Not-for-Profit Organization for Management of Maximized Public Sector Benefits

Not-for-Profit Organization
for Management of Maximized Public Sector Benefits in Health Care

- Creator of Innovative Approaches to Intellectual Property Management
of Health Products for Improved Public Sector Access -
- Partner in Public-Private-Partnerships with Pharmaceutical Manufacturers -
   

HIV 1/2 Dipstick™                      

HIV 1/2 DipstickTM

- Rapid, Visual, Low Cost Screening Test for HIV 1&2 for Use in Low Resources Settings -

The HIV 1/2 Dipstick™ is designed for manual rapid detection of HIV-1 and HIV-2 at lowest possible cost. Test results are read visually and testing can be performed in district hospital laboratories even in resource-limited environments. This simple-to-use test for HIV-1 and HIV-2 is based on a core technology that was developed by PATH (Program for Appropriate Technologies in Health), Seattle, as a platform for a series of manual dipstick tests for the diagnosis of sexually-transmitted diseases.

The HIV 1&2 Dipstick was developed to detect the presence of specific antibodies against HIV in serum. The dipstick comes in form of an 8-tooth, polystyrene comb, which is coated with a protein component of HIV.

Upon immersion in serum any antibodies against HIV present in the serum specimen will bind to the protein on the comb. After treatment with a signal reagent these antibodies will be visualized as red dots on the teeth of the comb.

The whole test procedure has a total turnaround time of less than 30 minutes to arrive at the final results. All materials (except distilled water) and utensils necessary to perform the tests are included in the test kits, and no extra disposable materials etc. are required to avoid increasing the overall cost of testing.

The kit's performance was evaluated by the World Health Organization (WHO) reference laboratory in Antwerp, Belgium, in 1995, and the test results were 100% sensitivity and 98.77% overall specificity (100% specificity for Asian, European, and South American samples). The dipstick tested was able to identify seroconverters less than one day later than a 3rd generation ELISA test used as the gold standard.

Besides the application for low-cost serum screening, the HIV 1/2 Dipstick™ is a very valuable tool to assess the risk of mother-child transfection from HIV-positive mothers to their infants in high endemic areas with resource limitations of clinical laboratory services.

The dipstick is licensed through Concept Foundation for manufacturing and sales in developing countries to several licensees in Argentina, India, Indonesia, and Thailand. These licensees hold the marketing rights for the HIV 1/2 Dipstick™ in more than 30 countries.

 

How to use HIV 1/2 DipstickTM
 • visual instructions [popup]
 • pdf [150Kb]
 

 


Antigen incubation of the dipstick combs is a tedious manual procedure. 7 microliter aliquots of synthetic peptide are pipetted onto each tooth of the comb. While technology exists in Western countries that could automate this procedure,


Incubation phase of HIV dipstick combs during production


Magenta dots for HIV-positive specimen
 



HIV Dipstick test kit manufactured by licensee in India