Assay device, system and method
First Claim
1. A system for treating a blood sample that comprises at least one analyte, comprising:
- a strip comprising a membrane, the membrane comprising a receiving portion for receiving the blood sample;
a first reagent disposed on the membrane at a first location at or proximate to the receiving portion, the first reagent sufficient to lyse cells in the blood sample;
an eluting agent disposed on the strip upstream relative to the first location, the eluting agent sufficient to elute hemoglobin in the blood sample; and
a second reagent disposed on the membrane at a second location downstream relative to the first location, the second reagent sufficient to capture an analyte of the hemoglobin in the blood sample.
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.
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Citations
92 Claims
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1. A system for treating a blood sample that comprises at least one analyte, comprising:
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a strip comprising a membrane, the membrane comprising a receiving portion for receiving the blood sample;
a first reagent disposed on the membrane at a first location at or proximate to the receiving portion, the first reagent sufficient to lyse cells in the blood sample;
an eluting agent disposed on the strip upstream relative to the first location, the eluting agent sufficient to elute hemoglobin in the blood sample; and
a second reagent disposed on the membrane at a second location downstream relative to the first location, the second reagent sufficient to capture an analyte of the hemoglobin in the blood sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 90)
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14. A system for determining at least one analyte in a blood sample, comprising:
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a subsystem for treating the blood sample, the treating subsystem comprising;
a strip comprising a membrane, the membrane comprising a first receiving portion for receiving the blood sample;
a first reagent disposed on the membrane at a first location at or proximate to the first receiving portion, the first reagent sufficient to lyse cells in the blood sample;
an eluting agent disposed on the strip upstream relative to the first location, the eluting agent sufficient to elute hemoglobin in the blood sample; and
a second reagent disposed on the membrane at a second location downstream relative to the first location, the second reagent sufficient to capture an analyte of the hemoglobin in the blood sample; and
a subsystem for detecting the at least one analyte, the detecting subsystem comprising;
a second receiving portion for receiving the treating subsystem;
at least one source of light of at least one predetermined wavelength directed toward at least one location of the first location and the second location when the treating subsystem is received in the second receiving portion; and
at least one light detector for receiving light reflected from at least one location of the first location and the second location when the treating subsystem is received in the second receiving portion. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. A method of treating a blood sample that comprises at least one analyte, comprising:
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providing 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 sufficient to lyse cells in the blood sample; and
a second location downstream relative to the first location having a second reagent disposed thereon, the second reagent sufficient to capture an analyte of the hemoglobin in the blood sample;
providing an eluting agent disposed on the strip upstream relative to the first location, the eluting agent sufficient to elute hemoglobin in the blood sample;
applying the blood sample to the receiving portion of the membrane; and
allowing the eluting agent to flow downstream along the membrane. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 91)
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53. A method for determining at least one analyte in a blood sample, comprising:
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providing a subsystem for treating the blood sample, the treating subsystem comprising;
a strip comprising a membrane, the membrane comprising a first receiving portion for receiving the blood sample;
a first location having a first reagent disposed thereon, the first reagent sufficient to lyse cells in the blood sample; and
a second location downstream relative to the first location having a second reagent disposed thereon, the second reagent sufficient to capture an analyte of the hemoglobin in the blood sample;
providing an eluting agent disposed on the strip upstream relative to the first location, the eluting agent sufficient to elute hemoglobin in the blood sample;
providing a subsystem for detecting the at least one analyte, the detecting subsystem comprising;
a second receiving portion for receiving the treating subsystem;
at least one source of light of at least one predetermined wavelength directed toward at least one location of the first location and the second location when the treating subsystem is received in the second receiving portion; and
at least one light detector for receiving light reflected from at least one location of the first location and the second location when the treating subsystem is received in the second receiving portion;
receiving the treating subsystem in the second receiving portion of the detecting subsystem;
applying the blood sample to the first receiving portion of the membrane;
allowing the eluting agent to flow downstream along the membrane;
directing light toward at least one location of the first location and the second location; and
receiving light reflected from at least one location of the first location and the second location at least one light detector. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 92)
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69-79. -79. (canceled)
Specification