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目的:比较酶切信号放大法(Cervista)与导流杂交基因芯片技术(Hybri Ma)检测高危型人乳头状瘤病毒(HR-HPV)诊断宫颈上皮内瘤变2级或2级以上(CIN2+)的临床价值。方法:随机选择288例2012年3月至2013年1月在哈尔滨医科大学附属第一医院妇科门诊进行新柏氏液基细胞学检查的年龄在20~65岁的宫颈细胞学检测未明确意义的不典型鳞状细胞(ASCUS)的患者,采用Cervista技术与Hybri Ma技术进行高危型HPV检测,并对入组的患者行阴道镜下宫颈活组织检查。以病理学诊断结果为金标准,比较Cervista技术与Hybri Ma技术诊断宫颈上皮内瘤变2级或2级以上(CIN2+)的敏感度、特异度及ROC曲线。结果:在入组的288例患者中,Cervista技术和Hybri Ma技术检出高危型HPV的阳性率分别为49.31%和51.39%(P>0.05),其诊断CIN2+的敏感度分别为95.65%和91.30%(P>0.05),特异度分别为59.50%和56.20%(P>0.05),阳性预计值分别为30.99%和28.38%(P>0.05),阴性预计值分别为98.63%和97.14%(P>0.05)。两组ROC曲线下面积分别为0.776和0.738(P>0.05)。结论:Cervista技术与Hybri Ma技术诊断CIN2+的临床价值相当。
Objective: To compare the diagnostic value of Cervista and Hybri Ma for diagnosis of cervical intraepithelial neoplasia grade 2 or higher (CIN2 +) by high-risk human papillomavirus (HR-HPV) The clinical value. METHODS: A total of 288 patients with cervical cytology between the ages of 20 and 65 years who did not have definite clinical significance were enrolled in the randomized study of 288 cases of neo-Bo-based cytology in the gynecology clinic of the First Affiliated Hospital of Harbin Medical University from March 2012 to January 2013 Patients with typical squamous cells (ASCUS) underwent high-risk HPV testing using Cervista technology with Hybri Ma technology and colposcopic cervical biopsy in the enrolled patients. The sensitivity, specificity and ROC curve of Cervista technique and Hybri Ma technique in diagnosing cervical intraepithelial neoplasia grade 2 or above (CIN2 +) were compared with pathological diagnosis as the gold standard. Results: Among the 288 patients enrolled, the positive rates of HPV infection detected by Cervista and Hybri Ma were 49.31% and 51.39%, respectively (P> 0.05). The sensitivity of CIN2 + was 95.65% and 91.30 (P> 0.05). The specificities were respectively 59.50% and 56.20% (P> 0.05). The positive predictive value were 30.99% and 28.38%, respectively. The negative predictive values were 98.63% and 97.14% respectively > 0.05). The area under the ROC curve of the two groups were 0.776 and 0.738 (P> 0.05). Conclusions: The clinical value of Cervista and Hybri Ma in the diagnosis of CIN2 + is comparable.