Reader device for luminescent immunoassays

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 ( 104 a , 104 b ) and associated electronics configured to receive data from and control the optical system ( 121 ) and to control the electromechanical motor system ( 106 ).

We 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.   
     
     
         2 . The reader system of  claim 1 , further comprising non-volatile or volatile digital memory for storing data generated by the optical system. 
     
     
         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. 
     
     
         4 . The reader system of  claim 3 , wherein the data entry device comprises an integrated keypad or a touch-screen. 
     
     
         5 . The reader system of any one of the preceding claims, wherein the light source is a surface mounted light emitting diode. 
     
     
         6 . The reader system of  claim 5 , wherein the surface mounted light emitting diode comprises a collimation lens. 
     
     
         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. 
     
     
         8 . The reader system of  claim 7 , wherein emitted light is directed onto the central portion of a photodiode. 
     
     
         9 . The reader system of any one of the preceding claims, wherein the excitation optics further comprises an optical excitation filter. 
     
     
         10 . The reader system of  claim 9 , wherein the optical excitation filter is a band-pass or short-pass optical filter. 
     
     
         11 . The reader system of  claim 9 , wherein the optical excitation filter operates by interference or by absorption. 
     
     
         12 . The reader system of any one of the preceding claims, wherein the collection optics further comprises an optical collection filter. 
     
     
         13 . The reader system of  claim 12 , wherein the optical collection filter is mechanically actuated. 
     
     
         14 . The reader system of  claim 12 , wherein the optical collection filter is a band-pass or long-pass optical filter. 
     
     
         15 . The reader system of  claim 12 , wherein the optical collection filter operates by interference or by absorption. 
     
     
         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. 
     
     
         17 . The reader system of  claim 16 , wherein the plate is absorptive or reflective. 
     
     
         18 . 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. 
     
     
         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. 
     
     
         20 . The reader system of  claim 19 , wherein the vertically oriented immunoassay device comprises one or more immunoassay channels. 
     
     
         21 . 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. 
     
     
         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. 
     
     
         23 . 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. 
     
     
         24 . 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. 
     
     
         25 . The reader system of  claim 22 , wherein electronic frequency filtering is used to filter signals from the multiple photosensors. 
     
     
         26 . 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. 
     
     
         27 . The reader system of  claim 1 , wherein the excitation optics comprises a photosensor that monitors the light source. 
     
     
         28 . 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. 
     
     
         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. 
     
     
         30 . 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. 
     
     
         31 . 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. 
     
     
         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. 
     
     
         33 . 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. 
     
     
         34 . The reader system of any one of the preceding claims, further comprising at least one sensor for recognizing cartridge insertion or removal. 
     
     
         35 . The reader system of  claim 34 , wherein the sensor is an optical or mechanical sensor. 
     
     
         36 . The reader system of any one of the preceding claims, further comprising a barcode reading system. 
     
     
         37 . The reader system of  claim 36 , wherein the barcode reading system is one-dimensional or two-dimensional. 
     
     
         38 . 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. 
     
     
         39 . The reader system of  claim 1 , further comprising a physically separate quality control component with substantially the same external dimensions as a cartridge. 
     
     
         40 . 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. 
     
     
         41 . 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. 
     
     
         42 . 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. 
     
     
         43 . 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. 
     
     
         44 . 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. 
     
     
         45 . 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. 
     
     
         46 . 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. 
     
     
         47 . 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. 
     
     
         48 . 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. 
     
     
         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. 
     
     
         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. 
     
     
         51 . The reader system of  claim 50 , wherein the travel sensors are optical or mechanical. 
     
     
         52 . The reader system of any one of the preceding claims, further comprising a printer. 
     
     
         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. 
     
     
         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. 
     
     
         55 . The reader system of any one of the preceding claims, further comprising alignment features within the holster for ensuring alignment of the cartridge.