To evaluate the diagnostic performance of first-morning urine (FMU) HPV testing for detecting high-grade cervical lesions (CIN2+) compared to traditional cervical HPV testing, using histopathology as the reference standard.
Approach:
Study Design: A multicenter, cross-sectional diagnostic accuracy study conducted prospectively involving 500 women from four institutions in Ningxia, China, between June 2025 and January 2026.
Key Findings:
FMU HPV detection rates were 96.25% for cervical cancer, 86.67% for CIN2-3, 58.00% for CIN1, and 28.00% for no lesions (P<0.001).
For CIN2+, FMU testing showed sensitivity of 90.50%, specificity of 67.00%, positive predictive value (PPV) of 64.64%, and negative predictive value (NPV) of 91.36%.
Traditional cervical testing had sensitivity of 93.00%, specificity of 64.67%, PPV of 63.70%, and NPV of 93.27%, with no significant differences between the two methods (all P>0.05).
FMU testing demonstrated higher compliance (97.20% vs 84.80%) and satisfaction (95.40% vs 79.60%) compared to traditional testing (both P<0.001).
Interpretation:
FMU HPV testing shows comparable diagnostic performance to traditional cervical HPV testing for CIN2+ detection and offers better patient acceptability.
Limitations:
The study used a disease-enriched design, which limits the generalizability of the findings to average-risk screening populations.
No predefined non-inferiority margin was tested in the comparison of FMU and traditional cervical testing.
Conclusion:
FMU HPV testing is a promising non-invasive option for cervical cancer screening that warrants further validation in average-risk populations before routine implementation.
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