Diagnostic Device

Abstract

Diagnostic devices for detecting the presence of an analyte in a sample are provided. Devices of the present invention comprise a means for inducing a pressure differential on a sample to direct the sample to a test surface. In one embodiment, the means for inducing a pressure differential on a sample to direct the sample to a test surface comprises a syringe that can be used to draw a sample from an opening to a test surface. In other embodiments, the device also provides means for diluting a sample. In yet other embodiments, the device also provides a means

1 - 34 . (canceled) 
     
     
         35 . A method for testing a sample comprising:
 introducing a sample into the opening of a diagnostic device comprising a syringe having a piston, the diagnostic device further comprising a test strip removably attached to the diagnostic device housing, wherein the test strip defines a test surface;   inducing a first negative pressure differential on the sample by engaging the syringe to position the piston to a first indicator, the first indicator positioned to correspond to a pressure differential that directs the sample through a first channel and into a first chamber;   inducing a second negative pressure differential by engaging the syringe to position the piston to a second indicator, the second indicator positioned to correspond to a pressure differential that directs the sample from the first chamber to the test surface and thereafter removing an unreacted portion of the sample from the test surface, through a second channel and into a second chamber.   
     
     
         36 . The method of  claim 35 , wherein the test surface is a diffraction-based test surface. 
     
     
         37 . The method of  claim 36 , wherein the device further comprises diffraction-enhancing elements. 
     
     
         38 . The method of  claim 36 , wherein the test surface is defined by a polymer film or metal-coated polymer film. 
     
     
         39 . The method of  claim 35 , wherein the second chamber has a volume sufficient to contain the entire sample. 
     
     
         40 . The method of  claim 35 , further comprising directing the sample from the opening through a third channel and into a third chamber located upstream of the first chamber, the third chamber in fluid communication with the first channel. 
     
     
         41 . The method of  claim 40 , wherein the third chamber comprises a means for separating one or more components from the sample comprising a filter, membrane, film, nonwoven, paper, precipitating agent, cell lysing agent, or combination thereof. 
     
     
         42 . The method of  claim 41 , wherein the means for separating one or more components from the sample removes red blood cells from the sample. 
     
     
         43 . The method of  claim 40 , wherein the third chamber comprises a means for diluting the sample comprising a diluent. 
     
     
         44 . The method of  claim 40 , wherein the diagnostic device further comprises a third indicator corresponding to a third piston position that indicates the sample has reached the third chamber. 
     
     
         45 . The method of  claim 35 , further comprising applying the test surface with an analyte-specific binder. 
     
     
         46 . The method of  claim 35 , wherein the first channel is formed by a capillary tube. 
     
     
         47 . The method of  claim 35 , wherein the sample is blood. 
     
     
         48 . A method for testing a sample comprising:
 introducing a sample into the opening of a diagnostic device comprising a syringe having a piston, the diagnostic device further comprising a test strip wherein the test strip defines a test surface;   inducing a first negative pressure differential on the sample by engaging the syringe to position the piston to a third indicator, the third indicator positioned to correspond to a pressure differential that directs the sample through a third channel and into a third chamber;   inducing a second negative pressure differential by engaging the syringe to position the piston to a first indicator, the first indicator positioned to correspond to a pressure differential that directs the sample from a third chamber through a first channel and into a first chamber;   inducing a third negative pressure differential by engaging the syringe to position the piston to a second indicator, the second indicator positioned to correspond to a pressure differential that directs the sample from the first chamber to the test surface and thereafter removing an unreacted portion of the sample from the test surface, through a second channel and into a second chamber.   
     
     
         49 . The method of  claim 48 , wherein the test strip is removably attached to the diagnostic device housing. 
     
     
         50 . The method of  claim 48 , wherein the test surface is a diffraction-based test surface. 
     
     
         51 . The method of  claim 50 , wherein the device further comprises diffraction-enhancing elements. 
     
     
         52 . The method of  claim 50 , wherein the test surface is defined by a polymer film or metal-coated polymer film. 
     
     
         53 . The method of  claim 48 , wherein the second chamber has a volume sufficient to contain the entire sample. 
     
     
         54 . The method of  claim 48 , wherein the third chamber comprises a means for separating one or more components from the sample comprising a filter, membrane, film, nonwoven, paper, precipitating agent, cell lysing agent, or combination thereof. 
     
     
         55 . The method of  claim 54 , wherein the means for separating one or more components from the sample removes red blood cells from the sample. 
     
     
         56 . The method of  claim 48 , wherein the third chamber comprises a means for diluting the sample comprising a diluent. 
     
     
         57 . The method of  claim 48 , further comprising applying the test surface with an analyte-specific binder. 
     
     
         58 . The method of  claim 48 , wherein the sample is blood.