Developer solution vial
Inventors
FISCHL, Mark • Kardos, Keith • Nemeth, Attila • EMRICK, Mark
Assignees
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Publication Number
US-12214351-B2
Publication Date
2025-02-04
Expiration Date
Abstract
The invention provides a developer solution vial and methods of its use to diagnose diseases using a sampling and/or assay device, for example, for use with a lateral flow assay (LFA) device. The developer solution vial may include any container that is capable of holding developer solution. The developer solution vial is keyed to the sampling and/or assay device. The developer solution vial minimizes the amount of developer solution required for accurate fluid flow assay testing.
Core Innovation
A developer solution vial is provided for use with an assay device for a point-of-care diagnosis, the vial having a cavity to contain a developer solution and an elongated housing surrounding the cavity with an opening extending to the cavity. The vial includes a mating portion configured to interface with a head of a sampling device and/or a collection pad of the assay device.
The mating portion is defined in outward order from the cavity opening to include an extraction portion having a rounded semi-circular cross-sectional shape that protrudes into the cavity. The mating portion also includes a sampling device interface portion to accept the sampling device into the cavity to elute a sample into the developer solution, and a seating portion that mates with a resting surface of the collection pad or a housing of the collection pad to prevent compression of a sampling portion of the collection pad when in a resting position in the developer solution.
The concept is directed to using a reduced-volume developer solution vial with point-of-care lateral flow assays while improving contact for elution and wicking into a submerged collection pad. Example contexts include respiratory disease testing, including COVID-19 antigen detection and SARS nucleocapsid antigen detection.
Claims Coverage
The document contains one independent claim that defines the core structural and functional coverage of a developer solution vial for point-of-care diagnosis, with several dependent claims refining structural features, volume ranges, material properties, and method workflow details. The inventive features are the elongated housing with cavity and mating portion, the extraction portion for sample recovery, the sampling device interface portion, and the seating portion configured to prevent compression of a collection pad sampling portion.
Elongated developer solution vial cavity with opening and mating portion
A developer solution vial includes a cavity to contain a developer solution and an elongated housing surrounding the cavity, the elongated housing comprising an opening extending to the cavity and a mating portion to interface with a head of a sampling device and/or a collection pad of the assay device.
Rounded semi-circular extraction portion protruding into the cavity
The mating portion comprises, in outward order from cavity opening, an extraction portion comprising a rounded semi-circular cross-sectional shape that protrudes into the cavity.
Sampling device interface portion for eluting a sample into the developer solution
The mating portion comprises a sampling device interface portion to accept the sampling device into the cavity to elute a sample into the developer solution.
Seating portion to prevent compression of a collection pad sampling portion
The mating portion comprises a seating portion to mate with a resting surface of the collection pad of the assay device or housing of the collection pad of the assay device to prevent compression of a sampling portion of the collection pad when in a resting position in the developer solution.
Developer solution volume range in the cavity
The developer solution vial includes between 50 and 1000 microliters of a developer solution in its cavity.
Cavity volume range
The developer solution vial has a cavity volume between 75 and 1500 microliters (L).
Extraction interface configured to evenly receive head sides based on sampling device width
The developer solution vial has an extraction portion that bottlenecks a sampling device interface to evenly receive sides of a head based on a width of the sampling device.
Transparent material vial
The developer solution vial is made of a transparent material.
Assay workflow with immerse-and-agitate elution and insert assay device
An assay method where a collected sample is placed on a sampling device, immersed and agitated in a developer solution vial to elute and recover the sample, and then the assay device is inserted into the developer solution to perform a diagnostic assay.
Across the independent claim and refinements, the coverage centers on a developer solution vial with an elongated housing and cavity, a mating portion that includes a rounded semi-circular extraction portion for recovery and elution, and a seating portion that mates with a collection pad resting surface to prevent compression while enabling elution from an inserted sampling device. Dependent claims further constrain developer solution and cavity volumes, specify extraction interface bottleneck geometry based on sampling device width, optionally require transparent material, and describe an assay workflow including immersing and agitating for elution followed by inserting the assay device.
Stated Advantages
Improves contact to reduce sample dilution and increase elution and wicking into a submerged collection pad.
Prevents compression of a sampling portion of the collection pad when in a resting position in the developer solution.
Documented Applications
Point-of-care lateral flow assay testing using a developer solution vial with sampling devices and assay devices, including respiratory disease testing.
COVID-19 antigen detection using a lateral flow assay, including SARS nucleocapsid antigen detection.
Assay workflows involving collecting a sample, immersing and agitating a sampling device in the developer solution vial to elute and recover the sample, and inserting an assay device to perform a diagnostic assay.
Alternative embodiments using integrated sampling devices or direct collection pads with the minimized vial and optionally no extraction portion.
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