Point of care diagnostic systems

Abstract

Systems and methods for medical diagnosis or risk assessment for a patient are provided. These systems and methods are designed to be employed at the point of care, such as in emergency rooms and operating rooms, or in any situation in which a rapid and accurate result is desired. The systems and methods process patient data, particularly data from point of care diagnostic tests or assays, including immunoassays, electrocardiograms, X-rays and other such tests, and provide an indication of a medical condition or risk or absence thereof. The systems include an instrument for reading or evaluating the test data and software for converting the data into diagnostic or risk assessment information.

1 . A method for determining results from an immunoassay, comprising: 
 (a) testing a patient sample for the presence of a target analyte indicative of a condition or risk of having the condition by reacting the sample with antibodies specific for the analyte in a sandwich assay performed on a test strip, in which one of the antibodies is labeled with a detectable label; and    (b) detecting a reflectance signal produced by the label in a reflectance reader, wherein:    the reflectance reader includes a reader head that comprises: 
 (i) a reader head body;  
 (ii) a light emitting diode (LED);  
 (iii) a first fiberoptic bundle optically coupled to the light emitting diode;  
 (iv) a photodetector;  
 (v) a second fiberoptic bundle optically coupled to the photodetector; and  
 (vi) an aperture in the reader head body, 
 wherein fiberoptic conductor ends of the first fiberoptic bundle and fiberoptic conductor ends of the second fiberoptic bundle are arranged in a substantially co-planar relationship to form a planar surface, and the planar surface is substantially parallel to a plane at an upper surface of the test strip during reflectance signal detection, whereby light is conducted by fiberoptic bundles to the photodetector, which generates the reflectance signal indicative of an amount of reflected light; and  
 
   the reflectance signal is indicative of the presence of the analyte.    
     
     
         2 . The method of  claim 1 , wherein the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle are arranged in a sigmoidal distribution in the aperture.  
     
     
         3 . The method of  claim 1 , wherein the reader head further comprises a third fiberoptic bundle optically connected to a second light emitting diode, wherein fiberoptic conductor ends of the third fiberoptic bundle are arranged in a substantially coplanar relationship with the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle.  
     
     
         4 . The method of  claim 3 , wherein the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle and the fiberoptic conductor ends of the third fiberoptic bundle are arranged in a sigmoidal distribution in the aperture.  
     
     
         5 . The method of  claim 1 , wherein the target analyte is fetal fibronectin.