Assay Device, System and Method

• US 20100190268A1
• Filed: 02/25/2010
• Published: 07/29/2010
• Est. Priority Date: 11/05/2002
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jina, Arvind N.
• Application Number:
  US12/713,066
• Publication Number:
  US 20100190268A1
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/721 Haemoglobin
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

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.

Claims

1-79. -79. (canceled)

80. A system for treating a blood sample that comprises at least one analyte, the system comprising:

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.

81. The system of claim 80, wherein the first reagent comprises at least one detergent.

82. The system of claim 80, wherein the first reagent comprises a non-ionic detergent and an ionic detergent.

83. The system of claim 80, wherein the membrane has a property selected from wicking functionality, capillary functionality, and porosity.

84. The system of claim 80, wherein the first reagent is selected from a detergent or a hypotonic solution.

85. The system of claim 80, wherein the eluting agent is selected from a buffer and a solvent.

86. The system of claim 80, wherein the second reagent is selected from an antibody and a chemical reagent comprising at least one ligand for binding the at least one analyte

87. The system of claim 80, wherein the at least one analyte is glycated hemoglobin.

88. The system of claim 80, wherein the second reagent captures a first analyte of the blood sample;

and

wherein the membrane further comprises a third location having a third reagent immobilized thereon, wherein the third reagent captures a second analyte of the blood sample.

89. The system of claim 88, wherein the third location is downstream relative to the second location.

90. The system of claim 88, wherein the third reagent is selected from an antibody, a glycoprotein, and a chemical reagent comprising at least one ligand for binding the second analyte.

91. The system of claim 88, wherein the first analyte is glycated hemoglobin and the second analyte is non-glycated hemoglobin.

92. The system of claim 80, wherein the strip comprises a means for containing the eluting agent.

93. The system of claim 92, wherein the means is selected from an absorbent pad, a pouch, and a blister.

94. The system of claim 92, wherein eluting the at least one analyte comprises releasing the eluting agent from the means.

95. The system of claim 94, wherein the releasing is selected from breaking an integrity of the means, and applying a pressure to the means.

96. The system of claim 80, wherein the first location is downstream relative to the receiving portion for receiving the blood sample.

97. The system of claim 80, wherein the detecting means comprises means for obtaining an optical signal that relates to the amount of the at least one analyte captured at the second location.

98. The system of claim 80, wherein the eluting agent is allowed to flow downstream when a release condition is met.

99. The system of claim 80, wherein the first location is at or proximate to the receiving portion for receiving the blood sample.

100. A system for quantitative measurement of percent glycated hemoglobin in a blood sample, the system comprising:

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.