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US 10,761,030 B2Granted
System and methods for analyte detection
AssigneeLabrador Diagnostics LLC
InventorsElizabeth A. Holmes, Ian Gibbons, Timothy M. Kemp, John Howard, Shaunak Roy
Life of this patent
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Abstract
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.
Claims22
A method for detecting an analyte in a bodily fluid sample of a subject, comprising:
- providing a cartridge comprising a sample collection unit and an assay assembly, the sample collection unit configured to receive the bodily fluid sample, and the assay assembly comprising a reaction site containing a dry reactant to be liquefied prior to completing an assay, the dry reactant configured to react with the analyte in the bodily fluid sample;
- inserting the cartridge containing the bodily fluid sample into a reader assembly, the cartridge comprising an identifier corresponding to a protocol to be used with the cartridge, the protocol including instructions to perform the assay, wherein the reader assembly is configured to receive the cartridge inside the reader assembly;
- receiving at the reader assembly a selected protocol from an external device, wherein the selected protocol is selected from a plurality of protocols in response to detecting the identifier of the cartridge;
- executing the selected protocol to perform the assay such that an actuating element causes movement of the bodily fluid sample to the reaction site according to the selected protocol for reaction with the reactant contained within the reaction site, wherein the assay assembly yields a detectable signal generated from the analyte in the sample that indicates a concentration of the analyte;
- detecting the detectable signal using a detector based on the selected protocol;
- and
- transmitting an indication that the detectable signal was detected from the detector to the external device.
4 more elements
A method for detecting an analyte in a bodily fluid sample of a subject, comprising:
- providing a fluidic device comprising a sample collection unit and an assay assembly, the sample collection unit configured to receive the bodily fluid sample, and the assay assembly comprising a reaction site containing a dry reactant to be contacted with liquid prior to completing an assay, the dry reactant configured to react with the analyte in the bodily fluid sample after being contacted with liquid;
- inserting the fluidic device containing the bodily fluid sample into a reader assembly, the fluidic device comprising an identifier corresponding to a protocol to be used with the fluidic device, the protocol including instructions to perform the assay, wherein the reader assembly is configured to receive the fluidic device inside the reader assembly;
- receiving at the reader assembly a selected protocol from an external device, wherein the selected protocol is selected from a plurality of protocols in response to detecting the identifier of the fluidic device;
- executing the selected protocol to perform the assay such that an actuating element causes movement of the bodily fluid sample within the fluidic device to the reaction site according to the selected protocol for reaction with the reactant contained within the reaction site after the reactant is contacted with liquid, wherein the assay assembly yields a detectable signal generated from the analyte in the sample, indicating the presence of the analyte;
- detecting the detectable signal using a detector;
- and
- transmitting from the detector to the external device an indication that the detectable signal was detected.
4 more elements
A method of testing for an analyte in a bodily fluid sample of a subject, comprising:
- providing a fluidic device comprising a sample collection unit and an assay assembly, the sample collection unit configured to receive the bodily fluid sample, and the assay assembly comprising a reaction site containing a dry reactant to be contacted with liquid prior to completing an assay, the dry reactant configured to react with the analyte, if present, in the bodily fluid sample after being contacted with liquid;
- inserting the fluidic device containing the bodily fluid sample into a reader assembly, the fluidic device comprising an identifier corresponding to a protocol to be used with the fluidic device, the protocol including instructions to perform the assay, wherein the reader assembly is configured to receive the fluidic device inside the reader assembly;
- receiving at the reader assembly a selected protocol from an external device, wherein the selected protocol is selected from a plurality of protocols in response to detecting the identifier of the fluidic device;
- executing the selected protocol to perform the assay such that an actuating element causes movement of the bodily fluid sample within the fluidic device to the reaction site according to the selected protocol for reaction with the reactant contained within the reaction site after the reactant is contacted with liquid if the analyte is present, wherein the assay assembly does not yield a detectable signal that indicates the presence of the analyte;
- and
- transmitting to the external device an indication that no detectable signal was detected.
3 more elements
Dependencies are inferred from the claim text.