Methods and kits for assays of analytes of interest in tears

Inactive Publication Date: 2007-06-21
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] One object of the invention is to provide a new tear

Problems solved by technology

Such imbalance may involve aqueous tear fluid, conjunctival mucin, and/or tear fluid lipid.
KCS frequently threatens ocular anatomic integrity, often causing conjunctival and corneal erosion.
While it is accurate in moderate to severe dry eye states, this method

Method used

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  • Methods and kits for assays of analytes of interest in tears
  • Methods and kits for assays of analytes of interest in tears
  • Methods and kits for assays of analytes of interest in tears

Examples

Experimental program
Comparison scheme
Effect test

Example

EXAMPLE 1

[0070] Poly(vinyl alcohol) (PVA) material is supplied by Ultracell. Wicks (strips) are prepared to have a dimension of 1.5 mm in width, 1.0 mm in depth and 30 mm in length as shown in FIG. 1. One of the two ends of a wick is dipped in a known volume of sample, such as tear, serum or phosphate buffer (PBS) (ca. pH 7.2). When a sample is absorbed (wicked) by the wick, the uptake on the wick is clearly visible. The length of the wicked portion of the wick for a given volume of sample is measured. This experiment is repeated 20 times. Reproducible linear curves are obtained, as shown in FIG. 3. The linear relationship between the length of the wicked portion of a PVA wick and the volume of uptake on the PVA wick is L (μl)=0.6205·Vol+0.7928 and L (μl)=0.6036·Vol+0.6699 respectively for tear and serum. The R2 values for tears and serum both are 0.99. The reproducibility of volume uptake is not as easily observed in three other design iterations including three cylindrical PVA wi...

Example

EXAMPLE 2

[0072] PVA wicks are prepared as described in Example 1. Three glucose solutions are prepared by dissolving glucose respectively in three media, PBS, tear and serum. The concentration of glucose is 150 mg per 100 ml. A wick is dipped in 5 μl of a glucose solution. After all of the solution is absored (wicked) by the wick, the wicked portion of the wick is cut in half. Each half (shown in FIG. 2) is then assayed for glucose using the commercially available Trinder assay from Sigma.

[0073] Results are shown in FIG. 4. Glucose in each of the three solutions is taken up by wicks. However, there is difference in the glucose uptake between the bottom half (i.e., containing the dipping end of the wick) and the top half. Such difference depends on the presence of other chemicals, for example, such as proteins, in a medium for preparing a glucose solution under study. The biggest difference is observed in the case where serum is used in preparation of glucose solution. However, it ...

Example

EXAMPLE 3

[0074] Tear samples have been collected from subjects using PVA wicks and glass capillary tubes in order to be assayed for total protein. It has been discovered that tear collection is much easier and faster using wicks. More tear fluid can be collected by means of PVA wicks in a shorter period of time compared to glass capillary tubes.

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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.).

Description

[0001] This application claims the benefit under USC §119 (e) of U.S. provisional application No. 60 / 415,914 filed Oct. 3, 2002, incorporated by reference in its entirety. [0002] The invention is related to a tear-collecting device, methods and kits for assays of analytes of interest in tears.BACKGROUND OF THE INVENTION [0003] Keratoconjunctivitis sicca (KCS) or “dry eye” is an ophthalmic condition defined by an insufficiency or imbalance of one or more of the ocular fluid components of an eye. Such imbalance may involve aqueous tear fluid, conjunctival mucin, and / or tear fluid lipid. KCS frequently threatens ocular anatomic integrity, often causing conjunctival and corneal erosion. “Dry eye” is a finding in about 25% of Sjogren's syndrome, which most often occurs in women past the age of 45 years. Sjogren's syndrome often detrimentally affects the immune system of the body; thus early detection and treatment is important. It has been estimated that several million persons in the Un...

Claims

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Application Information

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IPC IPC(8): B01L3/00A61B10/00
CPCA61B10/0045A61B2010/0067
Inventor CARNEY, FLONA PATRICIALANE, JENNIFER DAWNMORRIS, CAROL ANN
Owner NOVARTIS AG
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