p16和HPV DNA检测在ASC-US分流中的价值研究  

Value of p16 and HPV DNA detection in ASC-US shunt

作　　者：游伟强 王莉平 吴小延[2] 叶才果 方小龙 林立鹏 YOU Weiqiang;WANG Liping;WU Xiaoyan;YE Caiguo;FANG Xiaolong;LIN Lipeng(Department of Clinical Laboratory,Shenzhen Futian District Maternity and Child Healthcare Hospital,Shenzhen 518016,China;Department of Molecular Diagnosis,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;Key Laboratory of Medical Molecular Diagnosis,Guangdong Province Affiliated to Guangdong Medical University,Dongguan 523808,China)

机构地区：[1]深圳市福田区妇幼保健院检验科,深圳518016 [2]中山大学肿瘤防治中心分子诊断科,广州510060 [3]广东医科大学广东省医学分子诊断重点实验室,东莞523808

出　　处：《广州医药》2022年第4期30-35,41,共7页Guangzhou Medical Journal

基　　金：国家自然科学基金(81572782);广东省医学科学技术研究基金(A2021379)。

摘　　要：目的探讨p16免疫细胞化学、人乳头瘤病毒(HPV)DNA基因分型单独和联合检测在宫颈细胞学不能明确诊断意义的非典型鳞状上皮细胞(ASC-US)分流中的价值。方法收集2017年3月—2022年1月,585例液基薄层细胞学(TCT)诊断为ASC-US患者的宫颈细胞学标本,使用免疫细胞化学法行p16蛋白检测,生物芯片法行HPV DNA基因分型检测,患者于8周内行阴道镜下病理活检术。以组织学诊断结果为金标准,探讨p16免疫细胞化学和HPV DNA基因分型单独和联合检测方法在同一级别宫颈病变中阳性率的差异,对比同一检测方法在不同级别宫颈病变中阳性率的差异,比较p16免疫细胞化学、HPV DNA基因分型单独和联合检测对高级别鳞状上皮内病变(HSIL)以上病变诊断效能的差异,综合评定一种最优的ASC-US分流方法。结果①(p16+HPV DNA)联合检测在同一级别宫颈病变中阳性率高于p16免疫细胞化学、HPV DNA基因分型检测。②p16免疫细胞化学、HPV DNA基因分型、(p16+HPV DNA)联合检测的阳性率均随着宫颈病变程度的加重而递增。③(p16+HPV DNA)联合检测的综合诊断效能最佳,其灵敏度、特异度、符合率和约登指数分别为99.07%、62.55%、69.23%、0.62。结论p16免疫细胞化学检测法与HPV DNA基因分型单独和联合检测均有助于ASC-US分流,但是,(p16+HPV DNA)联合检测具有更优的灵敏度和约登指数,同时保持了较高的特异度和符合率,可有效进行ASC-US分流。Objective To investigate the value of p16 immunocytochemistry and human papillomavirus(HPV)DNA genotyping alone and combined in atypical squamous cells of undetermined significance(ASC-US)shunt which cervical cytology can not clearly diagnose.Methods From March 2017 to January 2022,cervical cytological specimens of 585 patients with ASC-US diagnosed by liquid based thinprep cytology test(TCT)were collected.p16 protein was detected by immunocytochemistry,HPV DNA genotype was detected by biochip and the patients underwent colposcopy pathological biopsy within 8 weeks.Taking the histological diagnosis results as the gold standard,the differences of the positive rate of p16 immunocytochemistry and HPV DNA genotyping in the same level of cervical lesions,differences of the positive rate of the same detection method in different levels of cervical lesions and differenes of p16 immunocytochemistry HPV DNA genotyping alone and combined detection of the diagnostic efficacy of lesions severer than high-grade squamous intraepithelial lesion(HSIL)were compared to comprehensively evaluate an optimal ASC-US shunt method.Results①The positive rate of combined detection of(p16+HPV DNA)in the same level of cervical lesions was higher than that of differences of p16 immunocytochemistry and HPV DNA genotyping.②The positive rate of combined detection of(p16+HPV DNA),p16 immunocytochemistry and HPV DNA genotyping increased with the aggravation of cervical lesions.③The combined detection of(p16+HPV DNA)had the best comprehensive diagnostic efficiency and its sensitivity,specificity,coincidence rate and Yoden index were 99.07%,62.55%,69.23% and 0.62 respectively.Conclusions p16 immunocytochemical assay and HPV DNA genotyping,both alone and in combination,contributed to ASC-US shunt.However,the combined detection of(p16+HPV DNA)had better sensitivity and Yoden index,with high specificity and coincidence rate,which can effectively carry out ASC-US shunt.

关 键 词：P16蛋白 免疫细胞化学 人乳头状瘤病毒 不能明确诊断意义的非典型鳞状上皮细胞 宫颈上皮内瘤变 宫颈癌 

分 类 号：R737.33[医药卫生—肿瘤]