ELISA Test for Autoantibodies to DeltaNp63alpha in Head and Neck Squamous Cell Carcinoma

Specific aims. To determine the autoantibody titer and percentage of head and neck squamous cell carcinoma (HNSCC) patients who have IgG and IgA serum autoantibodies to deltaNp63alpha that are detectable by Enzyme-Linked ImmunoSorbent Assay (ELISA). These results will contribute in providing an easy to administer and economical test for screening; monitoring response to treatment; obtaining a prognosis; and detecting the recurrence of HNSCC. Hypothesis. Patients with HNSCC have detectable titers of serum autoantibodies (IgG and/or IgA) to deltaNp63alpha; that will be detected by ELISA; while people without HNSCC will have either no serum autoantibodies to deltaNp63alpha or very low titers of these autoantibodies. Research design and methods. A case control study was performed with 100 sample sera from patients histopathologically diagnosed with HNSCC, and 100 sera from people without HNSCC as controls. Samples were blindly analyzed by ELISA to determine IgG and IgA autoantibodies. Results . For IgG, there is a statistical significant difference between means of cases and controls; with 54 percent sensitivity and 72 percent specificity. For IgA, no statistical significant difference exists between means of cases and controls with 75 percent sensitivity and 47 percent specificity. Conclusion. For IgG, although the result is statistically significant, it is not clinically significant, as the test sensitivity is relatively low. For IgA, the insignificant results can possibly be explained by the fact that only a proportion of HNSCC patients would develop IgA autoantibodies as a humoral response to over expression of deltaNp63alpha protein. The presence of these antibodies in control serum samples could be attributed to either another medical condition (autoimmune disease or other malignancy), or nonspecific antibody interactions with the deltaNp63 protein.