J Gynecol Oncol.  2014 Oct;25(4):287-292. 10.3802/jgo.2014.25.4.287.

The clinical performance of APTIMA human papillomavirus and Hybrid Capture 2 assays in the triage of lesser abnormal cervical cytologies

• Guo Y
• You K
• Geng L
• Qiao J

• KMID: 2130116
• DOI: http://doi.org/10.3802/jgo.2014.25.4.287

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.

Keyword

Early detection of cancer; Human Papillomavirus; Triage; Uterine cervical dysplasia; Uterine cervical neoplasms

MeSH Terms

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