Claims for Patent: 7,459,276

Summary for Patent: 7,459,276

Title:	Methods and controls for monitoring assay quality and accuracy in parathyroid hormone measurement
Abstract:	The present invention relates to the use of control compositions and kits comprising such to evaluate and monitor the consistency of assays utilized to determine parathyroid hormone levels.
Inventor(s):	Cantor; Thomas L. (El Cajon, CA), Gao; Ping (San Diego, CA)
Assignee:	Scantibodies Laboratory, Inc. (Santee, CA)
Application Number:	10/674,294
Patent Claims:	1. A parathyroid hormone (PTH) assay control, comprising a composition having a known concentration of a whole PTH component mixed with a known concentration of a PTH fragment component, comprising: a) a whole PTH component having an amino acid sequence set forth in SEQ ID NO:1 (PTH.sub.1-84), wherein the N-terminal amino acid residue of the PTH molecule must be intact; and b) a PTH fragment component having an amino acid sequence set forth in SEQ ID NO:1 (PTH.sub.1-84), wherein the N-terminal amino acid residue of the PTH fragment starts at any position spanning position 2 through position 33 of the PTH.sub.1-84, the C-terminal amino acid residue of the PTH fragment ends at any position spanning position 35 through position 84 of the PTH.sub.1-84; and the PTH fragment has a minimal length of four amino acid residues; wherein the ratio of the whole PTH component to the PTH fragment component ranges between about 1% to about 99%, wherein said composition further comprises a protein matrix base, and wherein said assay control is lyophilized. 2. The PTH assay control of claim 1, wherein the composition comprises a total PTH component having the whole PTH component and the PTH fragment component combined in said protein matrix base at a predetermined ratio. 3. The PTH assay control of claim 1, wherein the whole PTH component and the PTH fragment component comprise chemically synthesized PTH peptides or recombinant protein. 4. The PTH assay control of claim 1, wherein the whole PTH component and the PTH fragment component are obtained from natural sources such as human serum, human plasma, or human parathyroid gland. 5. The PTH assay control of claim 4, wherein the whole PTH component and the PTH fragment component are purified prior to incorporation within the protein matrix. 6. The PTH assay control of claim 1, wherein the ratio of the whole PTH component to the PTH fragment component ranges between about 20% to about 80%. 7. A kit comprising one or more controls of claim 1 and instructions therefor. 8. The kit of claim 7, wherein the kit comprises two or more discrete controls, and each of the discrete controls comprises a composition having a different known concentration of the PTH components. 9. A kit comprising one or more controls of claim 2 and instructions therefor. 10. The kit of claim 9, wherein the kit comprises two or more discrete controls, and each of the discrete controls comprises a composition having a different ratio of PTH components. 11. The kit of claim 9, wherein each of the one or more controls comprises a composition having a different ratio of the whole PTH component versus the PTH fragment component. 12. The parathyroid hormone (PTH) assay control of claim 1, wherein the whole PTH component is PTH.sub.1-84 and the PTH fragment component is PTH.sub.7-84. 13. The parathyroid hormone (PTH) assay control of claim 1, wherein the whole PTH concentration ranges between about 0.7 pmol/L to about 3.9 pmol/l. 14. The parathyroid hormone (PTH) assay control of claim 1, wherein the PTH fragment component is selected from the group consisting of PTH.sub.2-84, PTH.sub.3-84, PTH.sub.4-84, PTH.sub.5-84, PTH.sub.6-84, PTH.sub.7-84, PTH.sub.8-84, PTH.sub.9-84, PTH.sub.10-84, PTH.sub.11-84, PTH.sub.12-84, PTH.sub.13-84, PTH.sub.14-84, PTH.sub.15-84, PTH.sub.16-84, PTH.sub.17-84, PTH.sub.18-84, PTH.sub.19-84, PTH.sub.20-84, PTH.sub.21-84, PTH.sub.22-84, PTH.sub.23-84, PTH.sub.24-84, PTH.sub.25-84, PTH.sub.26-84, PTH.sub.27-84, PTH.sub.28-84, PTH.sub.29-84, PTH.sub.30-84, PTH.sub.31-84, PTH.sub.32-84, and PTH.sub.33-84. 15. The parathyroid hormone (PTH) assay control of claim 1, wherein the PTH fragment component is selected from the group consisting of PTH.sub.7-69,PTH.sub.7-70, PTH.sub.7-71,PTH.sub.7-72, PTH.sub.7-73,PTH.sub.7-74,PTH.sub.7-75,PTH.sub.7-76,PTH.sub.7-77, PTH.sub.7-78,PTH.sub.7-79,PTH.sub.7-80,PTH.sub.7-81,PTH.sub.7-82,PTH.sub.- 7-83, and PTH.sub.7-84.

Details for Patent 7,459,276

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-03-29