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 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 80.5% (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.

Evaluation of a novel vaginal cells self‐sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability

“…Currently, there is a growing body of research focused on the use of urine as a medium for detecting HPV DNA, with several studies either underway or already commercialized. 25 , 26 , 27 , 28 , 29 , 30 While urine has been found to yield similar results to self‐collected vaginal specimens, some investigations have indicated that urine may be less sensitive than vaginal samples. 31 This discrepancy has been attributed to the lower concentration of HPV DNA in urine compared to cervical samples, necessitating the development of a highly sensitive detection method to ensure ample HPV DNA detection.…”

Urine‐based detection of HPV for cervical cancer screening: Time for standardized tests

“…Xu et al reported a newly developed urine‐based HPV test 10 . Their work demonstrates the enthusiastic efforts of researchers and clinicians to investigate and optimize the performance of urine‐based HPV screening.…”

“…For this purpose, a framework for validating HPV tests on self-samples, including urine, has been published to simplify the comparison of study results and the subsequent translation of these tests to clinical practice 9. This will give real insight on the performance of HPV detection in urine, reduce the observed variability and allow its implementation in clinical practice.Xu et al reported a newly developed urine-based HPV test 10. Their work demonstrates the enthusiastic efforts of researchers and clinicians to investigate and optimize the performance of urine-based HPV screening.…”