Methods for the genetic engineering production of antigens and their use in an approach to confirmatory tests for antibodies in the example of human immunodeficiency virus (HIV)

This invention entails the detection of HIV 1 antibodies in human serum samples or CSF in a reliable and more sensitive manner than has been possible with Western blots using virus preparations as antigen. This invention also describes the generation of recombinant DNA molecules which carry HIV 1-encoding protein segments and which ensure stable expression of these protein segments in E.coli. This stable expression in E.coli takes place without heterologous fusion proteins in order to be able to rule out non-specificities against E.coli constituents in a test. Furthermore, this invention permits, by use of the recombinant antigens in a particular test approach, a more sensitive detection of HIV 1 antibodies and, at the same time, a reliable differentiation from non-specific reactions. Finally, the approach described in the invention is orders of magnitude more favourable in cost terms than the previously used HIV 1 confirmatory test (Western blots with viral purified antigens).