Method and Device for Combined Detection of Viral and Bacterial Infections

Abstract

A lateral flow assay is capable of detecting and differentiating viral and bacterial infections. A combined point of care diagnostic device tests markers for viral infection and markers for bacterial infection, to effectively assist in the rapid differentiation of viral and bacterial infections. In some preferred embodiments, bimodal methods and devices determine if an infection is bacterial and/or viral. A dual use two strip sample analysis device includes a first lateral flow chromatographic test strip to detect MxA and a low level of C-reactive protein and a second lateral flow chromatographic test strip to detect high levels of C-reactive protein. In some preferred embodiments, the sample is a fingerstick blood sample.

1 .- 45 . (canceled) 
     
     
         46 . A method to simultaneously detect at least one extracellular analyte and at least one intracellular analyte, comprising the steps of:
 a) collecting a sample;   b) transferring the sample to a sample analysis device;   c) lysing the sample; and   d) simultaneously detecting the extracellular analyte and the intracellular analyte on the sample analysis device.   
     
     
         47 . The method of  claim 46 , wherein the extracellular analyte is C-reactive protein and the intracellular analyte is MxA protein. 
     
     
         48 . The method of  claim 46 , wherein the sample is a blood sample. 
     
     
         49 . A method of detecting MxA protein and C-reactive protein in a sample, comprising the steps of:
 a) adding the sample to a mixture of an antibody to MxA protein conjugated to a first label and an antibody to C-reactive protein conjugated to a second label different from the first label;   b) detecting a presence of MxA protein by determining whether the antibody to MxA protein has agglutinated; and   c) detecting a presence of C-reactive protein by determining whether the antibody to C-reactive protein has agglutinated.   
     
     
         50 . The method of  claim 49 , further comprising, before step a), the steps of:
 d) conjugating the antibody to MxA protein to the first label;   e) conjugating the antibody to C-reactive protein to the second label.   
     
     
         51 . A method of detecting the presence of an unknown viral infection, comprising the steps of:
 a) collecting a sample;   b) transferring the sample to a sample application zone of a sample analysis device comprising:
 i) a conjugate zone comprising a sialic acid nanomicelle comprising a label inside the nanomicelle; and 
 ii) a detection zone laterally downstream from the sample application zone, comprising a sialic acid homolog nanoparticle; 
   c) analyzing the sample for a positive result in the detection zone.   
     
     
         52 . A method of detecting the presence of a specific viral infection, comprising the steps of:
 a) collecting a sample;   b) transferring the sample to a sample application zone of a sample analysis device comprising:
 i) a conjugate zone comprising a molecule selected from the group consisting of: a nanomicelle comprising a binding partner for a specific virus that causes the viral infection and a label; and a sialic acid homolog nanomicelle comprising a label inside the nanomicelle; and 
 ii) a detection zone laterally downstream from the sample application zone, comprising a nanoparticle specific for the virus that causes the viral infection. 
   c) analyzing the sample for a positive result in the detection zone.