Claims for Patent: 8,039,272

Summary for Patent: 8,039,272

Title:	Rapid quantification assay involving concentrated and ligand-coated gold colloid
Abstract:	A concentrated and ligand-coated gold colloid and a method of preparing it. Also disclosed is a rapid biomolecule quantification assay involving the use of the concentrated gold colloid and an apparatus for performing the assay.
Inventor(s):	Sigillo; Eric C. (Marlborough, MA), Chien; Jeffrey C. (Wellesley, MA), Pomeroy; Mary C. (Framingham, MA), Saltalamacchia; Catherine A. (Winchester, MA)
Assignee:	Nova Biomedical (Waltham, MA)
Application Number:	12/416,570
Patent Claims:	1. A colloidal composition, comprising a plurality of gold particles coated with a protein ligand, wherein the composition has a gold particle concentration of (0.7-9.0).times.10.sup.12 particles/ml and a ligand concentration of 0.002-1.3 nmol/ml. 2. The colloidal composition of claim 1, wherein the gold particle concentration is (3.5-5.25).times.10.sup.12 particles/ml. 3. The colloidal composition of claim 1, wherein the ligand concentration is 0.002-0.82 nmol/ml. 4. The colloidal composition of claim 3, wherein the ligand concentration is 0.002-0.23 nmol/ml. 5. The colloidal composition of claim 1, wherein the protein ligand is selected from the group consisting of Protein A, Protein G, Protein A/G, Protein L, an antibody, a cell surface receptor, and a lectin. 6. The colloidal composition of claim 3, wherein the protein ligand is Protein A, Protein G, Protein A/G, Protein L, or an antibody specifically binding to an immunoglobulin. 7. The colloidal composition of claim 1, further comprising a surfactant. 8. The colloidal composition of claim 1, wherein the gold particles have an average diameter of 20-40 nm. 9. The colloidal composition of claim 8, wherein the gold particle concentration is (3.5-5.25).times.10.sup.12 particles/ml. 10. The colloidal composition of claim 8, wherein the ligand concentration is 0.002-0.23 nmol/ml. 11. The colloidal composition of claim 8, wherein the protein ligand is selected from the group consisting of Protein A, Protein G, Protein A/G, Protein L, an antibody, a cell surface receptor, and a lectin. 12. The colloidal composition of claim 11, wherein the protein ligand is Protein A, Protein G, Protein A/G, Protein L, or an antibody specifically binding to an immunoglobulin. 13. The colloidal composition of claim 8, further comprising a surfactant. 14. A method of preparing a coated gold colloid, comprising providing a gold colloid containing gold particles at a concentration of (0.7-9.0).times.10.sup.12 particles/ml, contacting the gold particles with a protein ligand at a pH value equivalent to the isoelectric point of the protein ligand to produce a coated gold colloid, wherein the ratio between the gold particles and the ligand is (0.7-9.0).times.10.sup.12 particles: 0.002-1.3 nmol, and collecting the coated gold colloid. 15. The method of claim 14, wherein the collecting step is performed by harvesting the coated gold colloid without removing unbound molecules of the protein ligand. 16. The method of claim 15, wherein the gold particles have an average diameter of 20-40 nm. 17. The method of claim 16, wherein the protein ligand is premixed with a surfactant. 18. The method of claim 16, further comprising mixing the coated golloid with a stabilizer to stabilize coating of the ligand on the gold particles. 19. The method of claim 16, wherein the protein ligand is selected from the group consisting of Protein A, Protein G, Protein A/G, Protein L, an antibody, a cell surface receptor, and a lectin. 20. The method of claim 16, wherein the protein ligand is Protein A, its concentration is 0.002-0.23 nmol/ml, and the pH value is 6.2. 21. A coated gold colloid prepared by the method of claim 15. 22. A method for quantifying a biomolecule, comprising: providing a colloidal gold composition of claim 1, mixing the colloidal gold composition with a sample suspected of containing the biomolecule to form a mixture, measuring the optical density of the mixture at a wavelength ranging from 540-700 nm, and determining the concentration of the biomolecule based on the value of the optical density. 23. The method of claim 22, wherein the optical density is measured at 590 nm. 24. The method of claim 22, wherein the gold particles have an average diameter of 20-40 nm. 25. The method of claim 24, wherein the colloidal gold composition further contains a surfactant. 26. The method of claim 24, wherein the biomolecule is an immunoglobulin and the protein ligand is Protein A, Protein G, Protein A/G, Protein L, or an antibody specifically binding to the immunoglobulin. 27. The method of claim 26, wherein the immunoglobulin is a human, humanized, chimeric, mouse, rat, rabbit, sheep, monkey, donkey, or goat immunoglobulin. 28. The method of claim 27, wherein the immunoglobulin is immunoglobulin G. 29. The method of claim 22, wherein the biomolecule is a glycoprotein and the protein ligand is a lectin. 30. The method of claim 22, wherein the protein ligand is an antibody that specifically binds to the biomolecule.

Details for Patent 8,039,272

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	12/12/2018		2040-01-28