System and apparatus for point-of-care diagnostics

Abstract

A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

It is claimed: 
     
         1 . A system, comprising:
 an apparatus comprised of   (i) a housing configured to receive a test device, wherein the test device comprises a reference line and an analyte-specific test line;   (ii) an illumination source;   (iii) a detector; and   (iv) a processor comprising a software program for control of the illumination source and the detector;   wherein signal data obtained by the detector in response to illumination of the test device by the illumination source is processed to:   (a) generate a one-dimensional data array of values corresponding to signal data associated with the reference line and the analyte-specific test line,   (b) evaluate data in the data array corresponding to signal data from the reference line, and   (c) analyze signal data that corresponds to the analyte-specific test line to report a result regarding presence or absence of an analyte at the analyte-specific test line.   
     
     
         2 . The system of  claim 1 , wherein the detector comprises a photodetector. 
     
     
         3 . The system of  claim 1 , wherein the processor comprises a software program configured to direct analysis of data in the data array by calculating a first derivative of the data array to identify a minimum peak and a maximum peak corresponding to the reference line. 
     
     
         4 . The system of  claim 1 , wherein the processor comprises a software program configured to direct analysis of data in the data array by calculating a first derivative of the data array to form a derivative data set, wherein a positive peak and a negative peak in the derivative data set indicate location of the reference line on the test device. 
     
     
         5 . The system of  claim 1 , wherein the illumination source is a light emitting diode. 
     
     
         6 . The system of  claim 5 , wherein the light emitting diode emits light at about 365 nm. 
     
     
         7 . The system of  claim 1 , wherein the detector detects signal emitted from the test device during illumination by the illumination source. 
     
     
         8 . The system of  claim 7 , wherein the emitted signal is emitted from a fluorescing lanthanide compound. 
     
     
         9 . The system of  claim 8 , wherein the fluorescing lanthanide compound is chelated europium. 
     
     
         10 . The system of  claim 9 , wherein the chelated europium is embedded in microparticles. 
     
     
         11 . A method for analyzing a test line and reference line of a test device, comprising:
 inserting a test device comprising a reference line and an analyte-specific test line into an apparatus comprising an illumination source, a detector; and a processor comprising a software program for control of the illumination source and the photodetector and for processing data obtained from the photodetector; and   processing data corresponding to signal emitted from the test device by generating a one-dimensional data array of values corresponding to signal associated with the reference line and the analyte-specific test line in response to illumination by the illumination source, and calculating a first derivative of the one-dimensional array to generate a derivative data set, wherein a peak in the derivative data set corresponds to data from the reference line or the control line.   
     
     
         12 . The method of  claim 11 , wherein the test device is an immunoassay test device for detection of an analyte of interest. 
     
     
         13 . The method of  claim 12 , wherein the analyte of interest is an infectious analyte. 
     
     
         14 . The method of  claim 13 , wherein the infectious analyte is a virus or a bacteria. 
     
     
         15 . The method of  claim 11 , wherein the reference line comprises antibodies for non-specific binding to immunoglobulins present in a sample, and based on its fluorescent signal communicates to the processor whether sufficient sample has reached the reference line. 
     
     
         16 . The method of  claim 12 , wherein the test device comprises microparticles comprised of a fluorescing lanthanide compound and an antibody with binding specificity for the analyte of interest.