Benchmarking high-risk human papillomavirus testing against cytology and biopsy results in the detection of cervical dysplasia to inform clinical screening guidelines.

INTRODUCTION: The United States Preventive Services Task Force (USPSTF) recommendation for cervical cancer screening includes the option to screen with high-risk human papilloma virus (hrHPV) alone, but some studies have reported that hrHPV testing alone missed precancerous and cancerous lesions. In this study, we evaluated the test performance characteristics of hrHPV in detecting cervical dysplasia with cervical cytology and biopsy as comparators.

MATERIALS AND METHODS: We conducted a retrospective analysis of Papanicolaou smears between January and December 2019 performed at our institution with concurrent hrHPV and cytology testing. Cases were identified in the laboratory information system and abstracted data included patient age, hrHPV result, concurrent cytology result, and follow-up cervical biopsy result where available.

RESULTS: A total of 3748 cases were identified with concurrent hrHPV and cytology testing and 79 cases with concurrent hrHPV and biopsy results. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) "hrHPV for detecting dysplasia on cytology was 70% (95% CI: 60.7%-77.8%), 98% (95% CI: 97.4%-98.4%), 53% (95% CI: 46.2%-58.8%), and 99% (95% 98.7%-99.2%), respectively (P value <0.00001). The sensitivity, specificity, PPV, and NPV of hrHPV for detecting dysplasia on biopsy was 76% (95% CI: 61.1%-86.7%), 30% (95% CI: 14.7%-49.4%), 64% (95% CI: 57.0%-70.5%), and 43% (95% CI: 46.6%-61.0%), respectively (P value <0.3).

CONCLUSIONS: hrHPV testing alone would have missed 30% of dysplastic samples identified by cytology and 24% of dysplastic samples confirmed by cervical biopsy. These findings support a comprehensive strategy of dual cervical cancer screening with cytology and hrHPV testing.