Integrated buffer dual-path immunoassay device
Inventors
Assignees
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Publication Number
US-9476875-B2
Publication Date
2016-10-25
Expiration Date
Abstract
A test device for use with a liquid solution includes a housing that houses a plurality of sorbent strips. At least one strip has a location for receiving the solution. The housing defines at least an opening in said housing wherein said opening is aligned with the location for receiving the solution. The device includes a sealed reservoir filled with the liquid solution, the sealed reservoir being disposed in alignment with the opening and coupled to the housing. The device includes an opener coupled to the housing. The opener is arranged to rotate from a first position, in which the opener is not in contact with the sealed reservoir, to a second position, in which the opener causes the sealed reservoir to effect a release of the solution from the reservoir and into the opening and onto the sorbent strip housed within the housing.
Core Innovation
The test device comprises a housing containing separate sorbent strips that define distinct migration paths for a liquid sample and a solution with a conjugate. These distinct migration paths meet at an observable test site containing an immobilized ligand-binding mechanism viewable through a housing result window. The housing further includes openings aligned with sample and buffer receiving locations on the sorbent strips.
The device incorporates a sealed, fixed-volume solution reservoir aligned with a housing opening and an opener rotatably coupled to the housing. The opener rotates from a position out of contact with the reservoir to a position that causes the reservoir to release solution through the opening onto a sorbent strip. This structural arrangement reduces user-dependent volume error during operation in ligand detection assays, including HIV and tuberculosis assays.
Claims Coverage
The claims define three inventive features across two independent test device claims and one independent method claim.
Test device with a rotatable opener and sealed reservoir
The claim covers a housing containing sorbent strips, an opening aligned with a solution-receiving location, a sealed solution reservoir aligned with the opening, and an opener rotatable from a position out of contact with the reservoir to a position that causes the release of solution through the opening onto a sorbent strip.
Test device with separate sample and solution migration paths
The claim covers a first sorbent strip defining a migration path for solution and conjugate and a distinct second sorbent strip defining a migration path for a liquid sample, wherein the strips touch at an immobilized ligand-binding test site viewable through a housing window, in combination with a sealed reservoir and a rotatable opener.
Method of releasing solution using a rotatable opener
The claim covers providing a test device comprising a housing, sorbent strips, an aligned opening, a sealed solution reservoir, and an opener, and rotating the opener from a first position out of contact with the reservoir to a second position that causes the reservoir to release solution through the opening onto a sorbent strip.
The independent claims cover a test device with a sealed reservoir and rotatable opener assembly, a dual-strip configuration defining separate migration paths that meet at a shared test site, and a method of releasing solution by rotating the opener.
Stated Advantages
The integrated sealed, fixed-volume buffer reservoir and rotatable opener reduce user-dependent volume error.
The disclosure reports increased sensitivity compared with prior-art tests: at least eight-fold for TB and approximately four-fold for HIV.
Documented Applications
Determining the presence of a ligand in a liquid sample using a test device with a conjugate having a marker and a test site with an immobilized ligand-binding mechanism.
HIV-1 and HIV-2 assays, including HIV confirmation tests.
Tuberculosis assays, including comparative tuberculosis control testing.
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