A Narrative Review of Urine-Based Human Papillomavirus Screening: Performance, Challenges, and Opportunities to Expand Access in the United States.

BACKGROUND

In the United States, about 12,000 new cases of cervical cancer are diagnosed each year, largely due to limited screening access. Urine-based testing for human papillomavirus (HPV) offers a noninvasive, self-sampling method that could improve access to screening. We conducted a narrative review of urine-based HPV testing, focusing on diagnostic performance and feasibility.

METHODS

Studies were identified through PubMed using combinations of search terms including "urine," "screening," "diagnostic tests," and "HPV" from January 1, 2006, to December 31, 2024. Studies reporting test performance for detecting HPV and acceptability of urine-based HPV testing compared with cervical specimens, vaginal specimens, or precancerous lesions were included. Weighted averages for sensitivity and specificity were calculated based on sample sizes.

RESULTS

We identified 36 studies (N = 65 to N = 1952) evaluating test performance for detecting HPV in urine specimens. When compared with cervical specimens, vaginal specimens, and CIN2+-confirmed lesions, urine-based testing demonstrated a wide range of sensitivity (44.8%-98.6%) and specificity (61%-100%). Differences in assay technology, genomic target, and clinical context contributed to the variability in findings. Regarding acceptability (n = 10 studies), studies found participants to be comfortable with urine sampling due to its ease of collection.

CONCLUSIONS

Urine-based HPV testing is widely accepted but requires further standardization to improve performance and secure Food and Drug Administration approval for broader implementation.