Strip for lateral flow assay, comprising subpad, and cartridge for lateral flow assay used for the same

Inventors

Kim, Byeong ChulPark, Ki TaeKim, Hyun Jeong

Assignees

Boditech Med Inc

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Publication Number

US-9393563-B2

Patent

Publication Date

2016-07-19

Expiration Date


Abstract

The present application relates to: a strip for lateral flow assay, comprising a support, a medium for development, a sample pad comprising a subpad, and an absorption pad; and a cartridge for lateral flow assay, comprising the same. According to the present application, the strip adopts a novel sample loading method, thereby obtaining reproducible results irrespective of the volume of an injected sample, and it is possible to readily change the amount of a sample, as necessary, thereby improving the reproducibility of measured results and convenience.

Core Innovation

A lateral flow assay cartridge is provided that accommodates a strip. The cartridge includes a base member that has a strip receiving part accommodating the strip and a sample receiving well extended from the strip receiving part at one end of the base member, and a cover member that covers the base member and includes a sample inlet and a measurement window, where the sample receiving well is formed at a position corresponding to the sample inlet when the cover member covers the base member.

The lateral flow assay strip is arranged on a solid support with a chromatographic medium, a sample pad having a subpad with a body portion, a slant extended from the body portion, and a dipping portion extended from the slant, and an absorption pad. The chromatographic medium is positioned on the solid support between a first end adjacent to one end of the sample pad and a second end adjacent to one end of the absorption pad, with the sample pad and absorption pad arranged at opposite ends of the solid support.

The cover member further includes three guides formed at a second position, a third position and a fourth position inside the cover member facing the strip. The second position corresponds to an area where a boundary of the slant and the body portion of the subpad is located when the cover member covers the base member, the third position corresponds to an area where a boundary of the sample pad and the body portion of the subpad is located, and the fourth position corresponds to an area where a boundary of the sample pad and the chromatographic medium is located.

The cartridge and strip interaction via the sample receiving well, sample inlet, and the structured subpad and guides are described as enabling sample loading and capillary action through the chromatographic medium and absorption pad with improved reproducibility across variations in sample volume. From the background, the problem addressed is improving reproducibility and convenience in a lateral flow assay when sample volume varies, including avoiding issues such as pipetting errors.

Claims Coverage

The partial content provides one independent claim and dependent refinements. The inventive features concentrate on the cartridge architecture, the specific strip subpad geometry, and alignment and flow control using multiple internal guides located at defined positions corresponding to boundaries within the strip.

Cartridge with aligned sample receiving well and cover defining sample inlet and measurement window

A cartridge has a base member with a strip receiving part and a sample receiving well at one end, and a cover member that covers the base member and includes a sample inlet and a measurement window, wherein the sample receiving well is positioned to correspond to the sample inlet when the cover member covers the base member.

Strip layout with solid support, chromatographic medium, sample pad subpad, and absorption pad

The strip comprises a solid support, a chromatographic medium, a sample pad with a subpad having a body portion, a slant extended from the body portion and a dipping portion extended from the slant, and an absorption pad; the chromatographic medium, the sample pad and the absorption pad are positioned on the solid support with one end of the chromatographic medium adjacent to one end of the sample pad and the other end of the chromatographic medium adjacent to one end of the absorption pad.

Three internal guides positioned to correspond to strip boundaries

The cover member comprises three guides formed at a second position, a third position and a fourth position inside the cover member facing the strip, where the second position corresponds to an area where a boundary of the slant and the body portion of the subpad is located, the third position corresponds to an area where a boundary of the sample pad and the body portion of the subpad is located, and the fourth position corresponds to an area where a boundary of the sample pad and the chromatographic medium is located when the cover member covers the base member.

Guides shaped as a dam or a protrusion

The cartridge further characterizes the three guides as being formed in a shape of a dam or as a protrusion.

Ventilation window in the cover between the sample inlet and measurement window

The cover member includes a ventilation window positioned between the sample inlet and the measurement window.

Measurement-window cover configured to open or close

A cartridge includes a cover configured to open or close a measurement window.

Across the independent claim and its dependent refinements, the claim coverage emphasizes a lateral flow assay cartridge that aligns a sample inlet with a sample receiving well, uses a strip with a sample pad subpad having a body portion, slant, and dipping portion, and positions three internal guides in the cover at locations corresponding to boundaries within the strip to manage capillary flow through the chromatographic medium and absorption pad.

Stated Advantages

Improves reproducibility across variations in sample volume.

Improves convenience in changing sample amount without changing the cartridge.

Helps reduce problems such as pipetting errors.

Documented Applications

Not explicitly described in patent.

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