Office-Based Test Systems for HIV Antibody

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Abstract
The Food and Drug Administration has approved two assays for human immunodeficiency virus (HIV) antibody for use by “properly trained personnel” in physicians' offices, clinics, emergency rooms, and other settings “where enzyme immunoassays are not practical or available.” The indirect immunofluorescence and microfiltration enzyme immunoassays are available for purchase and use in a wide variety of contexts, yet their use raises serious concern about clinical or operational feasibility and about their effect on disease-surveillance programs and preventive intervention.

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