Clinical cervical cytology specimens (n ؍ 466) collected in PreservCyt (Hologic Inc.) were used to evaluate the agreement between Hybrid Capture 2 (hc2; Qiagen) and cobas 4800 (c4800; Roche Molecular Diagnostics) for the detection of high-risk human papillomavirus (HR HPV) genotype infections. The agreement between the two assays was 93.8% (kappa ؍ 0.87; 95% confidence interval, 0.828 to 0.918), with 186 and 251 concordant positive and negative results, respectively. All 186 concordant positives were confirmed using the Linear Array (LA; Roche Molecular Diagnostics) genotyping test. Of the 29 samples with discordant results (6.2%), 18 were hc2 positive and LA verified 17 as positive for HR HPV. Eleven discordant specimens were c4800 positive, and LA confirmed 5 as positive for HR HPV. As of October 2009, practice guidelines in Alberta, Canada, recommend reflex HPV testing for women over 30 years old with atypical squamous cells of undetermined significance (ASCUS) and for women over 50 years old with low-grade squamous intraepithelial lesions (LSIL) to help prioritize those who should undergo further evaluation. In this study, agreement between hc2 and c4800 results for samples from women over 30 years old with ASCUS cytology was 92.3% (n ؍ 13), while no samples from women over 50 years old with LSIL cytology were identified for analysis.
Studies have shown that cervical cancer is a preventable disease, and its incidence and associated mortality rate have declined since the advent of Papanicolau (Pap) test screening programs (13,17). Opportunities for primary prevention and enhanced secondary prevention exist because of the understanding that human papillomaviruses (HPV) cause cervical cancer (33). To date, about 120 HPV genotypes have been classified (2); approximately 60 genotypes are known to infect the human genital tract, of which 12 genotypes (HPV 16,18,31,33, 35, 39, 45, 51, 52, 56, 58, and 59) are considered oncogenic or high risk (HR) and 5 genotypes (HPV 26, 53, 66, 68, and 72) are considered possibly oncogenic as their significance in cervical cancer incidence is unclear (21, 26). Persistent HR HPV infection is a requirement for progression from squamous intraepithelial lesions (SIL) to cervical intraepithelial neoplasia (CIN) and finally cervical cancer (7,10,16,27,30). Studies worldwide have shown that HPV 16 is detected most often (50 to 60%) in cervical cancer cases, followed by HPV 18 (10 to 12%) and HPV 31 and HPV 45 (4 to 5% each) (3). In the vast majority of women, HPV infections occur at a young age shortly after sexual debut and are transient. Detection of HR HPV in women over the age of 30 years is an indication that persistent infection may be occurring (7), which is necessary for the development of cervical cancer.Pap testing has limitations such as interoperator variability and low sensitivity. High-risk HPV testing (when used as either primary screening or for reflex testing following a nonnegative cytology result) improves patient management by providing a more accurate risk as...