DETECTION OF EARLY STAGES AND LATE STAGES HPV INFECTION
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 flow through device for detecting a human papillomavirus (HPV) protein resent in a clinical sample, comprising:
a first solid surface on one end of a strip having an immobilized first anti-HPV antibody, and
a second solid surface on a second region of the strip, wherein
the second solid surface comprises a well for receiving the clinical sample and a second anti-HPV antibody, wherein
the second anti-HPV antibody is capable of binding to the HPV protein in the clinical sample to form a complex, and, wherein
the complex is capable of flowing from the second region to the first solid surface, wherein the complex is capable of being captured by the immobilized anti-HPV antibody,
the first and/or the second antibody is capable of specifically binding in situ to two or more native HPV proteins in the clinical sample,
the two or more native HPV proteins are from different HPV types, and
the two or more native HPV proteins are native HPV E7 proteins from different HPV types or native HPV E6 proteins from different HPV types.
2 . The flow through device of claim 1 , wherein the second anti-HPV antibody is labeled with a gold particle such that the complex is colorimetric and can be visualized on the first solid surface.
3 . The flow through device of claim 1 , wherein the HPV protein has an HPV type selected from the group consisting of high risk HPV types, low risk HPV types, HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, and HPV-68, HPV-6, HPV-11, HPV-42, HPV-43, HPV-44, HPV-53, HPV-54, HPV-55, and HPV-56.
4 . The flow through device of claim 1 , wherein the clinical sample is processed into a cell lysate solution.
5 . The flow through device of claim 1 , wherein the solid surface is a solid surface of a membrane.
6 . The flow through device of claim 1 , wherein the flow through device is a lateral flow through device.
7 . The flow through device of claim 1 , wherein the flow through device is a vertical flow through device.
8 . The vertical flow through device of claim 10 , wherein the second anti-HPV antibody binds to a third antibody that is labeled with a detection agent comprising horse radish peroxidase conjugate, biotin, or gold particle.