BRAF V600E (RM8抗体)免疫组化检测在基层医院甲状腺乳头状癌诊断中的性能评估

Performance Evaluation of BRAF V600E (RM8 Antibody) Immunohistochemistry in the Diagnosis of Papillary Thyroid Carcinoma in Primary Hospitals

摘要: 目的：针对指南推荐的BRAF V600E (VE1)抗体价格偏高、基层难以普及，而替代抗体缺乏性能数据的现实矛盾，评估BRAF V600E (RM8抗体)免疫组化在基层医院甲状腺乳头状癌(papillary thyroid carcinoma, PTC)诊断中的效能，提供经济可行的替代检测方案。方法：收集2023年7月至2025年7月重庆市长寿区妇幼保健院病理确诊的52例PTC及13例甲状腺良性病变组织，行BRAF V600E (RM8抗体)免疫组化检测，并以荧光PCR为金标准验证。计算诊断效能指标及一致性，分析突变状态与组织学亚型的关联。结果：52例PTC中BRAF V600E突变率为80.8% (42/52)。以荧光PCR为金标准，RM8免疫组化的敏感性为90.5% (38/42)、特异性为91.3% (21/23)、总符合率为90.8%，Kappa值为0.778，与基因检测高度一致。良恶性病变中RM8免疫组化阳性率差异显著(P < 0.001)，且BRAF V600E野生型PTC与浸润性滤泡亚型显著相关(P < 0.001)。结论：BRAF V600E (RM8抗体)免疫组化与分子检测高度一致，具有良好的诊断效能，且比BRAF V600E (VE1抗体)更具成本效益，是基层医院经济可靠的替代选择，可显著提升PTC精准诊断的可及性。

Abstract: Objective: Aiming at the practical contradiction that the guideline-recommended BRAF V600E (VE1) antibody is expensive and difficult to popularize in primary hospitals, while the alternative antibody lacks systematic performance verification, this study evaluated the diagnostic efficacy of BRAF V600E (RM8 antibody) immunohistochemistry (IHC) for papillary thyroid carcinoma (PTC) in primary hospitals, so as to provide an economical and reliable alternative detection scheme for primary hospitals. Methods: A total of 52 cases of PTC and 13 cases of benign thyroid lesions pathologically confirmed in Chongqing Changshou Maternal and Child Health Hospital from July 2023 to July 2025 were collected. BRAF V600E (RM8 antibody) IHC was performed, with fluorescent PCR as the gold standard. The diagnostic efficiency, consistency, and the correlation between mutation status and histological subtypes were analyzed. Results: The BRAF V600E mutation rate in 52 PTC cases was 80.8% (42/52). The sensitivity, specificity, and total coincidence rate of RM8 IHC were 90.5% (38/42), 91.3% (21/23), and 90.8%, respectively, with a Kappa value of 0.778, showing high consistency with genetic detection. There was a significant difference in the positive rate between benign and malignant lesions (P < 0.001), and BRAF V600E wild-type PTC was significantly associated with the infiltrative follicular subtype (P < 0.001). Conclusion: BRAF V600E (RM8 antibody) IHC has high consistency with molecular detection and good diagnostic performance, with better cost-effectiveness than VE1 antibody. It is an economical and reliable alternative for accurate diagnosis of PTC in primary hospitals, and can significantly improve the accessibility of diagnosis in primary hospitals.