Methods and kits for assays of analytes of interest in tears

• US 7,244,394 B2
• Filed: 09/03/2003
• Issued: 07/17/2007
• Est. Priority Date: 10/03/2002
• Status: Expired due to Fees

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Lane, Jennifer Dawn, Carney, Fiona Patricia, Morris, Carol Ann
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Ramillano; Lore
• Application Number:
  US10/654,196
• Publication Number:
  US 20040076547A1
• Time in Patent Office: 1,413 Days
• Field of Search: 422 56- 58, 521/141, 604/294
• US Class Current: 422/420
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0067 Tear or lachrymal fluid

Abstract

The invention, in one aspect, provides a strip for tear collection. The strip has a first end and an opposite second end and preferably has substantially uniform cross-sections from the first end to the second end. The strip is made of a hydrogel material in substantially dry state. The strip is characterized by having a substantially uniform swelling along the hydrogel strip from the first end to the second end when fully wicked by a tear fluid and by having a correlation between the volume of tear uptake by said strip and the length of the wicked end portion of said strip. A strip of the invention is useful for assay of an analyte of interest in a tear fluid. The invention also provides a method and kits for assaying an analyte of interest (e.g., lactoferrin, glucose, herpes simplex virus, hormones, etc.).

Claims

1. A kit for assaying an analyte of interest in a tear fluid of an eye, comprising:

a strip for collecting the tear fluid, wherein said strip has a first end and an opposite second end, wherein said strip is made of a hydrogel material in substantially dry state and is characterized by having a substantially uniform swelling along the hydrogel strip from the first end to the second end when fully wicked by a tear fluid and by having a correlation between the volume of tear uptake by said strip and the length of a tear-wicked end portion of said strip, wherein said hydrogel material is obtained by polymerization or copolymerization of at least one hydrophilic monomer in the presence of or in the absence of additional monomers and/or macromers and is selected from the group consisting of poly(vinyl alcohol), modified polyvinylalcohol, poly(hydroxyethyl methacrylate), poly(vinyl pyrrolidone), poly(vinyl alcohol) with polycarboxylic acids, polyacrylamide, polymethacrylamide, silicone-containing hydrogels, polyurethane, polyurea, and mixtures thereof; and

a testing agent composition which specifically reacts with the analyte of interest to form a detectable signal.

2. A kit of claim 1, wherein the cross-section of said strip is circular, and wherein the diameter of the circular cross-section is from 1 mm to 3 mm.

3. A kit of claim 1, wherein the cross-section of said strip is rectangular and has a width of from about 1 mm to about 3 mm and a height of from 0.5 mm to 1.5 mm.

4. A kit of claim 1, wherein said defined correlation between the volume of tear uptake by said strip and the length of the tear-wicked end portion of said strip is a substantially linear relationship.

5. A kit of claim 1, wherein said strip has noticeable marks thereon, wherein each of the marks indicates a volume of the tear fluid absorbed by the end portion up to that mark of said strip.

6. A kit of claim 1, wherein said analyte of interest is selected from the group consisting of:

an electrolyte, a metallic element, a polypeptide hormone, a chronically administered medication, an acutely administered medication, a small molecule hormone, a marker of inflammation, a marker of allergy, a lipid, a protein, a marker of infection, and a metabolite.

7. A kit of claim 6, wherein said analyte of interest is lactoferrin.

8. A kit of claim 6, wherein said analyte of interest is glucose.

9. A kit of claim 1, wherein said testing agent composition comprises a receptor that is capable of binding reversibly said analyte of interest and has a detectable optical signal that changes in a concentration-dependent manner when the receptor is bound to said analyte, wherein said detectable optical signal results from one or more labels associated with the receptor.

10. A kit of claim 9, wherein said detectable optical change is selected from the group consisting of changes in fluorescent decay time, fluorescent intensity, fluorescent anisotropy, fluorescence polarization, a spectral shift of the emission spectrum, and a change in time-resolved anisotropy decay.

11. A kit of claim 9, wherein the testing agent composition comprises:

(1) a fiuorescent energy donor and a fluorescent energy acceptor;

or (2) a fluorescent energy donor and a non-fluorescent energy acceptor.

12. A kit of claim 9, wherein the testing agent composition is one or more solutions or is incorporated partially or fully in said strip.

13. A kit of claim 1, wherein the testing agent composition comprises a receptor having a first label associated therewith, a competitor having a second label associated therewith, wherein one of the first and second labels is a fluorescent energy donnor and the other one is a fluorescent or non-fluorescent energy acceptor said testing agent composition comprises a receptor and a competitor, wherein said receptor comprises a analyte/competitor binding site to which the analyte can be reversibly bound.

14. A kit of claim 13, wherein the testing agent composition is one or more solutions or is incorporated partially or fully in said strip.