The clinical performance of primary HPV screening, primary HPV screening plus cytology cotesting, and cytology alone at a tertiary care hospital.

BACKGROUND:Algorithms for primary human papillomavirus (HPV) screening, primary HPV screening plus cytology cotesting, and cytology alone were evaluated previously in large cohort trials for cervical cancer detection, although the quality of cytology in those studies was controversial. To investigate whether these 3 algorithms would be applicable in routine practice at a tertiary care hospital, the authors compared their clinical performance. In addition, the prevalence of HPV genotypes was determined. METHODS:Cervical cytology samples (n = 1000) were tested using liquid-based cytology (LBC), a nucleic acid hybridization assay, real-time polymerase chain reaction analysis, and direct HPV DNA sequencing. The clinical performance of the 3 algorithms was compared among women in different age groups (age range, 17-86 years; median age, 44.7 years). RESULTS:For cervical intraepithelial neoplasia grade 2 or worse (CIN 2+), the sensitivity of primary HPV screening alone, cotesting, and LBC alone was 71.7%, 72.5%, and 63.8%, respectively; whereas the specificity was 87.5%, 96.5%, and 97.4%, respectively. Cotesting and LBC alone had slightly higher positive predictive values for CIN 2 + (97.8% and 98.9%, respectively) than primary HPV screening alone (91%), whereas primary HPV screening alone and cotesting demonstrated higher negative predictive values (63.6% and 62.5%, respectively) than LBC alone (43.2%). High-risk HPV types were detected in 24.3% of individuals. The most common type was HPV type 16 (HPV-16) followed by multiple HPV infections and HPV-58, HPV-52, HPV-31, HPV-35, HPV-51, HPV-39, HPV-56, HPV-33, HPV-18, HPV-59, and HPV-45. CONCLUSIONS:Primary HPV screening alone in a tertiary care hospital demonstrated a performance that was equivalent to that of cotesting for CIN 2+, irrespective of patient age. With regard to the distribution of HPV genotypes, the nonavalent HPV vaccine would prevent approximately 60% of high-risk HPV.