# US 2014/0154792 A1 · Reader device for luminescent immunoassays

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- Number: US 2014/0154792 A1
- Document ID: US20140154792A1
- Status: Published application
- Kind: A1
- Application number: 14/234,136
- Filed: 2012-07-20
- Published: 2014-06-05
- Earliest claimed: 2011-07-22
- Assignees: Biosensia Patents Limited
- Applicants: Biosensia Patents Limited
- Inventors: Shane Moynihan; Diarmuid Flavin
- Web page: https://patentgrep.com/patent/US20140154792A1

## CPC

- G01N 21/6486: {Measuring fluorescence of biological material, e.g. DNA, RNA, cells (G01N21/6428 takes precedence)}
- 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 21/645: {Specially adapted constructive features of fluorimeters}
- G01N 21/6454: {using an integrated detector array}
- G01N 21/6456: {Spatial resolved fluorescence measurements; Imaging}
- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- G01N 33/5304: {Reaction vessels, e.g. agglutination plates (for solid-phase systems G01N33/543)}
- G01N 21/278: {Constitution of standards}
- G01N 21/6452: {Individual samples arranged in a regular 2D-array, e.g. multiwell plates}
- G01N 2021/6419: {Excitation at two or more wavelengths}
- G01N 2021/6421: {Measuring at two or more wavelengths}
- G01N 2021/6441: {with two or more labels}
- G01N 2021/6471: {Special filters, filter wheel}
- G01N 2021/7786: {Fluorescence}
- G01N 2201/0624: Compensating variation in output of LED source
- G01N 2201/0627: Use of several LED's for spectral resolution
- G01N 2201/0648: Shutters
- G01N 2201/0693: Battery powered circuitry
- 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)

## Abstract

The present disclosure, among other things, describes a reader system for analyzing one or more analytes in a fluid sample, comprising a casing (204) with at least one port (201) leading to a holster (301) which is configured to receive a cartridge (107) comprising a vertically oriented immunoassay device for analyzing one or more analytes in a fluid sample, an optical system (121) with excitation optics comprising a light source (302) and an excitation lens (305) configured to transmit light from the light source (302) and thereby excite a region of the vertically oriented immunoassay device when a cartridge (107) is placed in the holster (301), and collection optics comprising a photosensor (306) and a collection lens (307) configured to collect emitted light from the vertically oriented immunoassay device when a cartridge (107) is placed in the holster (301), an electromechanical motor system (106) configured to move the holster (301) in a vertical direction with respect to the optical system (121) so that the optical system (121) can interrogate different regions of the vertically oriented immunoassay device when a cartridge (107) is placed in the holster (301), and one or more digital processors (104a, 104b) and associated electronics configured to receive data from and control the optical system (121) and to control the electromechanical motor system (106).

## Claims

### Claim 1

A reader system for analyzing one or more analytes in a fluid sample, comprising:
a. a casing with at least one port leading to a holster which is configured to receive a cartridge comprising a vertically oriented immunoassay device for analyzing one or more analytes in a fluid sample;
b. an optical system with excitation optics comprising a light source and an excitation lens configured to transmit light from the light source and thereby excite a region of the vertically oriented immunoassay device when a cartridge is placed in the holster, and collection optics comprising a photosensor and a collection lens configured to collect emitted light from the vertically oriented immunoassay device when a cartridge is placed in the holster;
c. an electromechanical motor system configured to move the holster in a vertical direction with respect to the optical system so that the optical system can interrogate different regions of the vertically oriented immunoassay device when a cartridge is placed in the holster; and
d. one or more digital processors and associated electronics configured to receive data from and control the optical system and to control the electromechanical motor system.

### Claim 2 (depends on 1)

The reader system of claim 1, further comprising non-volatile or volatile digital memory for storing data generated by the optical system.

### Claim 3

The reader system of any one of the preceding claims, wherein the casing further comprises a display screen, a data entry device, or a combination thereof.

### Claim 4 (depends on 3)

The reader system of claim 3, wherein the data entry device comprises an integrated keypad or a touch-screen.

### Claim 5

The reader system of any one of the preceding claims, wherein the light source is a surface mounted light emitting diode.

### Claim 6 (depends on 5)

The reader system of claim 5, wherein the surface mounted light emitting diode comprises a collimation lens.

### Claim 7

The reader system of any one of the preceding claims, wherein the collection lens is configured to collect emitted light from an entire excited region.

### Claim 8 (depends on 7)

The reader system of claim 7, wherein emitted light is directed onto the central portion of a photodiode.

### Claim 9

The reader system of any one of the preceding claims, wherein the excitation optics further comprises an optical excitation filter.

### Claim 10 (depends on 9)

The reader system of claim 9, wherein the optical excitation filter is a band-pass or short-pass optical filter.

### Claim 11 (depends on 9)

The reader system of claim 9, wherein the optical excitation filter operates by interference or by absorption.

### Claim 12

The reader system of any one of the preceding claims, wherein the collection optics further comprises an optical collection filter.

### Claim 13 (depends on 12)

The reader system of claim 12, wherein the optical collection filter is mechanically actuated.

### Claim 14 (depends on 12)

The reader system of claim 12, wherein the optical collection filter is a band-pass or long-pass optical filter.

### Claim 15 (depends on 12)

The reader system of claim 12, wherein the optical collection filter operates by interference or by absorption.

### Claim 16

The reader system of any one of the preceding claims, wherein the excitation optics further comprises a plate with one or more optical apertures.

### Claim 17 (depends on 16)

The reader system of claim 16, wherein the plate is absorptive or reflective.

### Claim 18 (depends on 16)

The reader system of claim 16, wherein at least one dimension of the one or more apertures is in a range of 0.1-2 mm, 0.7-0.8 mm, or 0.3-0.4 mm.

### Claim 19

The reader system of any one of the preceding claims, wherein a cartridge comprising a vertically oriented immunoassay device is located within the holster.

### Claim 20 (depends on 19)

The reader system of claim 19, wherein the vertically oriented immunoassay device comprises one or more immunoassay channels.

### Claim 21 (depends on 20)

The reader system of claim 20, wherein the one or more immunoassay channels each independently comprise one or more test lines for analyzing one or more analytes.

### Claim 22

The reader system of any one of the preceding claims, wherein the vertically oriented immunoassay device comprises multiple immunoassay channels and the excitation optics comprises multiple light sources, each with different central wavelengths.

### Claim 23 (depends on 22)

The reader system of claim 22, wherein the collection optics comprises multiple photosensors, and the light sources and photosensors are configured in pairs so that they transmit light to and collect emitted light from different immunoassay channels.

### Claim 24 (depends on 22)

The reader system of claim 22, wherein the pairs of light sources and photosensors are configured so that different immunoassay channels are interrogated at different points in time.

### Claim 25 (depends on 22)

The reader system of claim 22, wherein electronic frequency filtering is used to filter signals from the multiple photosensors.

### Claim 26 (depends on 22)

The reader system of claim 22, wherein the multiple immunoassay channels are spatially separated such that cross talk between different immunoassay channels and different photosensors is substantially absent when the multiple immunoassay channels are interrogated simultaneously.

### Claim 27 (depends on 1)

The reader system of claim 1, wherein the excitation optics comprises a photosensor that monitors the light source.

### Claim 28 (depends on 27)

The reader system of claim 27, wherein measurements from the photosensor that monitors the light source are used to control the emission intensity of the light source.

### Claim 29

The reader system of any one of the preceding claims, wherein the optical collection plane of the collection optics and the optical excitation plane of the excitation optics form an angle that is offset from normal.

### Claim 30 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)

The reader system of any one of claims 19-29, wherein the one or more digital processors collect data generated when the optical system scans the vertically oriented immunoassay device.

### Claim 31 (depends on 30)

The reader system of claim 30, wherein the one or more digital processors process the data to quantify an amount of one or more analytes in a fluid sample that was applied to the immunoassay device before the cartridge was placed in the holster.

### Claim 32

The reader system of any one of the preceding claims, further comprising one or more quality controls checks that are actualised in software on the one or more digital processors.

### Claim 33 (depends on 32)

The reader system of claim 32, wherein the one or more quality control checks are selected from the group consisting of checks of control line development, checks of channel clearance, checks as to the size and position of peaks, checks as to the time of an assay run as compared to expiry data of the immunoassay device, and any combination thereof.

### Claim 34

The reader system of any one of the preceding claims, further comprising at least one sensor for recognizing cartridge insertion or removal.

### Claim 35 (depends on 34)

The reader system of claim 34, wherein the sensor is an optical or mechanical sensor.

### Claim 36

The reader system of any one of the preceding claims, further comprising a barcode reading system.

### Claim 37 (depends on 36)

The reader system of claim 36, wherein the barcode reading system is one-dimensional or two-dimensional.

### Claim 38 (depends on 37)

The reader system of claim 37, wherein the two-dimensional barcode reading system encodes information selected from the group consisting of identification of cartridge type or lot data, lot manufacture and expiry dates, analyte names, cartridge expected response, lot parameters, peak finding parameters, calibration parameters, and any combination thereof.

### Claim 39 (depends on 1)

The reader system of claim 1, further comprising a physically separate quality control component with substantially the same external dimensions as a cartridge.

### Claim 40 (depends on 39)

The reader system of claim 39, wherein the quality control component comprises photoluminescent materials that exhibit characterised levels of photoluminescence upon excitation by the light source.

### Claim 41 (depends on 40)

The reader system of claim 40, wherein the photoluminescent materials are or comprise plastics impregnated with photoluminescent dyes, nanocrystals, quantum dots or any combination thereof.

### Claim 42 (depends on 40)

The reader system of claim 40, wherein photoluminescent areas are defined on the quality control component using masked materials, coated materials, multilayer etched materials or any combination thereof.

### Claim 43 (depends on 42)

The reader system of claim 42, wherein the photoluminescent areas are localised at the optical excitation plane of the excitation optics within the reader system when the quality control component is placed in the holster.

### Claim 44 (depends on 42)

The reader system of claim 42, wherein the photoluminescent areas are patterned such that optical misalignments within the reader system lead to predictable changes in the pattern or intensity of emitted light.

### Claim 45 (depends on 44)

The reader system of claim 44, wherein the one or more digital processors collect data generated when the optical system scans the quality control component and use the data to validate the reader system for further use.

### Claim 46 (depends on 44)

The reader system of claim 44, wherein the one or more digital processors collect data generated when the optical system scans the quality control component and use the data to modify internal calibration factors of the reader system.

### Claim 47 (depends on 44)

The reader system of claim 44, wherein the one or more digital processors collect data generated when the optical system scans the quality control component and use the data to calculate a degree of optical misalignment between the optical system and the holster.

### Claim 48 (depends on 47)

The reader system of claim 47, wherein the one or more digital processors control the electromechanical motor system to actuate and thereby bring the optical system and the holster into optical alignment.

### Claim 49

The reader system of any one of the preceding claims, wherein the electromechanical motor system comprises an encoder which is used to detect and report a relative position of the holster.

### Claim 50

The reader system of any one of the preceding claims, wherein the reader system comprises travel sensors that are used to detect and report a relative position of the holster.

### Claim 51 (depends on 50)

The reader system of claim 50, wherein the travel sensors are optical or mechanical.

### Claim 52

The reader system of any one of the preceding claims, further comprising a printer.

### Claim 53

The reader system of any one of the preceding claims, further comprising components and protocols for external wireless access, such as by Wi-Fi, ANT or Bluetooth.

### Claim 54

The reader system of any one of the preceding claims, further comprising components and protocols for wired connectivity, such as by serial, USB or Ethernet cable.

### Claim 55

The reader system of any one of the preceding claims, further comprising alignment features within the holster for ensuring alignment of the cartridge.