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目的:探索流式荧光杂交法检测高危型人乳头瘤病毒的临床价值。方法:收集山西省子宫颈癌高发区妇女的宫颈脱落细胞样本638例,应用流式荧光杂交法和第二代杂交捕获实验(Hybrid Capture(2 Assay,hc2)进行检测分型,根据病理诊断对检测结果进行评价,对该人群中高危型人乳头瘤病毒(human papillomavirus,HPV)的感染情况和型别分布进行统计学分析,并对这2种方法作一致性检验。结果:流式荧光杂交法检测的灵敏度、特异度、准确度分别为77.78%、93.59%和92.42%,阴、阳性预测值分别为98.13%和49.30%。该人群中高危型HPV的感染率为11.7%,非瘤样病变和子宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)1级(CIN1)中,HPV16和HPV52型为主要感染型别;子宫颈上皮内瘤变2级(CIN2)中,HPV16和HPV58型较为常见;子宫颈上皮内瘤变3级(CIN3)和子宫颈癌以HPV16型感染为主;HPV16、52、58型的感染率与病变进展呈正相关(P<0.01)。将流式荧光杂交法与hc2的检测结果作一致性检验:Κ=0.60。结论:流式荧光杂交法检测高危型HPV的特异度很高,灵敏度达77.78%,与hc2相比,两者的一致性较好;但还需进一步改进方法以提高检测的灵敏度,增加可分型的HPV亚型数。
Objective: To explore the clinical value of high-risk human papillomavirus (HPV) by flow cytometry (FCM). Methods: A total of 638 cases of cervical exfoliated cells were collected from women with high incidence of cervical cancer in Shanxi Province. Fluorescent hybridization and hybridization (2 Assay, hc2) were used to detect the type of cervical exfoliated cells. According to the pathological diagnosis The results were evaluated and the prevalence and type distribution of high-risk human papillomavirus (HPV) in this population were statistically analyzed and the two methods were tested for consistency.Results: The results of flow cytometry The sensitivity, specificity and accuracy of the method were 77.78%, 93.59% and 92.42%, respectively, and the positive and negative predictive values were 98.13% and 49.30%, respectively.The prevalence of high-risk HPV in this population was 11.7% HPV16 and HPV52 are the major infection types in cervical lesions and cervical intraepithelial neoplasia (CIN) level 1 (CIN1), while HPV16 and HPV58 are more common in cervical intraepithelial neoplasia grade 2 (CIN2) ; Cervical intraepithelial neoplasia grade 3 (CIN3) and cervical cancer with HPV16 infection; HPV16,52,58 infection rate and the progress of the disease was positively correlated (P <0.01) .Flow-fluorescence hybridization and hc2 The test results for consistency test: Κ = 0 .60 Conclusion: The specificity of high-risk HPV testing by flow fluorescent hybridization is very high with a sensitivity of 77.78%, which is better than that of hc2. However, further improvement is needed to improve the sensitivity of detection, Increase the number of subtypes HPV subtypes.