Patent: 6,599,691

Summary for Patent: 6,599,691

Title:	Rapid immunoassay to detect infection with Mycobacterium tuberculosis
Abstract:	A rapid, non-invasive, semi-quantitative immunoassay of saliva has been developed to aid in the diagnosis of diseases, e.g., using saliva to detect subjects actively or previously infected with Mycobacterium tuberculosis, a causative organism of tuberculosis. The semi-quantitative assay comprises spotting disease-related antigens on the surface of a solid substrate; contacting the solid substrate with a saliva sample which, in positive subjects, contains primary antibodies to the disease-related antigens; contacting the primary antibodies with a label capable of being detected; and detecting and reading the label whereby exposure to the antigens is determined. The device for conducting these assays is a frame or support which holds a solid substrate capable of immobilizing the antigens of interest while permitting drainage of other materials or fluids away from the immobilized antigens. A less rapid, quantitative assay has also been developed by adapting the rapid, semi-quantitative assay to an enzyme linked immunosorbant assay thereby providing a quantitative assay capable of assessing multiple saliva samples simultaneously.
Inventor(s):	Ralls; Stephen Alden (McLean, VA), Simonson; Lloyd Grant (Spring Grove, IL)
Assignee:	The United States of America as represented by the Secretary of the Navy (Washington, DC)
Application Number:	09/044,214
Patent Claims:	see list of patent claims

Details for Patent 6,599,691

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Par Pharmaceutical Companies, Inc.	APLISOL	tuberculin, purified protein derivative	Injection	103782	04/20/1998		2015-11-27
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941	02/24/2000		2015-11-27