Medical Diagnostic System and Method

Abstract

A medical diagnostic system is provided to automate analysis of samples to predict a medical condition, such as pregnancy or chronic kidney disease. The system may provide test strip usage automation. The medical diagnostic system may include a sample collection component, collection cup contamination protection mechanism, sample volume control component, test strip reader component, which may be manifested as a lateral flow strip reader, flow reader, sample analytic component, data processing component, data communication component, networked data management component, and device cleaning mechanism. A method to automate analysis of samples to predict a medical condition using the medical diagnostic system is also provided.

What is claimed: 
     
         1 . A system comprising:
 a test strip configured to indicate a condition of a patient when exposed to a sample from the patient;   a sensor configured to capture a color image of the test strip exposed to the sample, wherein the color image indicates the condition of the patient; and   a computing device configured to analyze the color image of the test strip captured by the sensor in order to determine the condition of the patient, wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient comprises:
 opening the color image; 
 cropping the color image; 
 converting the color image to a grayscale image; 
 calculating a sum of each row based on the grayscale image; 
 identify a control line location corresponding to the grayscale image, wherein the control line location corresponds to a row having a local minimum average pixel value or a local maximum average pixel value across the grayscale image; 
 identify a test line location corresponding to the grayscale image, wherein the test line location is based on a relative distance to the control line location within the grayscale image; 
 determine whether a control line is present in the control line location; 
 determine whether a test line is present in the test line location; and 
 report a result based on whether the control line is present in the control line location and whether the test line is present in the test line location. 
   
     
     
         2 . The system of  claim 1 , wherein reporting the test result comprises:
 reporting an error when the control line is not present in the control line location;   reporting a negative test result when the control line is present in the control line location and the test line is not present in the test line location; and   reporting a positive test result when the control line is present in the control line location and the test line is present in the test line location.   
     
     
         3 . The system of  claim 1 , further comprising an electronically-stored medium,
 wherein the electronically-stored medium is configured to store the determined condition of the patient,   wherein the computing device is configured to transmit the determined condition of the patient to an additional electronically-stored medium for inclusion in an electronic health record of the patient,   wherein the electronic health record of the patient contains additional health data relating to the patient, and   wherein the additional data relating to the patient comprises at least one of a unique patient identifier, a result of the test strip, or an image of the test strip.   
     
     
         4 . The system of  claim 1 , wherein the relative distance to the control line location is determined based on a set number of pixels. 
     
     
         5 . The system of  claim 1 , further comprising a scanner configured to detect an identification of the patient,
 wherein the scanner comprises a barcode scanner or a radio-frequency identification (RFID) scanner,   wherein, upon the scanner detecting the identification of the patient, the system is configured to collect, process, and analyze the sample in an automated fashion, and   wherein the computing device is configured to transmit the condition of the patient to an electronically-stored medium for inclusion in an electronic health record of the patient based on the identification of the patient.   
     
     
         6 . The system of  claim 1 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises applying a filter to reduce noise or increase signal in the color image or the grayscale image. 
     
     
         7 . The system of  claim 6 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises applying a threshold to further reduce noise in the color image or the grayscale image. 
     
     
         8 . The system of  claim 7 , wherein the threshold comprises an adaptive Gaussian threshold. 
     
     
         9 . The system of  claim 1 , wherein the color image is a red-green-blue (RGB) picture of the test strip, and wherein cropping the color image comprises cropping the color image to boundaries of the test strip within the color image. 
     
     
         10 . The system of  claim 1 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises converting from the grayscale image to a binary image by setting a threshold. 
     
     
         11 . The system of  claim 10 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises performing morphological operations to fill any holes in the binary image. 
     
     
         12 . The system of  claim 11 , wherein performing the morphological operations comprises:
 defining a kernel size;   performing an open operation with the kernel; and/or   performing a close operation with the kernel.   
     
     
         13 . The system of  claim 10 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises performing a Laplacian gradient on the binary image. 
     
     
         14 . The system of  claim 1 , wherein analyzing the color image of the test strip captured by the sensor in order to determine the condition of the patient further comprises:
 setting a threshold; and   counting a number of peaks across the test strip in the color image or the grayscale image based on the threshold.   
     
     
         15 . The system of  claim 1 ,
 wherein the tests strip comprises aptamers, antibodies, chemical reagents, biomolecules, or a substance that binds or reacts to the sample,   wherein the test strip is specifically used to indicate a predetermined condition, and   wherein the predetermined condition comprises chronic kidney disease (CKD), glucose levels, opiate levels, albumin to creatinine ratio, human chorionic gonadotropin (hCG) levels, specific gravity, pH levels, protein levels, ketone levels, bilirubin levels, nitrite levels, or leukocytes levels.   
     
     
         16 . The system of  claim 1 ,
 wherein the test strip is one of a plurality of test strips,   wherein the plurality of test strips is housed in a replaceable cartridge,   wherein multiple replaceable cartridges are inserted side-by-side,   wherein the plurality of test strips is stacked vertically in the replaceable cartridge with an opening at a bottom of the stack,   wherein the test strip is pushed onto a platform using a motor-operated pin,   wherein the platform is moved laterally, using a motor, to a predetermined position where the test strip is exposed to the sample from the patient,   wherein the platform is moved laterally, using the motor, to a position where the image of the test strip is captured by the sensor, and   wherein the platform is moved laterally, using the motor, to a position where the test strip is pushed off of the platform using a motor-operated pin into a waste bin to dispose of the test strip.   
     
     
         17 . The system of  claim 1 ,
 wherein the sensor comprises a complementary metal-oxide-semiconductor (CMOS) sensor and a light excitation source, and   wherein the captured image of the test strip comprises a light intensity profile of the test strip.   
     
     
         18 . The system of  claim 1 ,
 wherein converting the color image to a grayscale image comprises converting the color image to a hue-saturation-value (HSV) color space, hue-saturation-lightness (HSL) color space, YUV color space, or YCbCr color space.   
     
     
         19 . A method comprising:
 exposing a test strip to a sample from a patient, wherein the test strip is configured to indicate a condition of the patient when exposed to the sample;   capturing a color image of the test strip using a sensor, wherein the color image indicates the condition of the patient; and   analyzing, by a computing device, the color image of the test strip in order to determine the condition of the patient, wherein analyzing the color image of the test strip in order to determine the condition of the patient comprises:
 opening the color image; 
 cropping the color image; 
 converting the color image to a grayscale image; 
 calculating a sum of each row based on the grayscale image; 
 identify a control line location corresponding to the grayscale image, wherein the control line location corresponds to a row having a local minimum average pixel value or a local maximum average pixel value across the grayscale image; 
 identify a test line location corresponding to the grayscale image, wherein the test line location is based on a relative distance to the control line location within the grayscale image; 
 determine whether a control line is present in the control line location; 
 determine whether a test line is present in the test line location; and 
 report a result based on whether the control line is present in the control line location and whether the test line is present in the test line location. 
   
     
     
         20 . A computing device configured to:
 receiving a color image of a test strip, wherein the test strip was exposed to a sample from a patient, wherein the test strip is configured to indicate a condition of the patient when exposed to the sample, wherein the color image of the test strip was captured using a sensor, and wherein the color image indicates the condition of the patient; and   analyzing, by a computing device, the color image of the test strip in order to determine the condition of the patient, wherein analyzing the color image of the test strip in order to determine the condition of the patient comprises:
 opening the color image; 
 cropping the color image; 
 converting the color image to a grayscale image; 
 calculating a sum of each row based on the grayscale image; 
 identify a control line location corresponding to the grayscale image, wherein the control line location corresponds to a row having a minimum average pixel value or a maximum average pixel value across the grayscale image; 
 identify a test line location corresponding to the grayscale image, wherein the test line location is based on a relative distance to the control line location within the grayscale image; 
 determine whether a control line is present in the control line location; 
 determine whether a test line is present in the test line location; and 
 report a result based on whether the control line is present in the control line location and whether the test line is present in the test line location.