BMJ Open (May 2025)
Diagnostic value of BNLF2b antibody, dual-antibody testing and Epstein–Barr virus DNA in nasopharyngeal carcinoma: a prospective cohort study in Hunan Province, China
Abstract
Objectives This study evaluates the diagnostic value of the BNLF2b antibody, dual antibody testing and Epstein-Barr virus DNA (EBV-DNA) individually and in combination for nasopharyngeal carcinoma (NPC) detection.Design A prospective cohort study.Setting The study was conducted at Hunan Cancer Hospital, in a region in China with a high incidence of NPC, between January 2024 and June 2024.Participants A total of 350 patients with suspected NPC were enrolled based on clinical suspicion (eg, metastatic cervical lymph nodes or nasopharyngeal abnormalities with non-specific symptoms). The inclusion criteria included age ≥18 years, residency in Hunan Province, and provision of informed consent. The exclusion criteria included prior history of NPC or other head and neck malignancies, severe immunological/systemic diseases and inability to complete diagnostic evaluations.Primary and secondary outcome measures Demographic, clinical and biomarker data were collected, including BNLF2b antibody, EBV-DNA and dual antibody testing. Diagnostic performance metrics were calculated against histopathological confirmation as the gold standard. Follow-up assessments were conducted for non-NPC cases.Results Among 350 suspected NPC participants, 74 were diagnosed with NPC through biopsy. BNLF2b antibody exhibited the highest sensitivity (83.78%) and specificity (95.65%) among single biomarkers in NPC diagnosis, outperforming dual-antibody testing and EBV-DNA. Combining BNLF2b with dual-antibody testing improved specificity to 99.64%, although with reduced sensitivity (67.57%). NPC-diagnosed participants and those testing positive for BNLF2b or dual antibody biomarkers had a significantly higher prevalence of family history of NPC (p<0.05). Alcohol consumption was significantly more common among dual antibody-positive participants compared with antibody-negative participants (p<0.05). One NPC case was identified during follow-up, which tested positive for BNLF2b antibody and the dual antibody method at baseline and follow-up, underscoring the predictive value of these biomarkers.Conclusion The BNLF2b antibody is a highly sensitive and specific biomarker for NPC detection, particularly for early-stage disease. Combining BNLF2b with the dual antibody method enhances specificity, making it valuable for identifying at-risk individuals and guiding early interventions.