Disintegratable films for diagnostic devices
First Claim
1. A disintegratable film for a diagnostic device capable of detecting the presence of an analyte of interest in an aqueous fluid sample, comprising:
- a first water soluble polymer having a molecular weight less than about 49,000 daltons;
a second water soluble polymer having a molecular weight greater than about 60,000 daltons; and
at least one reagent capable of permitting detection of an analyte of interest in an aqueous fluid sample,wherein the film is in the form of a monolayer of a thickness sufficient to disintegrate upon contact with the aqueous fluid applied to the diagnostic device to release the reagent.
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Abstract
The invention provides disintegratable film compositions for diagnostic test devices. The films are prepared with a combination of components that yield films of sufficient film strength and desired disintegration profiles. A disintegratable film according to the present invention contains a water soluble high molecular weight component, a water soluble low molecular weight component, and one or more reagents for use in a diagnostic device. Optionally, the films further contain a starch component, a glucose component, a plasticizer and/or a humectant, and/or a filler. The invention further provides a diagnostic testing device, which includes a film according to an embodiment of the invention, and methods of using such devices.
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Citations
37 Claims
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1. A disintegratable film for a diagnostic device capable of detecting the presence of an analyte of interest in an aqueous fluid sample, comprising:
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a first water soluble polymer having a molecular weight less than about 49,000 daltons; a second water soluble polymer having a molecular weight greater than about 60,000 daltons; and at least one reagent capable of permitting detection of an analyte of interest in an aqueous fluid sample, wherein the film is in the form of a monolayer of a thickness sufficient to disintegrate upon contact with the aqueous fluid applied to the diagnostic device to release the reagent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A disintegratable film for a diagnostic device capable of detecting the presence of an analyte of interest in an aqueous fluid sample, comprising:
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a first water soluble polymer having a molecular weight of about 30,000 daltons or less; a second water soluble polymer having a molecular weight of about 90,000 daltons or greater; and at least one reagent capable of permitting detection of an analyte of interest in an aqueous fluid sample, wherein the film is in the form of a monolayer of a thickness sufficient to disintegrate upon contact with the aqueous fluid applied to the diagnostic device to release the reagent. - View Dependent Claims (24, 25, 26, 27, 28)
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29. A testing device comprising:
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a support structure; and at least one disintegratable film supported by the support structure, the disintegratable film comprising; a first water soluble polymer having a molecular weight less than about 49,000 daltons; a second water soluble polymer having a molecular weight greater than about 60,000 daltons; and at least one reagent capable of permitting detection of an analyte of interest in an aqueous fluid sample, wherein the film is in the form of a monolayer of a thickness sufficient to disintegrate upon contact with the aqueous fluid applied to the diagnostic device to release the reagent. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37)
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Specification