[Performance of high-risk HPV typing test in early diagnosis of cervical cancer]

Zhonghua Yi Xue Za Zhi. 2020 May 12;100(18):1396-1400. doi: 10.3760/cma.j.cn112137-20191024-02313.
[Article in Chinese]

Abstract

Objective: To evaluate the performance of High-risk HPV typing detection in cervical cancer screening. Methods: A total of 3 231 women were recruited as the subjects of cervical cancer screening from Jiyuan city of Henan provinces from June to July 2017. All women underwent HPV DNA test. The women with cytological examination ≥ASCUS or cytological examination negative and HPV 16/18 positive underwent colposcopy biopsy and pathological examination. Pathological diagnosis was used as the gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value(NPV) as well as corresponding 95% confidence interval (CI) of HR-HPV and HPV 16/18 were calculated. Results: The mean age of 3 231 subjects selected in this study was 46.84±10.00 (21-64) years old. 524 subjects had the positive results of HR-HPV, including 91 of HPV16 and 15 of HPV18. Pathological test result CIN2+ was the gold standard. The sensitivity and specificity of HR-HPV for cervical precancer lesions screening were 93.75 (95%CI: 79.85-98.27) and 84.56% (95%CI: 83.26-85.77), respectively. To compared with HR-HPV, HPV16/18 had low sensitivity (65.63%, 95%CI: 48.31-79.59)and higher specificity (97.44%, 95%CI: 96.83-97.93). After age stratification by age 30 and 45, the sensitivity of HPV 16/18 was same with HR-HPV (100%, 95%CI: 34.24-100.00), the specificity of HPV 16/18 was higher than HR-HPV (98.71%, 95%CI: 96.27-99.56 vs 84.48%, 95%CI: 79.27-88.58) in<30 age group.The sensitivity of HR-HPVin 30-45 and ≥45 age group were higher than HPV16/18 (85.71%, 95%CI: 48.69-97.43 vs 71.43%, 95%CI: 35.89-91.78, 95.65%, 95%CI: 79.01-99.23 vs 60.87%, 95%CI: 40.79-77.84), but the specificity werelower than HPV16/18 (86.89%, 95%CI: 84.58-88.90 vs 98.51%, 95%CI: 97.51-99.11、83.49%, 95%CI: 81.81-85.04 vs 96.80%, 95%CI: 95.94-97.48). Conclusions: HR-HPV detection has relatively high sensitivity and specificity in cervical cancer screening. For >30 years old women, HR-HPV is more recommended in cervical cancer screening. Therefore, HR-HPV detection is an effective method for cervical cancer screening.

目的: 评价高危型人乳头瘤病毒(HPV)DNA分型检测在宫颈癌筛查中的效果。 方法: 选择2017年6至7月在河南省济源市招募的3 231名妇女作为宫颈癌筛查对象,所有研究对象均进行HPV DNA检测,细胞学检查结果≥ASCUS、细胞学检查结果阴性但HPV16/18阳性的受试者均进行阴道镜检查和活检。以组织病理学诊断作为金标准,计算HR-HPV和HPV16/18检测的灵敏度、特异度、阳性预测值(PPV)、阴性预测值(NPV)及其95%CI结果: 符合入选标准且纳入研究的受试者共计3 231例,其年龄为(46.84±10.00)(21~64)岁。其中HR-HPV阳性者524例,HPV16阳性者91例,HPV 18阳性者15例。以病理检测结果CIN2+为金标准,HR-HPV检测对宫颈癌筛查人群的筛查效果的灵敏度为93.75(95%CI:79.85~98.27),特异度为84.56%(95%CI:83.26~85.77),HPV16/18型别的灵敏度(65.63%,95%CI:48.31~79.59)低于HR-HPV,特异度(97.44%,95%CI:96.83~97.93)高于HR-HPV。按照年龄30岁和45岁进行分层后,HPV16/18在<30岁年龄组的灵敏度与HR-HPV一致(100%,95%CI:34.24~100.00),特异度高于HR-HPV(98.71%,95%CI:96.27~99.56比84.48%,95%CI:79.27~88.58),在30~45岁和≥45岁年龄层,HR-HPV的灵敏度高于HPV16/18(85.71%,95%CI:48.69~97.43比71.43%,95%CI:35.89~91.78、95.65%,95%CI:79.01~99.23比60.87%,95%CI:40.79~77.84),特异度低于HPV16/18(86.89%,95%CI:84.58~88.90比98.51%,95%CI:97.51~99.11、83.49%,95%CI:81.81~85.04比96.80%,95%CI:95.94~97.48)。 结论: HR-HPV检测在宫颈癌筛查人群中具有较高的灵敏度和特异度,且对于年龄>30岁女性,在宫颈癌筛查是更建议进行HR-HPV检测。因此,HR-HPV检测是人群宫颈癌筛查的有效方法。.

Keywords: Cervical cancer; Cervical precancer lesions; High risk-human papilloma virus; Human papilloma virus 16/18; Screening.

MeSH terms

  • Adult
  • Colposcopy
  • Early Detection of Cancer
  • Female
  • Human papillomavirus 16
  • Human papillomavirus 18
  • Humans
  • Middle Aged
  • Papillomaviridae*
  • Papillomavirus Infections* / complications
  • Pregnancy
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia
  • Uterine Cervical Neoplasms*
  • Young Adult