• Tingdong Li, Fugui Li, Xiaoyi Guo, Congming Hong, Xia Yu, Biaohua Wu, Shifeng Lian, Liuwei Song, Jiabao Tang, Shunhua Wen, Kaimin Gao, Mengling Hao, Weimin Cheng, Yingying Su, Shiyin Zhang, Shoujie Huang, Mujin Fang, Yingbin Wang, Mun-Hon Ng, Honglin Chen, Wenxin Luo, Shengxiang Ge, Jun Zhang, Ningshao Xia, and Mingfang Ji.
• From the State Key Laboratory of Vaccines for Infectious Diseases, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Department of Laboratory Medicine, School of Public Health, Xiamen University (T.L., X.G., C.H., J.T., M.H., Y.S., S.Z., S.H., M.F., Y.W., M.-H.N., W.L., S.G., J.Z., N.X.), and Xiamen Innodx Biotechnology (L.S., S.W., K.G.), Xiamen, the Cancer Research Institute of Zhongshan City, Zhongshan City People's Hospital, Zhongshan (F.L., X.Y., B.W., W.C., M.J.), and the State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong (H.C.) - all in China; and the Unit of Integrative Epidemiology, Institute of Environmental Medicine, Karolinska Institute, Stockholm (S.L.).
• N. Engl. J. Med. 2023 Aug 31; 389 (9): 808819808-819.

BackgroundPopulation screening of asymptomatic persons with Epstein-Barr virus (EBV) DNA or antibodies has improved the diagnosis of nasopharyngeal carcinoma and survival among affected persons. However, the positive predictive value of current screening strategies is unsatisfactory even in areas where nasopharyngeal carcinoma is endemic.MethodsWe designed a peptide library representing highly ranked B-cell epitopes of EBV coding sequences to identify novel serologic biomarkers for nasopharyngeal carcinoma. After a retrospective case-control study, the performance of the novel biomarker anti-BNLF2b total antibody (P85-Ab) was validated through a large-scale prospective screening program and compared with that of the standard two-antibody-based screening method (EBV nuclear antigen 1 [EBNA1]-IgA and EBV-specific viral capsid antigen [VCA]-IgA).ResultsP85-Ab was the most promising biomarker for nasopharyngeal carcinoma screening, with high sensitivity (94.4%; 95% confidence interval [CI], 86.4 to 97.8) and specificity (99.6%; 95% CI, 97.8 to 99.9) in the retrospective case-control study. Among the 24,852 eligible participants in the prospective cohort, 47 cases of nasopharyngeal carcinoma (38 at an early stage) were identified. P85-Ab showed higher sensitivity than the two-antibody method (97.9% vs. 72.3%; ratio, 1.4 [95% CI, 1.1 to 1.6]), higher specificity (98.3% vs. 97.0%; ratio, 1.01 [95% CI, 1.01 to 1.02]), and a higher positive predictive value (10.0% vs. 4.3%; ratio, 2.3 [95% CI, 1.8 to 2.8]). The combination of P85-Ab and the two-antibody method markedly increased the positive predictive value to 44.6% (95% CI, 33.8 to 55.9), with sensitivity of 70.2% (95% CI, 56.0 to 81.4).ConclusionsOur results suggest that P85-Ab is a promising novel biomarker for nasopharyngeal carcinoma screening, with higher sensitivity, specificity, and positive predictive value than the standard two-antibody method. (Funded by the National Key Research and Development Program of China and others; ClinicalTrials.gov number, NCT04085900.).Copyright © 2023 Massachusetts Medical Society.

33 keywords...

hide…