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Abbott Laboratories’ ARCHITECT HIV Combo (Ag/Ab) Assay Demonstrates Earlier Disease Detection

Research presented at the American Association for Clinical Chemistry annual meeting shows that ARCHITECT HIV Combo (Ag/Ab) assay developed by Abbott for simultaneous detection of both HIV antigens and antibodies has reduced the detection window by zero to nine days in the study compared to HIV antibody-only assays. Earlier detection was shown on four of the five panels tested.

The ability to use a blood test to diagnose HIV sooner, in the acute phase of the disease where antibodies are not yet present, presents an exciting opportunity in the fight against HIV, said Gerald Schochetman, Ph.D., senior director, infectious diseases, research and development, Abbott Diagnostics. This data is very promising and we are excited about the clinical potential of this assay to help detect HIV earlier.

The Abbott ARCHITECT HIV Combo (Ag/Ab) assay is an automated immunoassay test that is designed to detect HIV p24 antigen and antibodies to HIV type 1 (HIV-1 Group M and Group O) and/or type 2 (HIV-2) in human plasma and serum. ARCHITECT HIV Combo (Ag/Ab) incorporates HIV p24 antigen detection that enables diagnosing of HIV infection before HIV antibodies are detectable. HIV p24 antigen is a viral protein of the HIV antigen.

In 2004 this assay was launched in Europe and is not yet available in the United States. Abbott expects to submit a pre-market approval application for the assay to FDA later this year.