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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: Sino-US cooperation Shenzhen million cases of cervical cancer screening project (SHENCCAST Ⅱ), the main purpose of the study is to evaluate the feasibility of human papilloma virus (HPV) as a screening method for cervical cancer. The author reported the mid-term evaluation data of the research project. The HPV test of HybridCapture II (HC-II) was used as a control to evaluate the new Cervista HPV detection and MALDI-TOF-MSHPV genotyping (MALDI-TOF- In the effect. Methods: This study was to raise 10,000 urban residents aged 25 to 59 years old in urban area, suburban area and surrounding countryside in Shenzhen City, at least 3 years without cervical cancer screening, without hysterectomy and radiotherapy and with sex life Of non-pregnant women as screening targets. Cervical cells were sampled by physicians and collected in PreservCyt cell preservation solution, first in liquid-based cytology and then HPV testing by the HC-II, Cervista and MALDI-TOF-MS methods. Cytology ≥ASCUS and any method of HPV test results were further colposcopic multi-quadrant biopsy and ECC pathological diagnosis. Results: Of the 5316 women enrolled in screening, 5043 cases were complete. The HPV positive rates of HC-Ⅱ, Cervist and MALDI-TOF-MS were 14.6%, 12.2% and 14%, respectively. 150 cases of lesions above CIN2 were found, 97 cases of lesions above CIN3 and 5 cases of cervical cancer. The sensitivity, specificity, positive predictive value and negative predictive value of the HPV test for detecting CIN2 and above lesions were 94.7%, 87.9%, 19.3% and 99.8% for HC-Ⅱ, Cervista and MALDI-TOF- 90.7%, 90.2%, 22%, 99.7% and 92.7%, 88.4%, 19.7%, 99.8%. The sensitivity, specificity, positive predictive value and negative predictive value of HC-Ⅱ, Cervista and MALDI-TOF-MS were 97%, 87%, 12.8% and 99.9% , 89.3%, 14.4%, 99.8% and 94.9%, 87.6%, 13.1%, 99.9%. The sensitivity and specificity of Cervista and HC-Ⅱ and MALDI-TOF-MS were statistically different (P <0.01), but there was no significant difference between MALDI-TOF-MS and HC-Ⅱ. CONCLUSIONS: HPV testing is feasible as a screening method for population-based cervical cancer screening. The sensitivity and specificity of the MALDI-TOF-MSHPV test are comparable to those of the currently accepted gold standard HC-Ⅱ HPV test, At the same time because of its high-throughput detection, the relatively low price, and feasible genotyping and more application prospects.