The clinical performance of APTIMA human papillomavirus and Hybrid Capture 2 assays in the triage of lesser abnormal cervical cytologies.
10.3802/jgo.2014.25.4.287
- Author:
Yanli GUO
1
;
Ke YOU
;
Li GENG
;
Jie QIAO
Author Information
1. Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China. gengli57@163.com
- Publication Type:Original Article ; Comparative Study ; Evaluation Studies
- Keywords:
Early detection of cancer;
Human Papillomavirus;
Triage;
Uterine cervical dysplasia;
Uterine cervical neoplasms
- MeSH:
Adult;
Aged;
Cervical Intraepithelial Neoplasia/*diagnosis/epidemiology/virology;
China/epidemiology;
Colposcopy/methods;
Early Detection of Cancer/methods;
False Negative Reactions;
Female;
Human Papillomavirus DNA Tests/*methods;
Humans;
Middle Aged;
Papillomavirus Infections/complications/*diagnosis/epidemiology;
Prevalence;
Sensitivity and Specificity;
Triage;
Uterine Cervical Neoplasms/*diagnosis/epidemiology/virology;
Young Adult
- From:Journal of Gynecologic Oncology
2014;25(4):287-292
- CountryRepublic of Korea
- Language:English
-
Abstract:
OBJECTIVE: This study was performed to evaluate the clinical performance of APTIMA human papillomavirus (AHPV) assay and Hybrid Capture 2 (HC2) assay in screening for cervical disease, especially in women with atypical squamous cell of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL). METHODS: A total of 411 women diagnosed with ASC-US or LSIL were referred and further triaged by HC2 test. Prior to colposcopy, liquid-based cytology specimens were collected for the AHPV assay. Sensitivity and specificity were established based on the histological findings of cervical intraepithelial neoplasia (CIN). RESULTS: In all 411 subjects, the positive detection rate of AHPV assay was 70.8% (95% confidence interval [CI], 66.4 to 75.2), which was significantly lower than the positive detection rate of 94.9% obtained using HC2 test (95% CI, 92.3 to 96.8). Only one CIN 3-positive case was detected among the 120 AHPV-negative women, which was then confirmed by Pap smear test to be LSIL. The sensitivities of AHPV and HC2 for CIN 3 were similar (94.1% and 100%, respectively). However, AHPV showed a significantly higher specificity than HC2 test (30.2% and 5.3%, respectively; p<0.001). CONCLUSION: AHPV assay is effective in identifying CIN 3-positive cases because of its high specificity and lower false-negative rate. The use of AHPV for the triage of ASC-US and LSIL might help to reduce the referral rate of colposcopy during cervical cancer screening.