Luciferase-Based Detection of Antibodies for the Diagnosis of HPV-Associated Head and Neck Squamous Cell Carcinoma

Burbelo, Peter D.; Chaturvedi, Adrija; Notkins, Abner L.; Gunti, Sreenivasulu

Informed written consent was obtained from all subjects in accordance with the human experimentation guidelines of the Department of Health and Human Services under IRB-approved protocols, and the studies were conducted according to the principles expressed in the Declaration of Helsinki. All human samples utilized in this report represented de-identified serum specimens with annotated data. Healthy volunteer (HV) blood donor controls were obtained from the NIH Blood Bank, Clinical Center, NIH, Bethesda, Maryland under NCT00001846 (entitled "Collection and distribution of blood components from healthy donors for in vitro research use"). The serum samples from colon cancer (CC), systemic lupus erythematosus (SLE), and HNSCC patients used in this report were obtained from Conversant Bio (601 Genome Way Suite 1200, Huntsville, Alabama 35806). Subjects provided written informed consent under the Western Institutional Review Board approved by Conversant Bio. All human serum samples from Conversant Bio were collected, processed, and distributed in full ethical and regulatory compliance with the sites from which they were collected. This includes independent ethical review, Institutional Review Board approval (where appropriate), independent regulatory review, and Conversant Bioethical review.