Evaluation the triage performance of p16/Ki-67 dual staining for HR-HPV positive women
10.3760/cma.j.issn.0253-9624.2020.02.015
- VernacularTitle: p16/Ki-67双染监测在高危型人乳头瘤病毒阳性人群中的分流效果评价
- Author:
Manman JIA
1
;
Dongmei ZHAO
2
;
Zhen GUO
3
;
Zeni WU
4
;
Peipei CHEN
5
;
Peipei GUO
6
;
Xingyuan SUN
5
;
Shaokai ZHANG
5
Author Information
1. Department of Gynecological Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China
2. Department of Pathology, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China
3. Central Laboratory, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China
4. Department of Cancer Epidemiology, National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
5. Department of Cancer Epidemiology, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China
6. Department of Reproductive Medicine, the Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, China
- Publication Type:Journal Article
- Keywords:
Cervical intraepithelial neoplasia;
Ervix Uteri;
HR-HPV positive;
p16/Ki-67 dual staining;
Experiment study
- From:
Chinese Journal of Preventive Medicine
2020;54(2):192-197
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women.
Method:Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared.
Results:A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95%CI: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95%CI: 61.81%-79.67%), 86.96% (95%CI:81.69%-90.88%) and 77.27% (95%CI: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95%CI: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95%CI: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95%CI: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95%CI: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing.
Conclusion:p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.
