HIV testing--the perspective from across the pond.

The first assay to screen blood donations for HIV was licensed in the USA in 1985. Since then there has been a dramatic increase in the types and numbers of assays available for HIV testing coupled with improvements in the sensitivity and specificity of these assays. However, with this increase in choice the algorithms for the initial diagnosis and confirmation of HIV infection have also increased in diversity and complexity and no uniform algorithm exists. Different regulatory regimes have meant that different assays and assay formats are available worldwide. In the UK we have been fortunate in having access to the so called 4th generation HIV antigen/antibody assays for 10 years. The first 4th generation assay in the US was licensed last year. The availability of this class of assays has led to the development of new algorithms for use in the US market and this paper describes how after many years of diversity the HIV algorithms between the UK and US are now converging.