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US 11,143,647 B2Granted
Modular point-of-care devices, systems, and uses thereof
AssigneeLabrador Diagnostics LLC
InventorsTammy Burd, Ian Gibbons, Elizabeth A. Holmes, Gary Frenzel, Anthony Joseph Nugent
Life of this patent
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Abstract
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
Claims27
A method of detecting at least two analytes in a biological sample using a reader assembly, the method comprising:
- receiving into the reader assembly a cartridge comprising a sample unit containing the biological sample and an array of reagent units, wherein a reagent unit of the array of reagent units comprises a diluent;
- forming a diluted biological sample by combining the diluent with the biological sample;
- inserting a tip of a first assay unit directly coupled to a fluid transfer device of the reader assembly into the sample unit such that the first assay unit and the sample unit are in fluid communication via the tip;
- drawing, by means of a fluid transfer device in the reader assembly, at least a portion of said diluted biological sample from said sample unit to the first assay unit to provide a first sample portion in the first assay unit;
- inserting a tip of a second assay unit directly coupled to the fluid transfer device into the sample unit such that the second assay unit and the sample unit are in fluid communication via the tip of the second assay unit;
- drawing, by means of the fluid transfer device in the reader assembly, a second portion of said diluted biological sample from said sample unit into the second assay unit to provide a second sample portion in the second assay unit, wherein said second sample portion is not in fluid communication with said first sample portion;
- performing a first assay for detecting a presence of a first analyte in said first sample portion in the first assay unit;
- and
- performing a second assay for detecting a presence of a second analyte in said second sample portion.
6 more elements
A method of detecting at least two analytes in a biological sample using a reader assembly, the method comprising:
- receiving a cartridge comprising a frame holding an array of individual, addressable reagent units and a sample unit in the reader assembly, wherein the sample unit contains the biological sample;
- forming a diluted biological sample by combining the biological sample with a diluent;
- moving the cartridge into fluid communication with a first assay unit via a tip of the first assay unit;
- drawing, by means of a fluid transfer device of the reader assembly that is directly coupled to the first assay unit, at least a portion of the diluted biological sample from the sample unit of the cartridge to the first assay unit to provide a first sample portion in the first assay unit;
- moving the cartridge into fluid communication with a second assay unit via a tip of the second assay unit;
- drawing, by means of the fluid transfer device of the reader assembly that is directly coupled to the second assay unit, at least a portion of the diluted biological sample from the sample unit of the cartridge to the second assay unit to provide a second sample portion in the second assay unit, wherein drawing the diluted biological sample into the first assay unit and drawing the diluted biological sample into the second assay unit occurs simultaneously;
- performing a first assay for detecting a presence of a first analyte in the first sample portion in the first assay unit;
- and
- performing a second assay for detecting a presence of a second analyte in the second sample portion in the second assay unit.
6 more elements
A method of detecting at least two analytes in a biological sample using a reader assembly, the method comprising:
- receiving a cartridge comprising an array of individual, addressable reagent units and a sample unit in the reader assembly, wherein the sample unit contains the biological sample;
- placing a first assay unit in fluid communication with the cartridge, wherein the first assay unit comprises an interior reaction site comprising an immobilized reagent;
- drawing, by means of a fluid transfer device of the reader assembly, a portion of the biological sample from the sample unit of the cartridge to the first assay unit such that a first analyte binds to the immobilized reagent, wherein the first assay unit is directly coupled to the fluid transfer device:
- placing the first assay unit into fluid communication with a first reagent unit of the array of reagent units;
- drawing a cartridge reagent from the first reagent unit into the first assay unit such that the cartridge reagent reacts with the bound first analyte to produce a signal indicative of a presence of the first analyte;
- placing a second assay unit in fluid communication with the cartridge, wherein the second assay unit comprises a second interior reaction site comprising a second immobilized reagent;
- drawing, by means of the fluid transfer device of the reader assembly, a portion of the biological sample from the sample unit of the cartridge to the second assay unit such that a second analyte in the biological sample binds to the second immobilized reagent, wherein the second assay unit is directly coupled to the fluid transfer device;
- placing the second assay unit in fluid communication with a second reagent unit of the array of reagent units;
- drawing a second cartridge reagent from the second reagent unit into the second assay unit such that the second cartridge reagent reacts with the bound second analyte to produce a signal indicative of a presence of the second analyte;
- and
- detecting a signal indicative of the presence of the first analyte and a signal indicative of the second analyte by a detection device.
8 more elements
Dependencies are inferred from the claim text.