Aptima Human Papillomavirus E6/E7 mRNA Test Results Strongly Associated with Risk for High-Grade Cervical Lesions in Follow-Up Biopsies

Objective Human papillomavirus (HPV) tests and genotyping (GT) have been used in clinical risk assessment. The purpose of this study was to analyze the performance of 2 common HPV testing platforms in risk evaluation for high-grade cervical lesions. Materials and Methods Between January 1, 2015, and December 31, 2016, a total of 4,562 Pap tests with follow-up biopsies in our laboratory database were analyzed along with HPV tests performed on Cobas (CHPV, n = 3,959) or Aptima (AHPV, n = 603) platforms. Results The sensitivity for biopsy-confirmed HSIL or worse lesions was 97% for both CHPV and AHPV (p =.75). AHPV showed significantly lower positive rates than CHPV in benign (56% vs 86%) or LSIL (66% vs 90%) biopsies, resulting in significantly higher specificity for HSIL or worse than CHPV (38% vs 12%, p <.001). AHPV demonstrated significantly higher positive predictive value for HSIL or worse (24% vs 16%, p <.001) and overall accuracy (48% vs 24%, p <.001) than CHPV. AHPV GT also had significantly higher specificity for biopsy-confirmed HSIL or worse than CHPV (88% vs 72%, p <.001) with comparable sensitivity (50% vs 51%, p =.75). Women with HPV 16 on AHPV were significantly more likely to have HSIL or worse on biopsies than those with HPV 16 on CHPV (likelihood ratio = 4.3 vs 2.0, p =.004). Conclusions Although both AHPV and CHPV were highly sensitive for biopsy-confirmed HSIL or worse lesions, AHPV and GT demonstrated significantly higher specificity and positive predictive value than CHPV. The difference is probably related to E6/E7 overexpression after viral DNA integration in high-grade lesions. The significantly higher specificity and overall accuracy of AHPV and GT for HSIL or worse lesions may be useful in clinical risk management.