两种HPV检测方法在新疆地区宫颈癌筛查中的应用效果对比

Comparative study on the application effect of two HPV detection methods in cervical cancer screening of women in Xinjiang

目的:分析并对比基于体外核酸杂交捕获原理的HPV检测技术(careHPV)和实时荧光PCR HPV检测技术(PCR HPV)在新疆地区适龄妇女宫颈癌初级筛查中的应用效果。方法:纳入2018年新疆塔城地区1943例25~64岁有性生活史的女性,收集宫颈脱落细胞标本行HPV检测(包括careHPV和PCR HPV),任一阳性者转阴道镜行病理学诊断。比较两种HPV检测技术的一致率,分析检测结果不一致HPV阳性者的HPV型别分布。以病理确诊的子宫颈上皮内瘤变2级及以上(CIN2+)病变为金标准,比较careHPV、PCR HPV(14种)和PCR HPV(18种)3种初筛方法的灵敏度、特异度、阳性预测值、阴性预测值。结果:针对14种高危HPV型别,careHPV和PCR HPV的一致率为95.16%,Kappa值为0.715。careHPV和PCR HPV检测14种高危型别均阳性妇女共126例,其中HPV 16型感染率最高,占18.25%(23例);其次是HPV 51型,占12.70%(16例);绝大多数是单一型别感染。在careHPV检测中,医生采样和自行采样组的高危型HPV阳性率分别为8.90%和9.83%,差异有统计学意义(P=0.006),而PCR HPV检测14种高危型别阳性率在两组间差异无统计学意义(P=0.144)。PCR HPV检测的灵敏度最高,为88.89(95%CI为74.37~100),其次为careHPV,其灵敏度为83.33(95%CI为66.12~100);careHPV检测的特异度和阳性预测值最高,分别为91.79%和8.67%,PCR HPV检测的阴性预测值较高。结论:careHPV检测与PCR HPV检测一致率较高,在宫颈癌初级筛查方面,两种HPV检测方法均得到了很好的效果,且两种检测方法有其不同的优势,应根据不同地区的卫生资源,适当选择检测方法,运用于筛查及临床诊断中。

Objective:To analyze and compare the application effect of HPV detection technology(careHPV)based on in vitro nucleic acid hybridization capture principle and real-time fluorescent PCR HPV detection technology(PCR HPV)in primary screening of neutron cervical cancer in women of appropriate age in Xinjiang.Methods:In 2018,a total of 1943 sexually active women aged 25~64 years were enrolled in Tacheng District,Xinjiang Province.The women were instructed to collect cervical cell samples by themselves or gynecologists for HPV detection(including careHPV and PCR HPV),and any positive women were transferred to negative endoscopy for pathological diagnosis.The consistency rate of two HPV detection techniques was compared,and the distribution of HPV types in the HPV-positive patients with inconsistent test results was analyzed.The sensitivity,specificity,positive predictive value and negative predictive value of careHPV,PCR HPV(14 kinds)and PCR HPV(18 kinds)were compared with the pathological diagnosis of grade 2 and above cervical intraepithelial neoplasia(CIN2+)as the gold standard.Results:For 14 high-risk HPV types,the agreement rate between careHPV and PCR HPV was 95.16%,and Kappa value was 0.715.A total of 126 women were tested positive for 14 high-risk types of careHPV and PCR HPV,among which type 16 infection rate was the highest,accounting for 18.25%(23 cases).Type 51 infection followed,accounting for 12.70%(16 cases).The vast majority were monotypic infections.In careHPV test,the positive rates of high-risk HPV were 8.90%and 9.83%,respectively,between the two groups sampled by doctors and self-sampled(P=0.006),while the positive rates of 14 types of high-risk HPV detected by PCR were not statistically significant between the two groups(P=0.144).The sensitivity of PCR HPV was the highest,88.89(95%CI:74.37~100),followed by careHPV,83.33(95%CI:66.12~100).Conclusion:The consistency rate between careHPV test and PCR HPV test is high.In terms of primary screening of cervical cancer,the two HPV test methods have obtained good results,and the two test methods have their different advantages.The test methods should be selected appropriately according to the health resources in different regions,and used in screening and clinical diagnosis.