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The clinical immunology laboratory of the future
1Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21224.
Insights
Future clinical immunology laboratories will expand testing scope and analyte numbers, driven by automation and standardization. These advancements aim to improve diagnostic accuracy and patient management for immune system disorders.
Area of Science:
- Clinical Immunology
- Laboratory Medicine
Background:
- Clinical immunology laboratories are crucial for diagnosing and managing immune system dysfunctions.
- Current laboratory practices encompass scope of work, analytes, methods, specimens, instrumentation, and standardization.
Purpose of the Study:
- To define the current status of clinical immunology laboratories.
- To identify future trends in clinical immunology laboratory activities.
Main Methods:
- Analysis of six key aspects: scope of work, analyte groups, assay methods, specimen types, instrumentation, and standardization.
- Examination of diagnostic allergy laboratory as a model.
Main Results:
- Expected expansion in testing scope and analyte numbers.
- Trend towards laboratory consolidation and increased automation.
- Advancements in assay sensitivity, specificity, and simplification.
- Development of universal automated immunoanalyzers.
- Emphasis on standardization for interlaboratory agreement.
Conclusions:
- Clinical immunology laboratories are evolving towards broader capabilities and greater efficiency.
- Automation and standardization are key drivers for future laboratory practice.
- These changes will enhance the diagnosis and management of immune system disorders.
Abstract:
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.
