Simultaneous spot test and storage of blood samples
Inventors
Assignees
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Publication Number
US-11772097-B2
Publication Date
2023-10-03
Expiration Date
Abstract
A blood sample collection and/or storage device includes a two-piece housing that encompasses a port at which a fingertip blood sample is collected. After the sample is taken, the two-piece housing is moved to a closed position to protect the sample for storage and optionally process the sample within the housing. The housing may also be opened to access the stored sample for further processing.
Core Innovation
The invention provides a biological fluid sample collection device with a housing comprising a first housing section and a second housing section that are configurable from a first position to a second position by moving the first housing section and the second housing section together. In the first position, the sample collection well is positioned on an exterior surface of the housing and is configured to receive the sample from a user; in the second position, the sample collection well is fully enclosed within the housing and is inaccessible to the user.
A capillary is in fluid communication with the sample collection well and is configured to hold a predetermined volume of a sample comprising one or more analytes. The device includes a medium in fluid communication with the capillary that is configured to retain at least a portion of the sample or a derivative thereof, and the medium comprises a conjugate configured to bind the one or more analytes to perform a test, including an immunoassay strip comprising the conjugate.
A reagent configured to be dispensed onto the medium is provided, and the device includes a mechanically actuated fluid controller configured to cause a predetermined volume of the sample to be dispensed from the capillary onto the medium when the housing is moved from the first position to the second position. When the housing is moved from the first position to the second position, the reagent and the sample are dispensed onto the medium and are mixed to initiate performance of the test, and the result is indicated on at least a portion of the medium.
Claims Coverage
The document contains two independent claims, a device claim and a method claim, with five inventive features focused on the two-position housing, predetermined metered volume via a capillary, reagent dispensing and mixing with a conjugate-containing medium, and assay initiation and result indication when the housing moves from a first position to a second position.
Two-position enclosed sample collection well
A housing configurable from a first position to a second position by moving the first housing section and the second housing section together, where the sample collection well is on an exterior surface in the first position and fully enclosed and inaccessible to the user in the second position.
Predetermined-volume capillary dispensing
A capillary in fluid communication with the sample collection well, configured to hold a predetermined volume of the sample comprising one or more analytes and to dispense that predetermined volume from the capillary when the housing is moved from the first position to the second position.
Conjugate-containing medium including immunoassay strip
A medium in fluid communication with the capillary configured to retain at least a portion of the sample or a derivative thereof, comprising a conjugate configured to bind the one or more analytes to perform a test, wherein the medium comprises an immunoassay strip comprising the conjugate.
Mechanically actuated fluid controller for coordinated dispensing and mixing
A mechanically actuated fluid controller configured to cause the predetermined volume of the sample to be dispensed from the capillary onto the medium when the housing is moved from the first position to the second position, wherein a reagent configured to be dispensed onto the medium is dispensed and mixed with the sample when dispensed onto the medium to initiate performance of the test.
Assay performance with result indication
A method of performing an assay on a blood sample using a blood sample collection device with a first position exterior well and a second position enclosed inaccessible well, comprising drawing a portion of the blood sample into the capillary, moving the housing to actuate the mechanically actuated fluid controller to dispense the sample and reagent onto the medium, performing an assay on at least a portion of the blood sample dispensed onto the medium with the conjugate configured to bind the one or more analytes, and indicating the result of the assay on at least a portion of the medium.
Across the independent claims, the core inventive scope centers on using a housing that moves from an exterior, user-accessible sample collection well to a fully enclosed, user-inaccessible state while a capillary holds and dispenses a predetermined sample volume. A conjugate-containing medium, including an immunoassay strip, retains the sample or derivative, and a mechanically actuated fluid controller coordinates reagent dispensing so that the reagent and sample are dispensed and mixed on the medium to initiate performance of the test, followed by indicating the assay result.
Stated Advantages
Documented Applications
No documented applications found
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