Immunoassays for the diagnosis of HIV: meeting future needs by enhancing the quality of testing.

Immunoassays for detecting HIV infection perform better than other serological assays. HIV immunoassays are presented in a number of different formats: instrument-based, plate, rapid assays and as immunoblots. HIV immunoassays for screening and diagnosis are now in their fourth generation; an assay generation meaning that significant modifications to the assay format have led to a significant enhancement in quality. Although still not perfect, they are now of exceptionally high quality if conducted properly. Most problems relate to how the assays are performed. Many laboratories, especially in high human development index (HDI) countries, manage testing within functioning quality-management systems, but this is not true of laboratories in low HDI countries or in many medium HDI countries. Simple rapid tests for HIV are being used increasingly, and create special challenges for assuring quality. Users of HIV immunoassays are learning that a poorer assay used well has better outcomes than a splendid assay performed poorly. Experience highlights the importance of conducting HIV testing within quality-managed systems and according to international standards, but testing quality and laboratory quality management must be funded adequately.