Additional research is needed to identify, characterize, and standardize indoor allergenic extracts used for diagnostic testing.

Research Agenda Item: Develop standardized, well-defined indoor-allergen reagents for skin tests that can be used in clinical diagnosis and research studies.

In Vitro Tests

The accuracy of any immunodiagnostic test is highly dependent on the characteristics of the test reagents, in particular, the allergen reagent. Standardization and characterization of allergen reagents used for immunodiagnostic tests are imperative. There are a variety of characterization methods and unitages that could be used. Similarly, the existence and characterization of control antibody, whether polyclonal or monoclonal, would be valuable for standardization and quality control of immunodiagnostic tests. Ideally, minimal standards for quality control should be devised for labs reporting results of tests to detect specific immunologic responses to indoor allergens.

Once the above are instituted, the specificity, sensitivity, and positive predictive value of immunodiagnostic tests could be determined for use in major epidemiological studies or to determine specific immunologic responses of individuals to indoor allergens. In addition, the degree of cross-reactivity of antibody developed in response to a given allergen could be determined by cross-inhibition with other allergens. It would be important to assess these factors prior to embarking on any large epidemiological studies. There are also several unclear aspects of the immunopathogenesis of allergic disease that need elucidation in order to define the role of various tests (e.g., tests of specific cell-mediated immunity in asthma). Further immunopathogenic studies of non-IgE-mediated asthma and cellular studies in all types of immunologic asthma will be required to clarify these issues.

Future studies in the development of in vitro diagnostic tests should include the following:

Research Agenda Item: Identify selected allergens of potential research usefulness, and prepare pure reference standards for the development of immunoassays, including those that can be used in large scale epidemiological studies.

Research Agenda Item: Develop and assess immunoassays for new allergens, including low molecular weight allergenic chemicals, that can be used for research and for the diagnosis of allergic disease.

Pulmonary Function

Bronchial hyperreactivity is a feature of asthma that correlates with clinical severity and does not require repeated measurement. It is unclear,



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