CA2673296A1 - Improved assay for immunosuppressant drugs - Google Patents

Improved assay for immunosuppressant drugs Download PDF

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Publication number
CA2673296A1
CA2673296A1 CA002673296A CA2673296A CA2673296A1 CA 2673296 A1 CA2673296 A1 CA 2673296A1 CA 002673296 A CA002673296 A CA 002673296A CA 2673296 A CA2673296 A CA 2673296A CA 2673296 A1 CA2673296 A1 CA 2673296A1
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CA
Canada
Prior art keywords
test kit
salt
immunosuppressant drug
glycol
alcohol
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002673296A
Other languages
French (fr)
Other versions
CA2673296C (en
Inventor
Susan M. Drengler
Bennett Wade Baugher
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Susan M. Drengler
Bennett Wade Baugher
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Laboratories, Susan M. Drengler, Bennett Wade Baugher filed Critical Abbott Laboratories
Publication of CA2673296A1 publication Critical patent/CA2673296A1/en
Application granted granted Critical
Publication of CA2673296C publication Critical patent/CA2673296C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • G01N33/9493—Immunosupressants

Abstract

The invention provides immunoassays for immunosuppressant drugs, wherein the assay is carried out under high salt conditions to achieve improved sensitivity. The invention also provides kits that are useful for performing the methods of the invention.

Claims (30)

1. A method for assessing the presence or concentration of an immunosuppressant drug in a test sample, the method comprising:
contacting a test sample or test sample extract with an antibody specific for an immunosuppressant drug under conditions suitable for binding of the antibody to the immunosuppressant drug, if present, to form an assay mixture, wherein said conditions comprise a salt concentration of greater than about 0.4 M; and detecting binding of the antibody to the immunosuppressant drug.
2. The method of claim 1, wherein the immunosuppressant drug is selected from the group consisting of tacrolimus, everolimus, zotarolimus, cyclosporine, and analogs of any of these compounds.
3. The method of claim 1, wherein the immunosuppressant drug comprises tacrolimus.
4. The method of claim 1, wherein the immunosuppressant drug comprises cyclosporine.
5. The method of claim 1, wherein the test sample comprises a human blood sample.
6. The method of claim 1, wherein the salt concentration is less than or equal to about 4.0 M.
7. The method of claim 1, wherein the salt concentration is about 2.0 M.
8. The method of claim 1, wherein the salt comprises a monovalent anion.
9. The method of claim 9, wherein the monovalent anion comprises chloride.
10. The method of claim 9, wherein the salt comprises a chloride salt of an alkali metal.
11. The method of claim 10, wherein the salt comprises sodium chloride.
12. The method of any of claims 1 to 12, wherein the assay mixture additionally comprises:
a glycol selected from the group consisting of ethylene glycol, propylene glycol, and an analog thereof; and at least one alcohol having five or fewer carbons.
13. The method of claim 12, wherein the alcohol is selected from the group consisting of methanol, ethanol, and propanol.
14. The method of claim 12, wherein the ratio of glycol to alcohol is in the range of about 4:1 to about 1:4.
15. The method of claim 14, wherein the ratio of glycol to alcohol is in the range of about 4:1 to about 1:2.
16. A test kit comprising:
(a) at least one antibody capable of binding specifically to at least one immunosuppressant drug;
(b) an assay diluent comprising a salt at a concentration of at least about 1.0 M; and (c) a lysis reagent comprising:
a glycol selected from the group consisting of ethylene glycol, propylene glycol, and an analog thereof; and at least one alcohol having five or fewer carbons.
17. The test kit of claim 16, wherein the immunosuppressant drug is selected from the group consisting of tacrolimus, everolimus, zotarolimus, cyclosporine, and analogs of any of these compounds.
18. The test kit of claim 16, wherein the immunosuppressant drug comprises tacrolimus.
19. The test kit of claim 16, wherein the immunosuppressant drug comprises cyclosporine.
20. The test kit of claim 16, wherein the salt concentration is less than or equal to about 10.0 M.
21. The test kit of claim 16, wherein the salt concentration is about 4.5 M.
22. The test kit of claim 16, wherein the salt comprises a monovalent anion.
23. The test kit of claim 22, wherein the monovalent anion comprises chloride.
24. The test kit of claim 23, wherein the salt comprises a chloride salt of an alkali metal.
25. The test kit of claim 24, wherein the salt comprises sodium chloride.
26. The test kit of any of claims 16 through 25, additionally comprising a control composition comprising the at least one immunosuppressant drug of (a).
27. The test kit of claim 26, wherein the alcohol is selected from the group consisting of methanol, ethanol, and propanol.
28. The test kit of claim 26, wherein the ratio of glycol to alcohol is in the range of about 4:1 to about 1:4.
29. The test kit of claim 26, wherein the ratio of glycol to alcohol is in the range of about 4:1 to about 1:2.
30. A test kit comprising:
(a) at least one antibody or protein capable of binding specifically to at least one immunosuppressant drug selected from the group consisting of tacrolimus and cyclosporine;
(b) an assay diluent comprising a salt at a concentration of at least about 1.0 M;
(c) a lysis reagent comprising:
(i) propylene glycol and ethanol at a ratio in the range of about 4:1 to about 1:2; and (d) a control composition comprising the at least one immunosuppressant drug of (a).
CA2673296A 2006-12-29 2007-12-19 Improved assay for immunosuppressant drugs Active CA2673296C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US88286306P 2006-12-29 2006-12-29
US60/882,863 2006-12-29
PCT/US2007/088098 WO2008082982A1 (en) 2006-12-29 2007-12-19 Improved assay for immunosuppressant drugs

Publications (2)

Publication Number Publication Date
CA2673296A1 true CA2673296A1 (en) 2008-07-10
CA2673296C CA2673296C (en) 2012-10-16

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CA2673296A Active CA2673296C (en) 2006-12-29 2007-12-19 Improved assay for immunosuppressant drugs

Country Status (6)

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US (2) US8129127B2 (en)
EP (1) EP2118656B1 (en)
JP (1) JP4968611B2 (en)
CA (1) CA2673296C (en)
ES (1) ES2393135T3 (en)
WO (1) WO2008082982A1 (en)

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Also Published As

Publication number Publication date
EP2118656A1 (en) 2009-11-18
CA2673296C (en) 2012-10-16
US20120156805A1 (en) 2012-06-21
WO2008082982A1 (en) 2008-07-10
US20090325197A1 (en) 2009-12-31
EP2118656A4 (en) 2011-03-09
JP2010515064A (en) 2010-05-06
EP2118656B1 (en) 2012-08-29
JP4968611B2 (en) 2012-07-04
US8129127B2 (en) 2012-03-06
ES2393135T3 (en) 2012-12-18
US8404452B2 (en) 2013-03-26

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