Claims for Patent: 6,387,711

Summary for Patent: 6,387,711

Title:	Liquid intact parathyroid hormone (PTH) standards
Abstract:	A solution of a non-reconstituted hormone and a preservative having a useful shelf life of at least six months, and, in some circumstances, at least a year. A series of solution of varying levels of the non-reconstituted hormone may be in a test kit and used in a process to determine the level of the hormone in a patient sample. In an aspect of the invention, the hormone is parathyroid hormone. The preservatives may be polyvinyl alcohol, a dissolved EDTA salt, or dissolved sodium molybdate. The hormone may be in an aqueous or a buffered matrix containing very little protein and substantial amounts of TX100 to reduce non-specific binding. The solution is incubated with a solid phase coated with an anti-hormone antibody and a labeled hormone antibody. The solid phase is read using a suitable device for measuring the labeled hormone antibody. An example of a labeled hormone antibody is an acridinium labeled hormone antibody that is read using a light reading device.
Inventor(s):	Sundaram; Lata (Laguna Niguel, CA), Hoang; Ann (Lake Forest, CA), Shimizu; Stan (Trabuco Canyon, CA)
Assignee:	Quest Diagnostics Investments Incorporated (Wilmington, DE)
Application Number:	09/637,649
Patent Claims:	1. A solution comprising a non-reconstituted parathyroid hormone and a preservative, wherein the solution has a useful life of at least six months, the preservative comprises a polyvinyl alcohol, EDTA and molybdate. 2. The solution of claim 1, wherein the preservative further comprises non-specific binding reducer t-octylphenoxypolyethoxyethanol (TX-100) and human serum; the EDTA and molybdate being dissolved EDTA di-sodium salt and dissolved sodium molybdate, respectively. 3. The solution of claim 1, wherein the preservative, expressed as a percentage of the solution, comprises less than 1% polyvinyl alcohol, less than 0.5% dissolved EDTA di-sodium salt, less than 1% dissolved molybdate, and further comprises less than 1.5% t-octylphenoxypolyethoxyethanol (TX-100), and less than 5% human serum. 4. The solution of claim 1, wherein the preservative, expressed as a percentage of the solution, comprises approximately 0.5% polyvinyl alcohol, approximately 0.17% dissolved EDTA di-sodium salt, and approximately 0.7% dissolved molybdate. 5. The solution of claim 1, and further comprising approximately 0.5% t-octylphenoxypolyethoxyethanol (TX-100) and 2.0% human serum as a non-specific binding reducer. 6. A diagnostic test system comprising: a. a plurality of standards of known percentages of a non-reconstituted parathyroid hormone in a solution comprising a preservative, wherein the standards have a useful shelf life of at least six months, the preservative comprises a polyvinyl alcohol, EDTA and molybdate; b. a solid phase coated with anti-hormone antibody; and c. a solution of labeled antibody of the hormone. 7. The system of claim 6, wherein the preservative comprises polyvinyl alcohol, a dissolved EDTA salt, and dissolved sodium molybdate. 8. The system of claim 6, wherein the preservative, expressed as a percentage of the standards, comprises less than 1% polyvinyl alcohol, less than 0.5% dissolved EDTA di-sodium salt, and less than 1% dissolved sodium molybdate. 9. The system of claim 6, wherein the preservative, expressed as a percentage of the standards, comprises approximately 0.5% polyvinyl alcohol, approximately 0.17% dissolved EDTA di-sodium salt, and approximately 0.7% dissolved sodium molybdate.

Details for Patent 6,387,711

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