Immunochromatographic Technique

A rapid diagnostic kit is 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. An instrument reader was designed for use with the CD4 test in laboratories and physician clinics. The reader is used to ensure a standardized approach in test-kit result interpretation.

The new test kit will be able to guide treatment decisions at the point of care (POC) without extensive training or sophisticated equipment. The reader will provide a level of automation and improved precision that will enhance uptake of the technology in the developed world, as well as a being a valuable tool for training in the developing world.

The use of rapid POC 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 human immunodeficiency virus (HIV) and AIDS, especially in resource-poor countries.

The Burnet Institute (Melbourne, Australia) in collaboration with Rush University (Chicago, IL, USA) and Duke University (Durham, NC, USA) developed the new rapid diagnostic kit. Early clinical trials of the CD4 kit currently in progress are showing promising results and the cost of the kit is estimated to be less than US$1.80 when commercially available.

Burnet Institute's Associate Prof. 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 an improved quality of life. He added, "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,"

Prof. Anderson spoke on global diagnostics at the Bio2010 International Convention in Chicago, (IL, USA), which took place from May3-6, 2010.

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Burnet Institute
Rush University
Duke University