Self-venting immunodiagnositic devices and methods of performing assays
First Claim
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1. A method for detecting the presence or an amount of an analyte in a test sample, comprising providing:
- (a) an analytical device comprising;
a housing made of a hydrophobic material, said hydrophobic material consisting of;
acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;
said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing and having at least one reagent therein;
said track having at least one hydrophobic surface modified to create a hydrophilic surface by introducing at least one hydrophilic group onto said hydrophobic surface, said hydrophilic group consisting of;
hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates;
said hydrophobic material being impermeable to said test sample and allowing gaseous exchange in and out of a portion of said track;
(b) adding said test sample to said housing through said inlet port;
said test sample and said reagent producing a detectable signal upon mixing; and
(c) determining the presence or an amount of an analyte in said test sample from said detectable signal.
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Abstract
Methods and devices are provided involving an inlet port, at least one chamber, a channel providing access for fluids to flow through via capillary action or differential pressure, reagents, detection means and self-venting materials. The devices allow for the appropriate mixing, reacting, incubating needed to give a detectable signal which can be read. The self-venting materials allow for the 1) displacement of gases inside a track to the outside of the device and 2) oxygen movement into the track from the outside.
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Citations
44 Claims
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1. A method for detecting the presence or an amount of an analyte in a test sample, comprising providing:
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(a) an analytical device comprising;
a housing made of a hydrophobic material, said hydrophobic material consisting of;
acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing and having at least one reagent therein; said track having at least one hydrophobic surface modified to create a hydrophilic surface by introducing at least one hydrophilic group onto said hydrophobic surface, said hydrophilic group consisting of;
hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates;said hydrophobic material being impermeable to said test sample and allowing gaseous exchange in and out of a portion of said track; (b) adding said test sample to said housing through said inlet port; said test sample and said reagent producing a detectable signal upon mixing; and (c) determining the presence or an amount of an analyte in said test sample from said detectable signal. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for detecting the presence or an amount of an analyte in a test sample comprising providing:
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(a) an analytical device comprising a first hydrophobic material and a second hydrophilic material, said first hydrophobic material consisting of;
acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing and containing a reagent therein; said first hydrophobic material allowing gaseous exchange in and out of a portion of said track; and said track having at least one surface of said first hydrphobic material modified to create said second hydrophilic material by introducing at least one hydrophilic group onto said first hydrophobic surface, said hydrophilic group consisting of;
hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates; and(b) adding said test sample to said housing through said inlet port; said test sample and said reagent producing a detectable signal upon mixing; and (c) determining the presence or an amount of an analyte in said test sample from said detectable signal. - View Dependent Claims (8, 9, 10, 11)
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12. A method for detecting the presence or an amount of an analyte in a test sample comprising providing:
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(a) a housing having a first layer, a core layer, and a second layer, said core layer made of a hydrophobic material containing a track of predetermined width and length and having at least one reagent therein, said track having a sidewall defining the boundaries for flow of said test sample, said first and second layers being impermeable to said test sample; at least one of said first or second layers having a hydrophilic surface; said housing containing an inlet port, said inlet port accessing said track, at least one of said first layer, second layer, or core layer made of a porous material that will vent gases in and out of a portion of said track; (b) adding said test sample to said housing through said inlet port; said test sample and said reagent producing a detectable signal upon mixing; and (c) determining the presence or an amount of an analyte in said test sample from said detectable signal. - View Dependent Claims (13, 14, 15, 16)
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17. An analytical device for detecting the presence or an amount of an analyte in a test sample, comprising:
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a housing made of a hydrophobic material, said hydrophobic material consisting of;
acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within housing; said track having at least one hydrophobic surface modified to create a hydrophilic surface by introducing at least one hydrophilic group onto said hydrophobic surface, said hydrophilic group consisting of;
hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates; andsaid hydrophobic material being impermeable to said test sample and allowing gaseous exchange in and out of a portion of said track. - View Dependent Claims (18, 19, 20, 21, 22, 23)
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24. An analytical device for detecting the presence or an amount of an analyte in a test sample comprising:
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a housing made of a first hydrophobic material and a second hydrophilic material, said first hydrophobic material consisting of;
acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing; said first hydrophobic material allowing gaseous exchange in and out of a portion of said track; and said track having at least one surface of said first hydrophobic material modified to create said second hydrophilic material by introducing at least one hydrophilic group onto said first hydrophobic surface, said hydrophilic group consisting of;
hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. An analytical device for detecting the presence or an amount of an analyte in a test sample comprising:
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a housing having a first layer, a core layer, and a second layer, said core layer made of a hydrophobic material containing a track of predetermined width and length, said track having a sidewall defining the boundaries for flow of said test sample, said first and second layers being impermeable to said test sample; at least one of said first or second layers having a hydrophilic surface; and said housing containing an inlet port, said inlet port accessing said track of, at least one of said first layer, second layer, or core layer made of a porous material that will vent gases in and out of a portion of said track. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44)
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Specification