Reflux device for detection of analytes in samples
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Abstract
Devices for detection of analytes in samples of various complexities are provided. The devices allow reflux of liquid into a sample-receiving member, providing for suitable analyte dilution and preventing leakage of cells or particulate material into the signal generation member. In one aspect, the devices are used to test analytes in biological samples such as blood, serum, plasma or other body fluids. In another aspect, the devices are used to test samples from tissues, such as organ tissues, tumor samples, or other body parts. In a further aspect, the devices are used to test microbial samples, food samples, or any other sample from which the analyte of interest can be captured into the reflux device.
Core Innovation
The invention relates to a reflux-based point-of-care diagnostic device in which a sample-receiving port is adjacent to a sample-collecting pad to allow a sample to be placed at a sample-collecting point, and wherein a detection zone produces a signal in response to a sample analyte interacting with the detection zone. The device is configured to cause the sample analyte to travel from the sample-collecting point to the detection zone in a downstream direction.
A first liquid reservoir is placed in the downstream direction from the sample-receiving port and at a level above the sample-collecting pad, with the first liquid in a predetermined amount. When the first liquid is released, the first liquid travels in an upstream direction, opposite to the downstream direction, to the sample-collecting point and then travels in the downstream direction after reaching the sample-collecting point.
A second liquid reservoir placed in the downstream direction from the first reservoir provides a second liquid that, when released, travels in the downstream direction. The described device behavior uses liquid reflux upstream opposite the downstream sample flow to dilute analytes and wash while preventing cells/particulates from entering or contaminating the detection/signal-generation region, enabling consistent operation despite variable biological sample volumes.
Claims Coverage
The independent claims are directed to a sample-processing detection device with downstream transport from a sample-collecting point to a detection zone and controlled liquid release that travels upstream opposite sample flow and then downstream, using one or more liquid reservoirs. Four inventive features are identified across the independent claims.
Upstream-and-downstream sample analyte transport with reflux liquid
A detection zone produces a signal in response to a sample analyte from the sample interacting with the detection zone, wherein the device is configured to cause the sample analyte to travel from the sample-collecting spot to the detection zone in a downstream direction.
First liquid reservoir that releases upstream to the sample-collecting point then downstream
A first liquid reservoir placed in the downstream direction from the sample-receiving port and at a level above the sample-collecting pad, wherein said first liquid reservoir has a first liquid in a predetermined amount and the device is configured such that when the first liquid is released, the first liquid travels in an upstream direction, opposite to the downstream direction, to the sample-collecting point and then travels in the downstream direction after reaching the sample-collecting point.
Second liquid reservoir downstream
A second liquid reservoir placed in the downstream direction from the first reservoir, wherein said second liquid reservoir has a second liquid and the device is configured such that when the second liquid is released, the second liquid travels in the downstream direction.
Liquid reservoir with reflux from downstream position
A liquid reservoir placed in the downstream direction from the sample-receiving port and at a level above the sample-collecting pad, wherein said liquid reservoir has a liquid in a predetermined amount and the device is configured such that when the liquid is released, the liquid travels in an upstream direction, opposite to the downstream direction, to the sample-collecting point and then travels in the downstream direction after reaching the sample-collecting point.
Both independent claims require a reflux-capable liquid release mechanism in which liquid moves upstream opposite the downstream path to a sample-collecting point and then returns downstream, combined with a detection zone that generates a signal after downstream travel of the sample analyte from the sample-collecting spot.
Stated Advantages
Enables consistent operation across variable biological sample volumes by using reflux to dilute analytes and wash.
Prevents cells/particulates from entering or contaminating the detection/signal-generation region.
Documented Applications
Anti-adalimumab (ADA) immunoassay using chimeric-adalimumab (HCA204) and controls, including tests where reflux mitigates red blood cell leakage/background under varying blood volumes.
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