Expanding access to cervical cancer screening: The performance of self-sampled urine HPV testing.

OBJECTIVE

Cervical cancer remains a significant public health issue, particularly in low- and middle-income countries, where access to effective screening is limited. Urine-based human papillomavirus (HPV) testing, when combined with advanced DNA purification and concentration technologies, offers a promising alternative to traditional provider-collected cervical samples for HPV detection and cervical cancer screening.

METHODS

This study evaluated the performance of a urine-based HPV test utilizing DNA purification and concentration technology (the Experimental Test) in comparison to the Cobas4800 HPV test performed on provider-collected endocervical samples (the Control Test). A total of 1280 women, primarily those testing positive for high-risk HPV (HR-HPV) and with available pathology diagnoses, were included in the analysis. Concordance between the two tests was assessed for HPV-16, HPV-18, and a pooled group of 12 HR-HPV types. Sensitivity and specificity for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) were also compared.

RESULTS

The Experimental Test demonstrated good concordance with the Control Test for detecting HPV-16 and HPV-18 (Cohen's Kappa 0.73 and 0.66 respectively), and moderate concordance for detecting the pooled 12 HR-HPV types (Kappa 0.53). In disease outcome analysis, the Experimental Test showed comparable to the Control test in term of the sensitivities in detecting CIN2+ and CIN3+ cases, but its relevant specificities are comparatively lower. Overall, the Experimental Test was noninferior to the Control Test in detecting HPV-16, HPV-18, the pooled 12 HR-HPV types, CIN2+, and CIN3+.

CONCLUSION

Urine-based HPV testing using a DNA purification and concentration process is noninferior to the gold standard Cobas4800 test on provider-collected samples for the detection of high-risk HPV types and the high grades of cervical precancerous lesions. The Experimental Test provides a highly sensitive, reliable, and scalable option for cervical cancer screening, particularly in settings where traditional screening methods are less accessible.