Clinical performance of a newly developed domestic urine-based HPV test for cervical cancer screening in China.

Although urine-based HPV detection is promising in cervical cancer screening, it has not yet been well-developed. Women aged 30-65 were invited to participate in the current study to provide one urine, and two paired vaginal samples. Urine was detected by PCR-based HPV test（urine-based HPV test）. Two vaginal samples were tested by careHPV and GenPlex® HPV genotyping assay, respectively. Women with vaginal HPV positive were called back for colposcopy and biopsied if clinically indicated. The consistency was 79.0% (κ= 0.563) and 80% (κ=0.605) between the urine-based HPV test, careHPV test, and GenPlex® HPV genotyping assay. Against CIN2+ detection, the careHPV test showed 77.4% sensitivity, and 71.0% specificity, while the GenPlex® HPV genotyping assay had a sensitivity of 100% and a specificity of 58.7%. For urine-based HPV test, the corresponding rates were 96.8% and 58.7%. Moreover, no significant differences were observed between the urine-based HPV test and careHPV test(p=0.3395) and GenPlex® HPV genotyping assay (p=0.338). The newly developed urine-based HPV test demonstrated acceptable consistency and comparable clinical performance with referenced HPV tests for vaginal samples. Therefore, urine-based HPV detection could be a useful alternative for women with difficulties to access cervical cancer screening. This article is protected by copyright. All rights reserved.