Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1995-02-27
1998-02-03
Chan, Christina Y.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435353, 436513, 5303871, 5303873, C07K 1644, C12N 516, G01N 33566
Patent
active
057143382
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the field of diagnosis of allergic disease, and to the screening of therapeutics for the treatment of allergic disease.
2. Description of the Background and Related Art
Three major techniques have been used in the diagnosis of allergic disease: skin tests, assays of IgE serum levels, and histamine release tests. Skin tests have represented the primary diagnostic tool in allergy since their introduction in 1865. The classical skin test in atopy is the Type I wheal and flare reaction in which antigen introduced into the skin leads to the release of preformed mediators, increased vascular permeability, local edema and itching. Such skin tests can provide useful confirmatory evidence for a diagnosis of specific allergy that has been made on clinical grounds. However, when improperly performed, skin tests can lead to falsely positive or negative results. The main limitation of the skin test is that a positive reaction does not necessarily mean that the disease is allergic in nature, as some non-allergic individuals have specific IgE antibodies that produce a wheal and flare reaction to the skin test without any allergic symptoms.
The IgE-mediated false positive phenomenon observed in skin tests is not observed in in vitro methods for assaying allergen-specific IgE in patient serum (see Homburger and Katzmann, "Methods in Laboratory Immunology: Principles and Interpretation of Laboratory Tests for Allergy," in Allergy Principles and Practice, Middleton et al., eds, Mosby, pub., 4th Edition, vol. 1, chap. 21, pp. 554-572(1993)) Typically, allergen-specific IgE levels are measured by a radioallergosorbent test (RAST) wherein a patient's serum is incubated with antigen-coated sorbent particles, followed by detection of the specific. IgE bound to antigen with labelled antibody (see, e.g., Schellenberg et al., J. Imunol., 115: 1577-1583 (1975)).
Total serum IgE levels are also used in the diagnosis of allergy. Total IgE levels can be measured by radioimmunoassy or immunometric assay methods as described by Homburger and Katzmann, supra. IgE levels are often raised in allergic disease and grossly elevated in parasitic infestations. When assessing children or adults for the presence of atopic disease, a raised level of IgE aids the diagnosis although a normal total IgE level does not exclude atopy. The determination of total IgE alone will not predict an allergic state as there are genetic and environmental factors which play an important part in the production of clinical symptoms. The value of serum IgE level in allergy diagnosis is also limited by the wide range of IgE serum concentrations in healthy individuals. The frequency distribution of IgE concentrations in healthy adults is markedly skewed with wide 95 percentile limits and a disproportionate number of low IgE values. Accordingly, in calculating the 95 percentile limits of normal IgE levels most investigators treat their data by logarithmic transformation, which yields upper limits for normal serum IgE that are very high when compared with arithmetic means. These high upper limits for normal serum IgE diminish the diagnostic value of the serum IgE test in screening for clinical allergy.
Histamine release tests provide a means to detect functional, allergen-specific IgE in patient serum. Typically, histamine release tests imitate the allergen-specific reaction as it occurs in the patient (see, e.g., under van der Zee et al., J. Allergy Clin. Immunol., 82: 270-281 (1988)). This response has been generated in vitro by mixing a patient's blood with different allergens and later measuring the amount of histamine released during each of the subsequent allergic reactions. In vitro histamine release assays originally required the isolation of leukocytes from whole blood and/or various extractions of free histamine. Leukocyte histamine release tests were subsequently refined and automated to avoid cell isolation and histamine extraction (see, e.g., Siraganian et al., J. Allergy Clin. Imm
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Fei David Tai Wai
Jardieu Paula
Lowe John
Chan Christina Y.
Genentech Inc.
Love Richard B.
VanderVegt F. Pierre
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