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Publication Number
US-12145153-B2
Publication Date
2024-11-19
Expiration Date
Abstract
A lateral flow assay cassette comprising a swab holder is provided herein. Also provided are kits comprising the lateral flow assay cassette and methods of detecting an analyte.
Core Innovation
The disclosed invention relates to a lateral flow assay cassette that includes a sample pad and a sample port providing access to the sample pad, and a membrane housed in an outer housing having a fixed external result display window that provides visibility to the membrane. The cassette further includes a swab holder that secures a swab having a stem and a head, where protrusions secure the swab stem such that the swab head is in the sample port directly above the sample pad or directly in contact with the sample pad.
The invention solves problems in lateral flow testing by reducing user steps through cassette-integrated swab-to-sample-pad positioning, thereby avoiding a separate swab lysis tube and preserving analyte concentration. The disclosed approach supports direct placement of the swab head relative to the sample pad, followed by addition of lysis buffer to elute analyte onto the membrane, with the outer housing enabling a fixed external result window.
In the described implementations, the assay supports broad analyte and infectious-agent scope, including an immunoassay for SARS-CoV-2 antigen. Documented evaluation includes Limit of Detection (LoD) and positivity performance, and results are described in terms of cross-reactivity, microbial interference, endogenous interference substances, high-dose hook effect, and specimen stability, along with clinical performance metrics such as PPA and NPA and stability within defined room and refrigerated times.
Claims Coverage
The document contains three independent claim types covering (i) a lateral flow assay cassette structure with a swab holder that positions a swab head above or in contact with a sample pad, (ii) a method of detecting an analyte using that cassette with lysis buffer elution via lysis buffer dropper bottle drops, and (iii) a kit including the cassette plus a swab with a specified stem diameter and lysis buffer adapted to drop a set number of drops. The independent claims collectively emphasize the swab holder protrusions and the swab-head-to-sample-pad positioning, and they further specify lysis buffer handling and kit contents.
Direct positioning of swab head relative to sample pad
A lateral flow assay cassette comprising a sample pad; a sample port that allows access to the sample pad; a membrane; an outer housing comprising a fixed external result display window that provides visibility to the membrane; and a swab holder that secures a swab having a stem and a head, the swab holder comprising protrusions that secure the swab stem such that the swab head is in the sample port directly above the sample pad or directly in contact with the sample pad.
Lysis buffer elution from swab head into sample port and sample pad
A method of detecting an analyte comprising providing a lateral flow assay cassette having a sample pad, a sample port that allows access to the sample pad, a membrane, an outer housing comprising a fixed external result display window that provides visibility to the membrane, and a swab holder that secures a swab having a stem and a head, the swab holder comprising protrusions that secure the swab stem such that the swab head is in the sample port directly above the sample pad or directly in contact with the sample pad; collecting a sample from a subject using the swab; placing the swab stem into the swab holder such that the swab head is in the sample port directly above the sample pad or directly in contact with the sample pad; adding an appropriate amount of lysis buffer directly to the swab head after step c); and eluting the sample from the swab head with the lysis buffer directly into the sample port and the sample pad, wherein said elution is accomplished by adding one or more drops from a lysis buffer dropper bottle.
Kit configured with set-number drop lysis buffer and stem-sized swab
A kit comprising a lateral flow assay cassette comprising a sample pad; a sample port that allows access to the sample pad; a membrane; an outer housing comprising a fixed external result display window that provides visibility to the membrane; a swab holder that secures a swab having a stem and a head, the swab holder comprising protrusions that secure the swab stem such that the swab head is in the sample port directly above the sample pad or directly in contact with the sample pad; a swab having a stem with a diameter sized to be secured by the swab holder; and lysis buffer adapted for dropping a set number of drops of the lysis buffer on the swab head.
Across the independent claims, the core inventive structure is the swab holder protrusions that position the swab head directly above the sample pad or in direct contact with the sample pad through the sample port, combined with cassette visibility via a fixed external result display window. The independent method claim then uses this positioning to add lysis buffer directly to the swab head and elute the sample into the sample port and sample pad using drops from a lysis buffer dropper bottle. The independent kit claim additionally requires a stem-diameter-swab sized to be secured by the swab holder and lysis buffer adapted to drop a set number of drops onto the swab head.
Stated Advantages
Reduces user steps by avoiding a separate swab lysis tube.
Preserves analyte concentration.
Enables direct placement of the swab head onto or above a sample pad for lysis buffer addition and elution onto the membrane.
Documented Applications
Detecting an analyte using a lateral flow assay cassette for immunoassay of SARS-CoV-2 antigen, with clinical evaluation including PPA and NPA and analysis including LoD, cross-reactivity, microbial interference, endogenous interference substances, high-dose hook effect, and specimen stability.
Detecting an analyte to indicate the presence of an infectious agent in a subject, with applicability to broad infectious agents enumerated in the document.
Using the method with samples collected from specified human anatomical sites or body fluids, including nasal/nasopharyngeal and other cavity swabs, oral and other tissue sources, outer ear canal sources, skin/wound/lesion sources, genital and rectal sources, and various secretions and biological specimens.
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