Direct Human Papillomavirus E6 Whole-Cell Enzyme-Linked Immunosorbent Assay for Objective Measurement of E6 Oncoproteins in Cytology Samples

A novel, whole-cell enzyme-linked immunosorbent assay (ELISA) based on a non-type-specific anti-human papillomavirus (HPV) E6 antibody was tested on 182 residual cytological specimens. For samples with a designation of more severe than cervical intraepithelial neoplasia grade 3 (CIN3), 83 % tested positive for E6; in a subset with paired testing for E6 ELISA and HPV DNA, 72 % tested E6 positive and 92 % tested high-risk (HR)-HPVDNA positive (P 0.2). Among the women with a less than CIN3 diagnosis, 31 % and 47 % tested positive for E6 and HR-HPVDNA, respectively (P 0.0006). Cervical cancer is the second most common cause of cancerdeaths in women worldwide. Routine screening and treat-ment have substantially decreased the cervical cancer mortality rate in theUnited States. However, according to theWorldHealth Organization, there are approximately 500,000 new cases and 250,000 deaths from cervical cancer every year worldwide. Al-though Pap tests and colposcopy have contributed tremendously to the decreased mortality of cervical cancer, they are subjective tests, prone to human error, and not always conclusive. Therefore, it is extremely important to develop more objective screening tools that can identify patients who aremost at risk for developin