Claims for Patent: 5,164,299

Summary for Patent: 5,164,299

Title:	Use of a mixture of conjugated and unconjugated solid phase binding reagent to enhance the performance of assays
Abstract:	In a solid phase homogeneous or heterogeneous assay for detection or quantitation of an analyte in a biological fluid, use of a combination of unconjugated binding reagent and carrier-conjugated binding reagent immobilized on the solid phase provides enhanced assay performance.
Inventor(s):	Lambert; Stephen B. (Rising Sun, MD)
Assignee:	E. I. Du Pont de Nemours and Company (Wilmington, DE)
Application Number:	07/497,062
Patent Claims:	1. A solid phase heterogeneous or homogeneous immunoassay to detect or quantitate an analyte in a liquid sample which comprises: a) reacting binding reagent, immobilized on a solid phase, with sample; and b) determining the extent of binding which occurs in step (a); wherein the immobilized binding reagent is a mixture of carrier-conjugated and unconjugated binding reagent in which the ratio of carrier-conjugated binding reagent to unconjugated binding reagent is in the range from 1:19 to 19:1. 2. An immunoassay of claim 1 wherein the analyte and binding reagent are members of an immunochemical binding pair. 3. Immunoassay of claim 2 wherein the carrier is a protein selected from bovine serum albumin, human serum albumin, ovalbumin, gelatin and casein. 4. Immunoassay of claim 3 wherein said assay is a competition immunoassay and further wherein the immobilized mixture of carrier protein-conjugated binding reagent and unconjugated binding reagent is contacted with sample and with labeled analyte, then reagents are added to determine the extent of binding of the immobilized binding reagent to labeled analyte. 5. Competition immunoassay of claim 4 wherein the binding reagent is a mixture of conjugated and unconjugated rHBcAg, the analyte is anti-HBc antibody, and the labeled analyte is enzyme-labeled high affinity monoclonal anti-HBc antibody. 6. Sandwich immunoassay of claim 1 wherein the immobilized binding reagent is contacted with a liquid sample, then reagents are added to determine the extent of binding of the immobilized binding reagent to the analyte. 7. Agglutination assay of claim 1 wherein a binding reagent which selectively binds the analyte is immobilized on the surface of a high refractive index particle and the immobilized binding reagent is contacted with a liquid sample and with a reagent which selectively binds the analyte, then the extent of agglutination of the immobilized binding reagent is determined. 8. Inhibition of agglutination assay of claim 1 wherein a binding reagent which selectively binds a reagent which selectively binds the analyte is immobilized on the surface of a high refractive index particle and the immobilized binding reagent is contacted with a liquid sample and with the reagent which selectively binds the analyte, then the extent of agglutination of the immobilized binding reagent is determined. 9. Agglutination assay of claim 8 wherein the binding reagent is the same as the analyte or is an analog of the analyte. 10. An immunoassay according to claim 1 wherein the reacting binding reagent in step (a) is immobilized directly on the solid phase. 11. An immunoassay according to claim 1 wherein the binding reagent in step (a) is immobilized through an intermediate on the solid phase. 12. An immunoassay according to claims 10 or 11 wherein another reagent which selectively binds the analyte is additionally reacted with the binding reagent. 13. An immunoassay according to claims 10, 11 or 12 wherein a labeled analyte is additionally reacted with the binding reagent. 14. An immunoassay according to claim 1 wherein the immobilized binding reagent is a mixture of carrier-conjugated and unconjugated binding reagent in which the ratio of carrier-conjugated binding reagent to unconjugated binding reagent is in the range from 1:3 to 3:1. 15. An immunoassay according to claim 1 wherein the immobilized binding reagent is a mixture of carrier-conjugated and unconjugated binding reagent in which the ratio of carrier-conjugated binding reagent to unconjugated binding reagent is in the range from 2:3 to 3:2.

Details for Patent 5,164,299

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2040-01-28