The clinical immunology laboratory of the future.

The clinical immunology laboratory assumes the responsibility of providing a complete array of analytical measurements for the diagnosis and management of patients with dysfunction of the humoral (antibody, complement) and cellular (T/B cells, phagocyte) immune system. To identify trends in the activities of the clinical immunology laboratory of the future, I first define the current status of the clinical/diagnostic immunology laboratory, examining six aspects: scope of work, analyte groups, assay methods, specimen types, instrumentation, and standardization. The scope of the clinical immunology laboratory's testing is expected to expand, with a trend toward consolidation of work into fewer, more well-equipped laboratories. An increase is expected in the total number of analytes examined as well as in the numbers of analyte groups and specificities. Assay methods will continue to improve in analytical and clinical sensitivity and specificity, with an emphasis toward less-complex procedures. The primary specimens evaluated will still be serum, urine, tissue, and cells, with a minor expansion into the use of other, less-accessible human body fluids. Instrumentation will move toward increased automation, with the concurrent development of "universal" automated immunoanalyzers for use in humoral and cellular immunology. Finally, standardization of immunological measurements with calibrated reference proteins and antibodies will promote interlaboratory agreement. I describe the diagnostic allergy laboratory to illustrate the immunology laboratory environment.