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Performance evaluation of the Determine® HIV - 1/2 Ag/Ab Combo

Performance evaluation of the Determine[r] HIV - 1/2 Ag/Ab Combo, a novel 4th generation rapid test

Tomer Keren, Thierry Guidasci, Baruch Rivetz, Falk Fish
Inverness Medical Innovations Inc., Waltham, USA


Calling for a move towards universal access to HIV prevention, treatment, care and support, the WHO, UNAIDS and health organizations are encouraging the use of rapid HIV diagnostics as a tool to effectively address the epidemic. Widely used 3rd generation antibody assays do not detect acute/early infection. Fourth generation assays, able to shorten the “diagnostic window” by detecting both antibodies and p24 antigen, are setting the standard in HIV case identification. However, most 4th generation tests are in EIA format and do not differentiate the two markers. Also, EIA’s are intended for deployment in central labs and are not accessible in remote areas where the need is significant.

Inverness Medical has developed the Determine® HIV-1/2 Ag/Ab Combo, the first single rapid immunochromatographic test strip, which provides simultaneous and differentiated detection of HIV-1 p24 antigen and antibodies to HIV-1/2.

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