ArticleFrontiers in oncology2026
Clinical value of first-morning urine exfoliated cell HPV detection in the diagnosis of high-grade cervical lesions.
Article in Frontiers in oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Methods: This multicenter, cross-sectional diagnostic accuracy study enrolled 500 women attending gynaecology and colposcopy clinics at four institutions in Ningxia, China (June 2025-January 2026), using a disease-enriched design with predefined histopathological groups. All participants simultaneously underwent FMU HPV testing and cervical co-testing (liquid-based cytology [TCT] + HPV DNA). Those with abnormal co-testing underwent colposcopy and biopsy. Groups were defined histopathologically: cervical cancer (n=80), high-grade lesion/CIN2-3 (n=120), low-grade lesion/CIN1 (n=50), and no lesion (n=250). Results: FMU HPV detection rates were 96.25%, 86.67%, 58.00%, and 28.00% in the four groups (P<0.001). For CIN2+, FMU achieved sensitivity 90.50%, specificity 67.00%, PPV 64.64%, NPV 91.36%; traditional cervical testing achieved 93.00%, 64.67%, 63.70%, and 93.27%, with no significant differences (all P>0.05; no predefined non-inferiority margin was tested). Per-protocol compliance (97.20% vs 84.80%) and satisfaction (95.40% vs 79.60%) favoured FMU testing (both P<0.001); the compliance advantage persisted in an intention-to-treat analysis (76.2% vs 66.5%, P<0.001). Conclusions: In this disease-enriched diagnostic cohort, FMU HPV testing showed diagnostic performance comparable to that of traditional cervical HPV testing for CIN2+ detection, with no predefined non-inferiority margin tested, and offered substantially superior patient acceptability. These findings support FMU HPV testing as a promising complementary, non-invasive option that warrants validation in average-risk screening populations before routine implementation.
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