Detection of Human Papillomavirus Genotypes Among High-Risk Women: A Comparison of Hybrid Capture and Linear Array Tests

Objectives: To assess the concordance and performance of 2 different assays in detection of human papiHomavirus genotypes among women with abnormal Pap smear. Study Design: A series of 575 women referred for colposcopy due to an abnormal Pap smear were analyzed with the Linear Array HPV Genotyping test detecting 37 HPV types and compared with Hybrid Capture II (HCII) assay for detection of carcinogenic HPV. Histologie outcomes of cervical intraepithelial neoplasia grade 2 (CIN2) or worse (CIN2+) and CIN3+ were the primary endpoints. Clinical performance, including receiver operating characteristics, was determined for both tests. Results: and linear array (LA) were concordant in 88.1% (433/491; 95% CI 85.3%-91.0%), having a substantial agreement with regular κ (κ = 0.70,95% CI 0.62-0.77) and almost perfect agreement with weighted κ (ICC = 0.82, 95% CI 0.7-0.85). In detecting CIN2+ and CIN3+, LA is 5% and 6% more sensitive but 9.5% and 8.7% less specific than HCII (area under ROC curve; P = 0.317 and P = 0.875, respectively). Conclusions: Performance of HCII and LA does not significantly differ in detecting CIN2+ or CIN3+.