Analytical devices for detection of low-quality pharmaceuticals
First Claim
1. A multilayer paper analytical device for detection of at least two chemical components indicative of a low quality pharmaceutical product or dietary supplement, comprising:
- one or more assay regions in communication with a non-chemically interfering binder agent disposed adjacent at least one hydrophobic layer; and
one or more vessels each having a wall that houses one or more reagents in registry with at least one assay region for which testing for a chemical component is desired;
wherein the binding agent and hydrophobic layer provide a fluid path such that rupture of a vessel wall establishes fluid communication between the one or more reagents released by the ruptured vessel wall and a corresponding assay region along the fluid path;
wherein each assay region is configured to receive a sample of a suspected a low quality pharmaceutical product or dietary supplement such that, after activation of the device by rupturing of a vessel wall in registry with the assay region, the reagent wets the assaying region for reaction with the sample.
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Accused Products
Abstract
A multilayer Paper Analytical Device (PAD) is provided for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product. A method for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product is also provided that employs a multilayer PAD. A kit is provided for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product that includes a multilayer PAD and instructions for using the kit.
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Citations
20 Claims
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1. A multilayer paper analytical device for detection of at least two chemical components indicative of a low quality pharmaceutical product or dietary supplement, comprising:
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one or more assay regions in communication with a non-chemically interfering binder agent disposed adjacent at least one hydrophobic layer; and one or more vessels each having a wall that houses one or more reagents in registry with at least one assay region for which testing for a chemical component is desired; wherein the binding agent and hydrophobic layer provide a fluid path such that rupture of a vessel wall establishes fluid communication between the one or more reagents released by the ruptured vessel wall and a corresponding assay region along the fluid path; wherein each assay region is configured to receive a sample of a suspected a low quality pharmaceutical product or dietary supplement such that, after activation of the device by rupturing of a vessel wall in registry with the assay region, the reagent wets the assaying region for reaction with the sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A multilayer paper analytical device for detection of at least two chemical components indicative of a low quality pharmaceutical product or dietary supplement, comprising:
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one or more assay regions in communication with a non-chemically interfering binder agent disposed adjacent at least one hydrophobic layer; one or more vessels each having a wall that houses one or more reagents in registry with at least one assay region for which testing for a chemical component is desired; wherein the binding agent and hydrophobic layer provide a fluid path such that rupture of a vessel wall establishes fluid communication between the one or more reagents released by the ruptured vessel wall and a corresponding assay region along the fluid path; wherein each assay region is configured to receive a sample of a suspected a low quality pharmaceutical product or dietary supplement such that, after activation of the device by rupturing of a vessel wall in registry with the assay region, the reagent wets the assaying region for reaction with the sample; at least one optically readable information zone which after activation of the device provides color information necessary for detection of the at least two chemical components, wherein the at least one optically readable information zone comprises alignment references for transforming or correcting a captured image of the paper analytical device to facilitate analysis, wherein the alignment references include a plurality of fiducial markers for orienting the captured image; a color calibration zone that includes reference colors to assist in processing of the color information obtained from the assay regions after activation of the device to more accurately detect the at least two chemical components; and a two-dimensional barcode.
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Specification