Point-of-care diagnostic cartridge having a lateral flow assaying apparatus

Inventors

Carrano, John Jacob • Carrano, John

Assignees

Paratus Diagnostics LLC

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Publication Number

US-10583435-B1

Patent

Publication Date

2020-03-10

Expiration Date


Abstract

A specimen processing cartridge includes a reservoir having a fluid inlet, an elastic diaphragm, and a fluid outlet. The reservoir is operable to receive a volume of liquid from the fluid inlet, and the fluid outlet is positioned along a fluid flow path between the reservoir and a downstream reservoir. The cartridge includes a dissolvable membrane that occludes flow through the fluid outlet when the dissolvable membrane is in a first, undissolved state, and that permits flow from the reservoir to the downstream reservoir when in a second, dissolved state. The elastic diaphragm is operable to pressurize the reservoir upon receiving the volume of liquid when the dissolvable membrane is in the first, undissolved state, and is operable to contract and propel at least a portion of the volume of liquid from the reservoir to the downstream reservoir when the dissolvable membrane is in the second, dissolved state.

Core Innovation

A point-of-care specimen processing cartridge enables timed sequencing and downstream analysis by metering and sequencing liquids using dissolvable membranes and an elastic diaphragm. In an undissolved state, a dissolvable membrane occludes a fluid outlet so that liquid remains prevented from flowing to a downstream reservoir. After a predetermined time, the membrane dissolves to enable diaphragm contraction/expansion that propels timed liquids from an intermediate reservoir to a downstream reservoir.

The downstream flow wicks through a viewing area and incorporates a lateral flow assaying apparatus formed by offset hydrophilic plates. The offset plates define a capillary channel with a detection zone in which at least one detection locus is positioned within the capillary channel. The detection zone can be associated with a lens array aligned to a detection-locus arrangement so that light directed to the capillary channel is arranged for detection.

The detection zone uses chemiluminescence detection arrangements with luminol/H2O2 reagent timing and can include receptor-functionalized detection loci. A capillary plate can include optional metalized or reflective surfaces to direct light toward detection loci, with biological receptors at the detection locus such as antibody-based capture. Readout can be performed using a smartphone/camera via a mating adaptor for detection.

Claims Coverage

The independent claims cover three inventive features: a lateral flow assaying apparatus with offset plates and a capillary channel, a method of detecting a target based on luminescence at a detection zone, and a specimen processing cartridge incorporating the same lateral flow assaying apparatus.

Offset-plate capillary channel with detection zone

A lateral flow assaying apparatus comprising a first plate having a viewing surface and an inner surface, a second plate offset from the first plate and comprising a channel-facing surface, a capillary channel bounded by the inner surface of the first plate and the channel-facing surface of the second plate, and a detection zone comprising at least one detection locus positioned within the capillary channel.

Luminescence-based target determination in a detection zone

A method for detecting a target using a lateral flow assaying apparatus comprising delivering a first liquid from a first fluid source to a capillary channel of the lateral flow assaying apparatus, the first liquid including a biological sample, analyzing at least one location of a detection zone, and determining whether the target is present based on a luminescence of the at least one location of the detection zone.

Specimen processing cartridge incorporating the offset-plate lateral flow assaying apparatus

A specimen processing cartridge having a lateral flow assaying apparatus comprising a first plate having a viewing surface and an inner surface, a second plate offset from the first plate and comprising a channel-facing surface and an opposing backing surface, a capillary channel bounded by the inner surface of the first plate and the channel-facing surface of the second plate, and a detection zone comprising at least one detection locus positioned within the capillary channel.

Overall, the independent claims define an offset-plate lateral flow assaying apparatus in which a capillary channel is bounded by an inner surface of a first plate and a channel-facing surface of an offset second plate, with a detection zone containing at least one detection locus positioned within the capillary channel. The method claim adds luminescence-based detection of whether a target is present at locations of the detection zone using liquids delivered to the capillary channel, and the specimen processing cartridge claim incorporates the lateral flow assaying apparatus into a specimen processing cartridge.

Stated Advantages

Documented Applications

No documented applications found

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