Cervista和MALDI-TOF-MS HPV法用于子宫颈癌筛查效果评价检测  

Evaluation Cervista and MALDI-TOF-MS for HPV Assay in Cervical Cancer Screening

作　　者：杜辉[1] 吴瑞芳[1] 李晶晶 杨斌 刘莹[1] 张礼捷[1] Belinson SE 吴若松 万宏 渠新风 Belinson JL 

机构地区：[1]北京大学深圳医院妇产科,广东深圳518036 [2]深圳华大基因研究院,广东深圳518000 [3]美国克利夫兰医学中心临床病理科 [4]国际防癌组织 [5]深圳瑞安迪妇科门诊部,广东深圳518000

出　　处：《深圳中西医结合杂志》2010年第3期132-136,共5页Shenzhen Journal of Integrated Traditional Chinese and Western Medicine

基　　金：深圳市科技局国际合作项目(GJ;200807240026A)

摘　　要：目的:中美合作深圳万例子宫颈癌筛查项目(SHENCCASTⅡ),主要研究目的就是评价人类乳头状瘤病毒(HPV)作为子宫颈癌初筛方法的可行性。笔者报道研究项目中期评估数据,以HybridCaptureII(HC-II)法HPV检测为对照,评价新的CervistaHPV检测方法和MALDI-TOF-MSHPV基因分型检测技术(MALDI-TOF-MS)在宫颈癌筛查中的效果。方法:本研究拟募集深圳市区、郊区及周边农村地区1万名年龄25岁至59岁、至少3年未参加过子宫颈癌筛查、未接受过子宫切除术及放疗、有过性生活的非孕期女性为筛查对象。宫颈细胞由医生取样,收集在PreservCyt细胞保存液中,首先液基细胞学制片,然后进行HC-Ⅱ、Cervista和MALDI-TOF-MS3种方法的HPV检测。细胞学≥ASCUS及任一方法HPV检测结果阳性者均进一步行阴道镜下四象限多点活检及ECC病理诊断。结果:5316例参加筛查女性中,5043例数据齐全。HC-Ⅱ、Cervist、MALDI-TOF-MS3种HPV检测方法HPV阳性率分别是:14.6%,12.2%,14%。发现CIN2以上病变150例,CIN3以上病变97例,宫颈癌5例。对于发现CIN2及以上病变,HC-Ⅱ、Cervista、MALDI-TOF-MS3种HPV检测的敏感性、特异性、阳性预测值、阴性预测值分别是:94.7%、87.9%、19.3%、99.8%;90.7%、90.2%、22%、99.7%和92.7%、88.4%、19.7%、99.8%。对于检出CIN3及以上病变,HC-Ⅱ、Cervista、MALDI-TOF-MS的敏感性、特异性、阳性预测值、阴性预测值分别是:97%、87%、12.8%、99.9%;91.8%、89.3%、14.4%、99.8%和94.9%、87.6%、13.1%、99.9%。Cervista和HC-Ⅱ、MALDI-TOF-MS的敏感性、特异性比较有统计学差异(P<0.01),但MALDI-TOF-MS和HC-Ⅱ比较没有显著差异。结论:HPV检测作为人群为基础的子宫颈癌筛查的初筛方法是可行的,MALDI-TOF-MSHPV检测的敏感性、特异性可与目前公认的金标准HC-Ⅱ法HPV检测相媲美,同时又因其检测的高通量、相对较低的价格,以及可行基因分型而更具应用前景。Objective The major study purpose of SHENCCASTⅡ（The Shenzhen Cervical Cancer Screening TrialⅡ）is to evaluate the feasibility of HPV as a primary cervical cancer screening based population.We report an interim evaluation of the new Cervista assay and MAILDI-TOF-MS for detection of HPV infection compared to HC-Ⅱ.Methods Women from Shenzhen urban,suburban and rural areas around the city were eligible if non-pregnant,25-59 yrs of age,no screening in 3 years,no hysterectomy,and no pelvic radiation.Cytology,HC-Ⅱ,the Cervistaassay,and MAILDI-TOF-MSwere all processed in that order from the same 20mL Preserv Cyt specimen,collected using the＂broom＂sampler.Any patient with≥ASCUS,positive on any other HPV test was requested to further examination colposcopy and four-quadrant biopsy plus ECC.Results 5043 women had all results.14.6%（736）were HC-Ⅱpositive,12.2%（617）were Cervista positive,and 14%（705）were MAILDI-TOF-MS positive.3.0%（150）had≥CIN 2,1.9%（97）≥CIN 3,0.10%（5）with cancer.For〉CIN2,the sensitivity,specificity PPV and NPV values for HC-Ⅱwere 94.7%,87.9%,19.3%and 99.8%respectively,that of Cervista were 90.7%,90.2%,22%and 99.7%and that of MAILDI-TOF-MS were 92.7%,88.4%,19.7%and 99.8%.For〉CIN3,HC-Ⅱwere 97%,87%,12.8%and 99.9%,Cervista were 91.8%,89.3%,14.4%and 99.8%and MAILDITOF-MS were 94.9%,87.6%,13.1%and 99.9%.Compared with results of cervista,the sensitivity and specificity of HC-Ⅱand MAILDI-TOF-MS were siginificantly different（P〈0.01）,and it have no significantly different between MAILDI-TOF-MS and HC-Ⅱ.Conclusion It is feasible for HPV as a primary cervical cancer screening based wide-scale population.High through-put,Type-specific data,low consumable cost and high sensitivity makes the MAILDI-TOF-MS potentially a more cost efficient approach.

关 键 词：子宫颈癌 筛查 CervistaHPV检测 MALDI-TOF-MSHPV检测 

分 类 号：R730.437[医药卫生—肿瘤] R737.33[医药卫生—临床医学]