Clinical evaluation of human papillomavirus 16/18 oncoprotein test for cervical cancer screening and HPV positive women triage.

Abstract

HPV-16 and -18 account for about 80% of cervical cancers. We evaluated the performance of HPV-16/18 oncoprotein to predict precancer and cancer in corresponding tissue biopsy specimens. 1,008 women attending cervical cancer screening program and 638 women referred to colposcopy with biopsy-confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) from 4 hospitals were recruited (1,646 in total). All women were tested OncoE6 (AVC), Liquid-Based Cytology (Hologic) and cobas HPV test (Roche). Colposcopy was performed on women with any abnormal results. The final diagnoses were based on a consensus panel review of the histology. There were 919 normal, 69 CIN1, 53 CIN2, 91 CIN3,474 squamous cell carcinoma(SCC) and 40 adenocarcinoma (ADC) cases, the prevalence of OncoE6 was 1.7%, 10.1%, 13.2%, 44.0%, 80.4% and 65.0%, respectively. The percent positive for cobas was higher than that of OncoE6 in detection of HPV16/18 in entire population (p < 0.001). However, the disparity of positive rate between these two tests became tiny among cervical cancer patients (CIN2: 26.4% vs. 13.2%, CIN3: 73.6% vs. 44.0%, SCC: 84.0% vs. 80.4%, ADC: 67.5% vs. 65.0%). OncoE6 was less sensitive than cobas (73.9% vs. 93.6%, p < 0.001), but more specific (97.1% vs. 75.4%, p < 0.001) for CIN3+ in entire population; OncoE6 yielded a sensitivity of 77.7% and a specificity of 91.0% for CIN3+ among cobas positive women, which can reduce nearly half of the colposcopy referral numbers. OncoE6 can be considered as a useful tool for cervical cancer screening and a potential powerful biomarker for HPV positive triage.

• Authors: Lulu Yu, Mingyue Jiang, Pengpeng Qu, Zeni Wu, Peisong Sun, Mingrong Xi, Yu Qin, Xin Liu, Guangdong Liao, Xiaoqin Lei, Lixin Sun, Yongzhen Zhang, Zhifang Li, Wen Chen, You-Lin Qiao
• Journal: International journal of cancer (Int J Cancer) Vol. 143 Issue 4 Pg. 813-822 (08 15 2018) ISSN: 1097-0215 [Electronic] United States
• PMID: 29524206 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 UICC.

Chemical References

• DNA, Viral

Topics

• Adenocarcinoma (diagnosis, pathology, virology)
• Adult
• Aged
• Carcinoma, Squamous Cell (diagnosis, pathology, virology)
• Colposcopy
• Cross-Sectional Studies
• DNA, Viral (analysis)
• Early Detection of Cancer (methods)
• Female
• Genetic Testing (standards)
• Human papillomavirus 16 (genetics, isolation & purification)
• Human papillomavirus 18 (genetics, isolation & purification)
• Humans
• Liquid Biopsy
• Middle Aged
• Papanicolaou Test
• Papillomavirus Infections (diagnosis, pathology)
• Sensitivity and Specificity
• Triage
• Uterine Cervical Neoplasms (diagnosis, pathology, virology)
• Young Adult