Qu Bin, Sun Lisha, Deng Hongyu, Liu Qinglin, Shen Haoming, Xiao Ping
Hunan Key Laboratory of Oncotarget Gene, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/Hunan Cancer Hospital, Changsha, China.
Department of Blood Transfusion, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/Hunan Cancer Hospital, Changsha, China.
BMJ Open. 2025 May 21;15(5):e100538. doi: 10.1136/bmjopen-2025-100538.
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.
A prospective cohort study.
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.
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.
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.
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.
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.
本研究评估BNLF2b抗体、双抗体检测和爱泼斯坦-巴尔病毒DNA(EBV-DNA)单独及联合检测对鼻咽癌(NPC)的诊断价值。
一项前瞻性队列研究。
该研究于2024年1月至2024年6月在中国鼻咽癌高发地区的湖南省肿瘤医院进行。
基于临床怀疑(如转移性颈部淋巴结或伴有非特异性症状的鼻咽部异常)共纳入350例疑似NPC患者。纳入标准包括年龄≥18岁、居住在湖南省以及提供知情同意书。排除标准包括既往有NPC或其他头颈部恶性肿瘤病史、严重免疫/全身性疾病以及无法完成诊断评估。
收集人口统计学、临床和生物标志物数据,包括BNLF2b抗体、EBV-DNA和双抗体检测。以组织病理学确诊为金标准计算诊断性能指标。对非NPC病例进行随访评估。
在350例疑似NPC参与者中,74例通过活检确诊为NPC。在NPC诊断的单一生物标志物中,BNLF2b抗体表现出最高的敏感性(83.78%)和特异性(95.65%),优于双抗体检测和EBV-DNA。将BNLF2b与双抗体检测相结合可将特异性提高到99.64%,尽管敏感性有所降低(67.57%)。确诊为NPC的参与者以及BNLF2b或双抗体生物标志物检测呈阳性的参与者患NPC家族史的患病率显著更高(p<0.05)。与抗体阴性的参与者相比,双抗体阳性的参与者饮酒更为常见(p<0.05)。在随访期间确诊1例NPC病例,该病例在基线和随访时BNLF2b抗体和双抗体检测均呈阳性,突出了这些生物标志物的预测价值。
BNLF2b抗体是一种用于检测NPC的高度敏感和特异的生物标志物,尤其对于早期疾病。将BNLF2b与双抗体方法相结合可提高特异性,对识别高危个体和指导早期干预具有重要价值。