Description of Invention:
Available for licensing as a biological material or by material transfer is a microarray with immobilized antibodies specific to particular allergens or allergen epitopes and specifically allergens from an allergen vaccine or extract. Allergen extracts are manufactured and sold worldwide for the diagnosis and treatment of IgE-mediated allergic disease. Each extract contains a variety of active allergenic components (e.g., proteins, carbohydrates and other small molecules) in varying concentrations and immugenicities. Most allergen extracts are non-standardized. These extracts have been labeled either with a designation of extraction ratio (w/v) or with a protein unit designation determined using the Kjeldahl method (protein nitrogen units/mL). There appears to be little correlation between these two designations and biological measures of allergen potency. At present, there are nineteen standardized allergen extracts available from U.S. manufacturers. Each extract is assigned a potency value for sale to the public. Potency value is an arbitrary measurement based on quantitation of the total protein content and specific allergen content within the allergen extracts (as measured with hyperimmune sheep sera), or by the inhibition of the binding of IgE from pooled allergic sera to reference allergen. These methods are generally crude and provide only integral averages. These averages are non-characteristics of the concentration of individual allergens in the extract and their respective immunoglobulin binding affinities. By contrast, this microarray uses large numbers of engineered antibodies to “fingerprint” the test extract. The present invention provides 10-100 allergen specific scFV or Fab immunoglobulins imprinted on a solid matrix in multiple concentrations. The allergen mixture is applied to the array and the pattern of protein binding to each spot is analyzed quantitatively and qualitatively. Thus, large numbers of component allergenic proteins can be assayed quickly and simultaneously.
Inventors:
Jay E. Slater (FDA) William J. Finlay (FDA) Nicolette DeVore (FDA)
Patent Status:
DHHS Reference No. E-044-2004/0 -- Research Tool
Portfolios: Miscellaneous Devices/Instrumentation
Devices/Instrumentation-Diagnostics-Methods Devices/Instrumentation-Diagnostics-Other Devices/Instrumentation-Research Materials-Methods of Using Research Tools Devices/Instrumentation-Diagnostics Devices/Instrumentation-Research Materials
For Additional Information Please Contact: Michael Shmilovich J.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301) 435-5019
Email: shmilovm@mail.nih.gov
Fax: (301) 402-0220
