Expanding access to cervical cancer screening: The performance of self-sampled urine HPV testing
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. 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. 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+. 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.
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Funding
Shenzhen Science and Technology Innovation Program Grant GJHZ20210705142543018Shenzhen Science and Technology Innovation Program Grant JCYJ20220531094012027Shenzhen Science and Technology Innovation Program Grant JCYJ20220818102811025National Key Research and Development Program of China Grant 2024YFC2707503Basic and Applied Basic Research Foundation of Guangdong Province Grant 2023A1515220137