APTIMA HPV E6/E7 mRNA和MALDI-TOF-MS HPV基因分型检测宫颈高度病变效果评价  

Evaluation of APTIMA HPV E6 /E7 mRNA assay and MALDI-TOF-MS HPV genotyping assay for the detection of high-grade cervical lesions

作　　者：杜辉[1] 张艳萍[1] 张薇[1] 王纯[1] 吴若松 Belinson JL 吴瑞芳[1] 

机构地区：[1]北京大学深圳医院妇产科,深圳市女性重大疾病早期诊断技术重点实验室,深圳518036 [2]深圳瑞安迪妇科门诊部,深圳518036 [3]美国国际防癌组织

出　　处：《现代妇产科进展》2014年第12期937-941,共5页Progress in Obstetrics and Gynecology

摘　　要：目的：以HC-Ⅱ法HPV DNA为对照,评价APTIMA法HPV E6/E7 mRNA检测（A-HPV）和MALDI-TOF-MS HPV分型检测技术（M-HPV）用于宫颈癌与癌前病变筛查的临床价值。方法：深圳市25-59岁、3年内未行宫颈癌筛查、未接受过子宫切除和盆腔放疗的2095例未孕妇女参加了本次筛查。医生于患者宫颈外口处直接收集2份宫颈脱落细胞标本,一份用于液基细胞学检查,一份用于HC-Ⅱ、A-HPV和M-HPV检测。宫颈细胞学≥ASCUS及3种方法 HPV检测任一阳性结果者均回叫行阴道镜下定点或四象限活检及宫颈管诊刮（ECC）。以病理诊断为标准评价各种HPV检测方法用于宫颈癌筛查的价值。结果：2095例研究对象中各项检测数据齐全者1970例。1970例患者的平均年龄为（35.89±7.655）岁。细胞学≥ASCUS者占6.4%（127/1970）,CINⅡ＋者占1.3%（26/1970）,CINⅢ＋者占0.76%（15/1970）。HC-Ⅱ、A-HPV和M-HPV总的HPV阳性率分别是19.4%、12.1%和14.8%,差异有统计学意义（P〈0.05）。HC-Ⅱ、A-HPV和M-HPV对检出CINⅡ＋病变的敏感性分别为88.5%（95%CI为68.7-97.0）、100%（95%CI为84.0-100）和92.3%（95%CI为73.4-98.7）,特异性分别为81.5（95%CI为79.7-83.2）、89.1%（95%CI为87.6-90.4）和86.3%（95%CI为84.6-87.8）;A-HPV与HC-Ⅱ相比敏感性稍高（P〈0.05）,M-HPV敏感性和HC-Ⅱ相同（P〉0.05）,三者比较有统计学意义（P〈0.05）。结论：A-HPV和M-HPV用于宫颈癌筛查都有很好的敏感性和准确性,两者活检率明显低于HC-Ⅱ,可减少医疗负担和花费。HPV亚型分型和HPV E6/E7 mRNA结合有更好地预测宫颈癌患病风险的作用。Objective：To assess the clinical sensitivity and specificity of the APTIMA HPV E6/E7 mRNA assay （A-HPV） and MALDI-TOF-MS HPV genotyping assay （M-HPV） for the detection of high-grade cervical lesions. Methods：The study populations were enrolled from Shenzhen,2095 women ages 25 - 59, non-pregnant, no screening in 〈3 years,no hysterectomy or pelvic irradiation. Cervical sample obtained for SurePath cytology. A second sample collected in PreservCyt liquid（PC） was used for Hybrid Capture Ⅱ assay（ HC-Ⅱ） ,APTIMA E6/ E7 HPV mRNA assay （ A-HPV ） and MALDI-TOF MS HPV genotyping assay （M-HPV）. Participants positive on any test were recalled for colposcopy and biopsy. All participants colposcoped had directed and random biopsies plus ECC（ min. 5 bx/patient）. Histology confirmed 〉 CIN Ⅱ^＋ served as the gold standard. Results： 1970 cases among of 2095 women had all test results. Mean age （SD）= 35.89（7.6） ,The ≥ASCUS prevalence was 6.4% （127/1970） ,Biopsy≥CIN Ⅱ 1.3% （26/1970） and ≥ CIN Ⅲ 0 76% （15/1970）. Overall HPV positivity was 19.4%, 12.1% and 14.8% for HC- Ⅱ , A-HPV and M-HPV respectively （P〈0.05）. Clinical sensitivity for detection of ≥CIN Ⅱ were 88.5% （68.7 - 97.0）, 100% （84.0 - 100） and 92.3% （73.4 -98.7 ） for HC-Ⅱ, A-HPV and M-HPV, respectively. A-HPV was slightly higher than HC- Ⅱ. There was not statistically significant between HC- Ⅱ and M-HPV. The specificity for CIN Ⅱ was 81.5% （79.7 - 83.2） ,89.1% （87.6 -90.4） and 86.3% （84.6 - 87.8） for HC- Ⅱ, A-HPV and M-HPV respectively （ P 〉 0.05, not statistically significant）. Conclusions ： The A-HPV and M-HPV has good sensitivity, accuracy, and has lower rate of biopsy compared to the HC-Ⅱ for detection of≥CIN Ⅱ lesions （P〈0.05）. Which may improve patient management and reduce the cost of care. High risk HPV genotyping combined HPV E6/E7 m RNA can identify women at highest risk for high-grade cervical disease.

关 键 词：人群为基础的宫颈癌筛查 APTIMA HPV E6/E7 MRNA检测 MALDI-TOF-MS HPV基因分型检测 

分 类 号：R737.33[医药卫生—肿瘤]