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Publication Number
US-8119393-B2
Publication Date
2012-02-21
Expiration Date
Abstract
A membrane array used to detect one or more analytes from a small sample of fluid with high sensitivity is provided. The membrane array can be employed in various analytical devices and is especially useful for identifying analytes from whole blood with minimal or negligible background interference.
Core Innovation
The invention relates to a membrane array and an analytical device for detecting one or more analytes in a fluid sample containing red blood cells. The array includes a separation membrane and an analytical membrane in fluid communication with one another, where the separation membrane has a pore size greater than a red blood cell up to about 8 μm and overlaps at least a portion of the analytical membrane. The pore size condition retards red blood cells with negligible hemolysis while enabling detection on the analytical membrane.
The analytical membrane has a lower porosity than the separation membrane. The device and array use a small volume of about 10 μL to 50 μL of sample. The system is described as an improved immunoassay membrane array arranged with a stair-step, non-planar configuration of overlapping porous membranes, with pore size and/or porosity decreasing across the steps to retard red blood cells with minimal hemolysis while enabling rapid, high-sensitivity detection.
The disclosed device includes an analytical device housing and a sample-flow channel adapted to provide uniform horizontal capillary flow into the array, with sample application means that can include a removable cap or immersion entry. The system includes functional membrane roles for sample retardation and for analytical detection, including a detection reagent layer and a capture reagent layer, and may include an optional control line.
Claims Coverage
The independent claims cover two inventive features centered on the same membrane relationship and small sample volume.
Membrane array with separation membrane and lower-porosity analytical membrane
A membrane array for detecting one or more analytes in a fluid sample containing red blood cells, comprising a separation membrane and an analytical membrane in fluid communication with one another, where the separation membrane has a pore size greater than a red blood cell to about 8 μm such that it retards red blood cells with negligible hemolysis and overlaps at least a portion of the analytical membrane, and the analytical membrane has a lower porosity than the separation membrane, wherein a small volume of about 10 μL to 50 μL of sample is used.
Analytical device with separation membrane overlapping a lower-porosity analytical membrane
An analytical device for detecting one or more analytes in a fluid sample containing red blood cells, comprising a membrane array having a separation membrane and an analytical membrane in fluid communication with one another, where the separation membrane has a pore size of greater than a red blood cell and about 8 μm such that it retards red blood cells with negligible hemolysis and overlaps at least a portion of the analytical membrane, and the analytical membrane has a lower porosity than the separation membrane, wherein a small volume of about 10 μL to 50 μL of sample is used.
Across the independent claims, the inventive coverage centers on configuring an overlapping separation membrane and an analytical membrane with a specified pore-size and porosity relationship that retards red blood cells with negligible hemolysis while supporting detection from small sample volumes.
Stated Advantages
Retards red blood cells with negligible hemolysis.
Enables detection using a small volume of about 10 μL to 50 μL.
Enables rapid, high-sensitivity detection.
Documented Applications
Immunoassay detection of troponin I (cTnI).
Immunoassay detection of procalcitonin (PCT).
Detecting one or more analytes selected from calcitonin, myoglobin, troponin T (cTnT), troponin I (cTnI), CK-MB, hCG, LH, cancer antigens, viral/bacterial/fungal infection antigens, drugs, and combinations thereof.
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