Comparison of the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay for detection of high-risk human papillomavirus in women with abnormal PAP smear

Infection with human papillomavirus (HPV) is a necessary step in the progression to cervical cancer. Many methods for HPV testing are
currently available, mostly developed to detect pools of HPV types. Hybrid Capture 2 (HC2) is one of the most widely used. A new PCR-based
assay, the Roche AMPLICOR HPV test, has been recently developed. Both assays recognize a group of 13 HR HPV types contemporaneously.
This study evaluated the performance of both methods for detecting high-grade cervical lesions as a part of management for abnormal PAP
smears. The study population was composed of 213 women, all referred to colposcopy and histologic diagnosis following an abnormal PAP test.
Biopsy-confirmed high-grade cervical intraepithelial neoplasia was used as a gold standard. Overall agreement was 84.9% with a kappa value of
0.6. When comparing the ability to detect moderate cervical intraepithelial neoplasia (CIN2+) and high-grade cervical intraepithelial neoplasia
(CIN3+/cancer), AMPLICOR proved slightly more sensitive than HC2, a finding that is important when HPV testing is used in a triage of borderline
smear results. Genotyping of discordant results showed a prevalence of LR-HPV types in HC2 positive/AMPLICOR negative samples, and a similar
prevalence of HR- and LR-HPV types in AMPLICOR positive/HC2 negative samples. In conclusion, the study shows that the AMPLICOR assay
is more sensitive than HC2, which makes it a valid alternative for routine clinical use.