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

There is also great interest in rapid point of care tests for infection, cancer, and autoimmunity [32] . The most common POC directed at diagnostic antibodies are based on lateral flow and microfluidic devices. One recent study showed that a microfluidic device coupled with immunoassay detected HPV-16 E6 antibodies with moderate diagnostic sensitivity and specificity but required at least an hour for processing [10] . Here, the one-minute LIPSTICKS assay performed quite well to detect HPV-16 E6 antibodies associated with HNSCC. While some of the HNSCC subjects showed relatively dramatic differences between the negative and positive samples, other subjects were less easily detected as seropositive and fell near the cut-off value and one sample was negative. We anticipate that further improvements in the E6 HPV-16 LIPSTICK assay related to antigen design and assay standardization will further enhance test performance. One limitation of our study was the relatively small cohort that was tested. Exploring whether LIPSTICKS can detect HPV-associated HNSCC in a larger well-characterized cohort is warranted.