The Abbott RealTime High Risk HPV test: comparative evaluation of analytical specificity and clinical sensitivity for cervical carcinoma and CIN 3 lesions with the Hybrid Capture 2 HPV DNA test.

BACKGROUND The Abbott RealTime High Risk HPV test (RealTime) is a novel assay designed to detect 14 high-risk human papillomavirus genotypes (hr-HPV) and concurrently distinguish HPV-16 and HPV-18 from other hr-HPV within a single test. OBJECTIVE To evaluate analytical specificity and clinical sensitivity for cervical carcinoma and cervical intraepithelial neoplasia grade 3 (CIN3) of the RealTime test in comparison with the Digene Hybrid Capture II Test (hc2). MATERIALS AND METHODS Analytical specificity of the RealTime assay was evaluated on 37 samples with previously determined hc2 false-positive results due to cross-reactivity of the hc2 high-risk probe cocktail with untargeted low-risk HPV genotypes. All 37 samples were negative for 14 hr-HPV using the RealTime test. Clinical sensitivity of RealTime was evaluated in comparison to hc2 on 95 and 267 archived routine cervical specimens collected from women with histologically confirmed cervical carcinoma and CIN3 lesions, respectively. Archived specimens were selected for the present study after linkage with the Slovenian national registry of CIN3 and cervical cancer to obtain histology data. RESULTS Concordant results between RealTime and hc2 were obtained in 90/95 cervical cancer samples (94.7% agreement) and in 250/267 CIN3 samples (93.6% agreement). Clinical sensitivity of RealTime and hc2 for cervical cancer in the total study cohort was 88.4% (95% confidence interval (CI): 80.3-93.6%) and 87.3% (95% CI: 79.0-92.8%), respectively, and analytical sensitivity for samples containing at least one targeted hr-HPV was 98.8% (95% CI: 93.0-100.0%) and 95.3% (95% CI: 88.2-98.5%), respectively. Clinical sensitivity of RealTime and hc2 for CIN3 lesions of the total study cohort was 91.8% (95% CI: 87.8-94.5%) and 89.1% (95% CI: 84.8-92.3%), respectively, and analytical sensitivity for samples containing at least one targeted hr-HPV was 96.4% (95% CI: 93.3-98.2%) and 92.5% (95% CI: 88.5-95.2%), respectively. CONCLUSION The RealTime test showed excellent analytical specificity and no cross-reactivity with low risk HPV genotypes that tested positive with hc2. Clinical sensitivity of the RealTime assay using archived routine cervical specimens was comparable to hc2. The RealTime test is an important new method applicable to cervical carcinoma screening and management of cervical precancerous lesions.