Detection of early stages and late stages hpv infection

Abstract

Embodiments of the invention provide methods, monoclonal antibodies, polyclonal antibodies, assays, and kits for detecting HPV infection and HPV related cancer diagnosis, including infection by various HPV genotypes, early and/or late stage HPV-associated or HPV-specific cancers. Various specific or pan monoclonal antibodies recognizing specific epitope for specific HPV protein or HPV type, or common epitope for various HPV proteins or HPV types are obtained. The invention also provides one or more solid surface to coat the testing cell lysate. Also, the anti-HPV antibody can be coated on the solid surface of the invention to capture HPV proteins and detect HPV infection.

1 . A lateral flow through device for detecting a papillomavirus protein from one or more papillomavirus types present in a clinical sample being processed into a cell lysate solution, comprising:
 a first solid surface on one end of a strip having a first anti-HPV antibody immobilized, wherein
 the first anti-HPV antibody is capable of binding to a papillomavirus protein from the one or more papillomavirus types such that the first anti-HPV antibody is able to capture the papillomavirus protein present in the cell lysate solution onto the solid surface; and 
   a second solid surface on the other end of the strip having a second anti-HPV antibody immobilized to react with the cell lysate solution flowing laterally from the first solid surface of the strip to form into a complex with second anti-HPV antibody on the second solid surface of the strip, wherein
 the second anti-HPV antibody is capable of binding to a papillomavirus protein such that the second anti-HPV antibody is able to bind and detect the papillomavirus protein present in the clinical sample. 
   
     
     
         2 . The lateral flow rapid test device of  claim 1 , wherein the second anti-HPV antibody is pre-labeled with a gold particle such that a colormetric complex of the gold particle-labeled second anti-HPV antibody and the papillomavirus protein can be visualized on the solid surface. 
     
     
         3 . A vertical flow-through rapid test device for detecting a papillomavirus protein from one or more papillomavirus types present in a clinical sample being processed into a cell lysate solution, comprising:
 a solid surface of a membrane having a first anti-HPV antibody immobilized, wherein
 the first anti-HPV antibody is generated against one or more first recombinant proteins encoded by one or more first papillomavirus genes such that the first anti-HPV antibody is able to react with the cell lysate solution and capture the one or more papillomavirus proteins in the cell lysate solution onto the solid surface; and 
   a second anti-HPV antibody to be added with the cell lysate solution onto the solid surface of the membrane for flowing vertically through the solid surface and forming into a complex with first anti-HPV antibody on the solid surface of the membrane, wherein
 the second anti-HPV antibody is generated against one or more second recombinant proteins encoded by one or more second papillomavirus genes such that the second anti-HPV antibody is able to bind and detect the one or more papillomavirus proteins in the cell lysate solution. 
   
     
     
         4 . The vertical flow-through rapid test device of  claim 3 , further comprising an pre-labeled antibody which is capable of binding to the second anti-HPV antibody, the pre-labeled antibody is labeled with an detection agent selected from a group comprising horse radish peroxidase conjugate, biotin, gold particle, and combinations thereof.