Boehringer Mannheim modular test concepts in HIV and hepatitis immunoassays

Anti-HIV-antibody and hepatitis C virus (HCV)-antibody screening tests have to be able to detect a variety of virus antibodies. On the other hand, HIV-antigen specific antibody tests that detect only one kind of antibody are needed for prognosis of disease or for distinguishing infection by different virus subtypes. Usually in an enzyme-linked immunosorbent assay for each individual test an individual solid phase has to be created. For our Boehringer Mannheim Enzymun-Test Diagnostics Assay we used a single universal biotin-binding solid phase in all tests and biotin-labeled specific antigens for the individual tests. The modular system for the antibody tests is a convenient tool for the development of a broad test menu for different viruses. We show that the modular system is suited for screening tests for HIV1, HIV2, or HCV antibodies, as as well as for virus typing or for detection of HIV/p24-specific antibodies in a quantitative assay with high precision.