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

Abstract Although urine‐based human papillomavirus (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 polymerase chain reaction (PCR)‐based HPV test (urine‐based HPV test). Two vaginal samples were tested by care HPV 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 80.5% ( κ = 0.605) between the urine‐based HPV test, care HPV test, and GenPlex® HPV genotyping assay. Against CIN2 detection, the care HPV 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 care HPV 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.