Methods and reagents for zika virus immunoassays

Abstract

Disclosed herein are immunoassay methods and reagents for detecting anti-Zika IgM antibody in a biological sample from a subject and/or diagnosing Zika virus infection in a subject. Also disclosed are algorithms for implementing the disclosed methods. The disclosed immunoassay methods, reagents, and algorithms enable efficient and reliable qualitative detection of anti-Zika virus antibodies and rapid determination of presumptive positive results for Zika virus infection in human subjects.

What is claimed is: 
     
         1 . A kit comprising:
 a solid support,   comprising an anti-human IgM antibody,   a buffer comprising an anti-human IgG Fc antibody, and   a labeled Zika virus antigen.   
     
     
         2 . The kit of  claim 1 , wherein the label comprises an enzyme conjugate, a fluorescent probe, a radioactive isotope, a chemiluminescent compound, a bioluminescent compound, or a combination thereof. 
     
     
         3 . The kit of  claim 2 , wherein the label is an acridinium ester (AE) or an analog thereof. 
     
     
         4 . The kit of  claim 1 , wherein the solid support comprises a column matrix material, a culture plate, a tube, a dish, a flask, a microtiter plate, a bead, a microparticle, or a combination thereof. 
     
     
         5 . The kit of  claim 4 , wherein the solid support is a paramagnetic particle (PMP) or a latex magnetic particle (LMP). 
     
     
         6 . A kit comprising reagents for a first immunoassay and reagents for a second immunoassay,
 wherein the reagents for the first immunoassay comprise:
 a solid support comprising an anti-human IgM antibody, 
 a buffer comprising an anti-human IgG Fc antibody, and 
 a labeled Zika virus antigen; and 
   wherein the reagents for the second immunoassay comprise:
 a solid support comprising an anti-human IgM antibody, and 
 a labeled Zika virus antigen. 
   
     
     
         7 . The kit of  claim 6 , further comprising instructions for performing the first and the second immunoassays, wherein the instructions direct a user to perform the first immunoassay to determine the presence or absence of anti-Zika virus antibodies in a biological sample from a human subject, and wherein the instructions further direct the user to perform the second immunoassay only if it is determined in the first immunoassay that the biological sample is positive for anti-Zika virus antibodies.