The development of monoclonal antibody-based immunochemical assays to measu
re antibodies, antigens and small molecules, such as drugs, ushered in a re
volution in modern diagnostic medicine. The impact of monoclonal antibodies
oil diagnostic imaging technologies and therapeutic regimes was equally dr
amatic. Additionally, the application of immunological techniques to the bi
ochemical research lab was partially responsible for the exponential growth
in our understanding of human physiology, biochemistry and genetics. Monoc
lonal antibody technology is limited, however, by the manner in which antig
en-antibody interactions can be controlled and by the ability to consistent
ly produce antibodies with appropriate affinity and specificity. Recent adv
ances in recombinant antigen preparation and antibody engineering have been
used to enhance the applications of this technology. In this review, curre
nt strategies to generate and engineer monoclonal antibodies as well as the
ir clinical applications are summarized. A brief review of molecular diagno
stics and its future trend is also included.