Assay Device, System and Method
2 Assignments
0 Petitions
Accused Products
Abstract
A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin. To use these systems, the user simply applies a small sample (700) to the membrane (218) and closes a door (10) of the detection system over the strip (200) such that the door triggers the release of the eluting agent. No sample pre-treatment is required. The preferably handheld system (100) is a simple and convenient monitoring tool for the user, such as a diabetic patient who must monitor blood glucose on an on-going basis. While the systems are useful in the monitoring of blood glucose, they may be used for treating a sample other than blood and detecting an analyte other than an analyte in blood.
39 Citations
100 Claims
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1-79. -79. (canceled)
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80. A system for treating a blood sample that comprises at least one analyte, the system comprising:
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a strip comprising a membrane, the membrane comprising; a receiving portion for receiving the blood sample; a first location having a first reagent disposed thereon, wherein the first reagent lyses cells in the blood sample; and a second location having a second reagent immobilized thereon, wherein the second reagent captures the at least one analyte of the blood sample; an eluting agent, wherein the eluting agent flows downstream along the membrane, contacts the blood sample, and elutes the at least one analyte from the first location to the second location; a detecting means for detecting the level of the at least one analyte captured at the second location. - View Dependent Claims (81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99)
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100. A system for quantitative measurement of percent glycated hemoglobin in a blood sample, the system comprising:
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a strip comprising a membrane, the membrane comprising; a receiving portion for receiving the blood sample; a first location having a first reagent disposed thereon, the first reagent comprising an ionic detergent and a non-ionic detergent, wherein the first reagent lyses cells in the blood sample; and a second location having a second reagent immobilized thereon, wherein the second reagent captures glycated hemoglobin of the blood sample; a third location having a third reagent immobilized thereon, wherein the third reagent captures non-glycated hemoglobin of the blood sample; an eluting agent, wherein the eluting agent flows downstream along the membrane, contacts the blood sample, and elutes the glycated hemoglobin from the first location to the second location, and elutes the non-glycated hemoglobin from the first location to the third location; detecting means for obtaining a first optical signal that relates to a level of the glycated hemoglobin captured at the second location, and for obtaining a second optical signal that relates to a level of the non-glycated hemoglobin captured at the third location.
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Specification