# US 11,442,012 B2 · Assay device employing fluorescent labels

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- Number: US 11,442,012 B2
- Document ID: US11442012B2
- Status: Granted
- Kind: B2
- Application number: 16/779,025
- Filed: 2020-01-31
- Published: 2020-05-28
- Granted: 2022-09-13
- Earliest claimed: 2013-06-19
- Assignees: Ellume Limited
- Applicants: Ellume Limited
- Inventors: Sean Andrew Parsons; Michael Stuart Hazell; David Lara
- Web page: https://patentgrep.com/patent/US11442012B2

## CPC

- G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)}
- G01N 21/255: {Details, e.g. use of specially adapted sources, lighting or optical systems}
- G01N 21/645: {Specially adapted constructive features of fluorimeters}
- G01N 21/8483: {Investigating reagent band (test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04)}
- G01N 33/4875: {Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method (test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B)}
- G02B 6/42: Coupling light guides with opto-electronic elements
- G02B 7/02: for lenses {(supports for magnifying lenses G02B25/002)}
- G01N 2021/6439: {with indicators, stains, dyes, tags, labels, marks}
- G01N 2021/6463: {Optics}
- G01N 2021/6465: {Angular discrimination}
- G01N 2021/6478: {Special lenses}
- G01N 2021/6484: {Optical fibres}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS

## Abstract

An assay device is disclosed comprising a housing and a test portion, electronic circuitry and an optical assembly each a least partially located in the housing. The test portion comprises one or more test zones adapted to receive an analyte and a fluorescent label associated with the analyte, the fluorescent label being excitable by excitation light and adapted to emit emission light upon excitation by excitation light. The electronic circuitry comprises one or more light sources and one or more light detectors. The optical assembly comprises one or more excitation light guides adapted to guide excitation light from the one or more light sources to the one or more test zones, and/or one or more emission light guides adapted to guide emission light from the one or more test zone to the one or more light detectors.

## Claims

### Claim 1

An assay device comprising:
a housing; and
a test portion, electronic circuitry and an optical assembly, each a least partially located in the housing; wherein:
the test portion comprises at least one test zone;
the electronic circuitry comprises at least one light source and at least one light detector; and
the optical assembly comprises at least one light guide adapted to guide light from the at least one light source to the at least one test zone;
wherein the at least one light guide comprises a first end and a second end opposite to the first end, and the at least one light guide further comprises:
a convex light collimator lens provided at a first end face, the first end face being located at the first end of the at least one light guide and comprising a first edge and a second edge opposite to the first edge; and
a light focussing reflector face and a light exit face, the light focussing reflector face joined to the first edge of the first end face and extending from the first edge towards the second end of the at least one light guide, and the light exit face joined to the second edge of the first end face and extending from the second edge towards the second end of the at least one light guide, the light focussing reflector face and the light exit face converging towards each other as they extend towards the second end of the at least one light guide,
wherein the at least one light guide is configured such that at least a portion of light from the at least one light source enters the at least one light guide through the collimator lens, reflects off the light focussing reflector face and exits the at least one light guide through the light exit face to travel to the test zone,
wherein the at least one light detector is configured to receive light emanating from the at least one test zone.

### Claim 2 (depends on 1)

The assay device of claim 1, wherein the light reflector face is curved.

### Claim 3 (depends on 1)

The assay device of claim 1, wherein the light exit face is flat.

### Claim 4 (depends on 1)

The assay device of claim 1, wherein the test portion is a test strip having an axis of elongation.

### Claim 5 (depends on 4)

The assay device of claim 4, wherein the light exit face is positioned perpendicularly to the axis of elongation.

### Claim 6 (depends on 4)

The assay device of claim 4, wherein the light reflector face is positioned at an angle relative to the axis of elongation.

### Claim 7 (depends on 1)

The assay device of claim 1, wherein the at least one light guide has a wedge-shape.

### Claim 8 (depends on 1)

The assay device of claim 1, wherein a best fit plane extending through the light focussing reflector surface is at an angle to a plane of the light exit face of between 30 and 50 degrees.

### Claim 9 (depends on 1)

The assay device of claim 1, wherein a best fit plane extending through the reflector surface is at an angle to a plane of the light exit face of about 40 degrees.

### Claim 10 (depends on 1)

The assay device of claim 1, wherein the light focussing reflector face and the light exit face converge towards the second end of the at least one light guide to form a tip at the second end of the at least one light guide, wherein light does not exit the at least one light guide through the tip to travel to the at least one test zone.

### Claim 11 (depends on 1)

The assay device of claim 1, wherein the light focussing reflector face provides a combined mirror and lens to reflect and provide optical power to light passing through the at least one light guide to the at least one test zone.

### Claim 12 (depends on 1)

The assay device of claim 1, wherein the light focussing reflector face is configured such that at least a portion of light reflected off of the light focussing reflector face, is total internal reflection.
