US2014057362A1PendingUtilityA1

Lateral flow assay analysis

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Assignee: MARKOVSKY ROBERT JPriority: Aug 26, 2010Filed: Aug 25, 2011Published: Feb 27, 2014
Est. expiryAug 26, 2030(~4.1 yrs left)· nominal 20-yr term from priority
G01N 21/8483G01N 2201/0627G01N 21/75G01N 21/78
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Claims

Abstract

Lateral flow assay analysis is shown and described. In one embodiment, the lateral flow assay comprises a surface having a reflectance profile that is adapted to enable monitoring of the assay continuously until the detection of an analyte. In other embodiments, a lateral flow assay system includes an incubator and a reader, wherein the incubator incubates the assay concurrently as the reader generates a test result. Further, an assay measurement apparatus may include an optical detector to perform continuous image detection of the assay to generate a diagnostic test result.

Claims

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         2 . An assay measurement apparatus to generate a diagnostic test result from an assay, said apparatus comprising:
 a. an optical detector aligned in an optical path with said assay, wherein said optical detector is adapted to acquire an image detection on said assay due to an aberration on said assay; and   b. a microprocessor in communication with said optical detector, wherein said microprocessor is adapted to signal said optical detector to perform continuous image detection of said assay to generate said diagnostic test result.   
     
     
         3 . The apparatus of  claim 2 , wherein said optical detector comprises a decoding sensor adapted to align with said assay and decode a reference coding on said assay. 
     
     
         4 . The apparatus of  claim 3 , wherein said reference coding activates a corresponding diagnostic test in said optical detector. 
     
     
         5 . The apparatus of  claim 3 , wherein said apparatus includes a multichannel reader and said reference coding activates a corresponding channel in said multichannel reader. 
     
     
         6 . The apparatus of  claim 5 , wherein said corresponding channel includes an associated feature chosen from a standard curve, a does-response curve, a positive cutoff value, a negative cutoff value and a combination thereof. 
     
     
         7 . The apparatus of  claim 3 , wherein said apparatus includes an incubator and said reference coding activates a corresponding incubation temperature. 
     
     
         8 . The apparatus of  claim 3 , wherein said decoding sensor is a color sensor. 
     
     
         9 . The apparatus of  claim 8 , wherein said color sensor is a photodiode with sensitivity to wavelengths chosen from red, blue, green and a combination thereof. 
     
     
         10 . The apparatus of  claim 3 , wherein said decoding sensor is reader chosen from an RFID reader, a bar code reader and a combination thereof. 
     
     
         11 . The apparatus of  claim 2 , including a light source. 
     
     
         12 . The apparatus of  claim 11 , wherein said light source is an array of discrete light sources. 
     
     
         13 . The apparatus of  claim 12 , wherein said discrete light sources comprise light emitting diodes. 
     
     
         14 . The apparatus of  claim 11  wherein said light emitting diodes are colored diodes chosen from red, green, blue and a combination thereof. 
     
     
         15 . The apparatus of  claim 11 , wherein said light source comprises an illumination profile suitable for reflecting on a test strip assay. 
     
     
         16 . The apparatus of  claim 11 , wherein said light source is aligned with a light aperture exposing said light source on said assay. 
     
     
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         22 . The apparatus of  claim 3 , wherein said optical detector will not generate a test result until said decoding sensor decodes said reference coding. 
     
     
         23 . The apparatus of  claim 2 , wherein said optical detector is a light-to-voltage sensor. 
     
     
         24 . The apparatus of  claim 2 , wherein said optical detector comprises a photodiode coupled to an integrated circuit in said optical path with said assay. 
     
     
         25 . The apparatus of  claim 24 , wherein said integrated circuit is a monolithic integrated circuit. 
     
     
         26 . The apparatus of  claim 2 , wherein said optical detector includes an amplifier. 
     
     
         27 . The apparatus of  claim 26 , wherein the amplifier is a translucence amplifier. 
     
     
         28 . The apparatus of  claim 2 , including a memory adapted to store information corresponding to an imaging parameter for said image detection. 
     
     
         29 . The apparatus of  claim 2 , including a decoding sensor chosen from a color sensor, a RFID reader, a bar code reader and a combination thereof. 
     
     
         30 . The apparatus of  claim 2 , wherein said optical detector includes an optical window adapted to block debris from contact with said optical detector. 
     
     
         31 . The apparatus of  claim 2 , wherein said optical detector includes an optics housing to enclose said optical detector and is adapted to block debris from contact with said optical detector. 
     
     
         32 . The apparatus of  claim 2 , wherein said optical detector monitors a diagnostic test progress. 
     
     
         33 . The apparatus of  claim 32 , wherein said optical detector monitors a pre-test parameter prior to generating a diagnostic test result. 
     
     
         34 . The apparatus of  claim 32 , wherein said optical detector monitors at least one pre-test parameter after said optical detector has acquired at least one image detection on said assay. 
     
     
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         102 . A method of detecting an analyte from an assay, the method comprising:
 a. aligning an optical detector in an optical path with said assay;   b. acquiring an image detection on said assay due to an aberration on said assay; and   c. signaling said optical detector to perform continuing image detection of said assay to generate said test result.   
     
     
         103 . The method of  claim 102 , wherein signaling said optical detector includes instructing said optical detector to monitor a pre-test analysis on said assay. 
     
     
         104 . The method of  claim 103 , wherein instructing said optical detector to monitor said pre-test analysis includes decoding a reference coding on said assay. 
     
     
         105 . The method of  claim 104 , including activating a corresponding channel in a multichannel reader. 
     
     
         106 . The method of  claim 104 , including activating an incubation of said assay. 
     
     
         107 . The method of  claim 102 , wherein signaling said optical detector includes instructing said optical detector to generate said test result. 
     
     
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         198 . A lateral flow assay system to generate a test result from an assay, said system comprising:
 a. an incubator adapted to incubate said assay; and   b. a reader adapted to read a diagnostic test on said assay that undergoes a change when contacted with a sample to generate said test result,   wherein said incubator incubates said assay concurrently as said reader generates said test result.   
     
     
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         221 . The apparatus of  claim 198 , wherein said reader performs continuous image detection of said assay to generate said test result. 
     
     
         222 . The apparatus of  claim 221 , wherein said continuous image detection includes monitoring a pre-flow development along said assay. 
     
     
         223 . The apparatus of  claim 198 , wherein said reader includes a light source oriented in a predetermined pattern with respect to said assay. 
     
     
         224 . The apparatus of  claim 223 , wherein said light source includes a first mirror below said light source. 
     
     
         225 . The apparatus of  claim 224 , wherein said light source includes a focusing lens adapted to receive light from said first mirror. 
     
     
         226 . The apparatus of  claim 225 , wherein said light source includes a second mirror positioned to direct light from the focusing lens to said reader. 
     
     
         227 . The apparatus of  claim 198 , wherein said reader includes a sensor. 
     
     
         228 . The apparatus of  claim 227 , wherein said sensor is an optical detector aligned with a light source for detecting transmission of light through said assay. 
     
     
         229 . The apparatus of  claim 227 , wherein said sensor is a decoding sensor. 
     
     
         230 . The apparatus of  claim 229 , wherein said decoding sensor adapted to decode at least one reference code having a corresponding testing sequence on said assay. 
     
     
         231 . The apparatus of  claim 198 , wherein said reader includes multiple channels. 
     
     
         232 . The apparatus of  claim 231 , wherein each said channel includes an associated feature chosen from a standard curve, a does-response curve, a positive cutoff value, a negative cutoff value and a combination thereof. 
     
     
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