Self-performing immunochromatographic device
First Claim
1. In a chromatographic strip binding assay device, for detecting the presence or amount of an analyte in a patient sample, wherein a visually detectable plus sign (+) develops to indicate a positive test PG,38 result or a visually detectable minus sign (-) develops to indicate a negative test result, the device comprising:
- a chromatographic strip having a length and narrow width capable of conveying fluids in a fluid flow direction generally parallel to the length of said strip, said strip comprisinga sample contact region whereat a fluid patient sample and other assay reagents may be contacted with said strip, anda testing region disposed on said strip at a downstream location from said sample contact region, said testing region comprisinga patient test bar defined by a first capture reagent, specific for the analyte, immobilized on said strip in a generally rectangular configuration, anda procedural control bar defined by a second capture reagent, specific for an assay label, immobilized on said strip in a generally rectangular configuration, said patient test bar and said procedural control bar intersecting each other in a generally perpendicular manner;
wherein the the testing region improvement comprises;
said patient test bar and said procedural control bar each being immobilized on said strip in an angled orientation with respect to the fluid flow direction of said strip to minimize the distance travelled by an added migrating fluid across both said patient test bar and said procedural control bar.
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Accused Products
Abstract
Improved chromatographic strip binding assay devices are provided for determining the presence or amount of an analyte present in a patient sample. Assay label reagents interact with capture reagents immobilized in a testing region on the strip substrate to generate a visually detectable image indicative of the test result. The test result images include a minus sign (-) to indicate a negative test result for analyte which image is generated if the suspect analyte is absent in the patient sample and a plus sign (+) to indicate a positive test result for analyte which image is generated if the suspect analyte is present or is present at a pre-determined concentration in the patient sample. The immobilized capture reagents responsible for the location and configuration of the test result images are applied to the strip at an angled orientation with respect to the fluid flow direction of the strip to ensure that sharp substantially complete test result images are formed during performance of the assay. The devices provide substantially self-performing assays having inherently clear test results which are not subject to misinterpretation by the skilled or untrained user.
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Citations
18 Claims
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1. In a chromatographic strip binding assay device, for detecting the presence or amount of an analyte in a patient sample, wherein a visually detectable plus sign (+) develops to indicate a positive test PG,38 result or a visually detectable minus sign (-) develops to indicate a negative test result, the device comprising:
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a chromatographic strip having a length and narrow width capable of conveying fluids in a fluid flow direction generally parallel to the length of said strip, said strip comprising a sample contact region whereat a fluid patient sample and other assay reagents may be contacted with said strip, and a testing region disposed on said strip at a downstream location from said sample contact region, said testing region comprising a patient test bar defined by a first capture reagent, specific for the analyte, immobilized on said strip in a generally rectangular configuration, and a procedural control bar defined by a second capture reagent, specific for an assay label, immobilized on said strip in a generally rectangular configuration, said patient test bar and said procedural control bar intersecting each other in a generally perpendicular manner; wherein the the testing region improvement comprises;
said patient test bar and said procedural control bar each being immobilized on said strip in an angled orientation with respect to the fluid flow direction of said strip to minimize the distance travelled by an added migrating fluid across both said patient test bar and said procedural control bar. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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Specification