LOW COST, DISPOSABLE MOLECULAR DIAGNOSTIC DEVICES
First Claim
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1. A molecular diagnostic device for detecting a characteristic of a polynucleotide analyte present in a sample, the device comprising:
- at least first, second, and third substantially planar members for collection and amplification of a sample, one or more of which comprises fluid-impermeable barriers which define boundaries of hydrophilic regions therein which support fluid flow therethrough by sorption, wicking or wetting, another of which defines a test zone for collection, amplification, and visualization of a sample;
at least one of said members being adapted for lateral movement relative to another to permit establishment of fluid flow communication serially between at least two said hydrophilic regions and said test zone, and to permit interaction between the test zone and reagents disposed in fluid communication with the test zone at least at first and second separate stations;
said first station comprising a polynucleotide capture region wherein said test zone is disposed in fluid communication with a sample inlet;
said second station comprising a polynucleotide amplification region wherein said test zone and captured polynucleotides are in fluid communication with a buffer inlet and amplification reagents.
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Abstract
The invention provides molecular diagnostic test devices and methods for using such diagnostic test devices to detect analytes of biological significance in a patient. The diagnostic test devices are particularly useful for detecting a polynucleotide analyte in a sample obtained from a patient. Further, the diagnostic test devices are inexpensive, disposable, easy to use, and are useful at the point of care.
20 Citations
32 Claims
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1. A molecular diagnostic device for detecting a characteristic of a polynucleotide analyte present in a sample, the device comprising:
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at least first, second, and third substantially planar members for collection and amplification of a sample, one or more of which comprises fluid-impermeable barriers which define boundaries of hydrophilic regions therein which support fluid flow therethrough by sorption, wicking or wetting, another of which defines a test zone for collection, amplification, and visualization of a sample; at least one of said members being adapted for lateral movement relative to another to permit establishment of fluid flow communication serially between at least two said hydrophilic regions and said test zone, and to permit interaction between the test zone and reagents disposed in fluid communication with the test zone at least at first and second separate stations; said first station comprising a polynucleotide capture region wherein said test zone is disposed in fluid communication with a sample inlet; said second station comprising a polynucleotide amplification region wherein said test zone and captured polynucleotides are in fluid communication with a buffer inlet and amplification reagents. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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Specification