Agreement between INDICAID™ HPV (human papillomavirus) Urine Test and BD Onclarity™ HPV Assay in detection of high-risk HPV in self-collected urine samples

OBJECTIVE: The objective of this investigation was to compare the novel INDICAID™ HPV (human papillomavirus) Urine Test using self-collected urine samples with the BD Onclarity™ HPV Assay using clinician-collected endocervical swabs in the detection of high-risk HPV in asymptomatic women. METHODS: Asymptomatic women aged 25 to 64 were consecutively recruited and asked to provide self-collected urine samples and clinician-collected endocervical swabs concurrently. The urine samples underwent the INDICAID™ HPV Urine Test for HPV DNA testing. The endocervical swabs were subjected to the BD Onclarity™ HPV Assay. The results of the 2 were compared. RESULTS: A total of 502 women were approached and 245 women agreed to provide paired samples. A total of 241 women were included in analysis. Cohen's Kappa values demonstrated a strong consistency between the 2 tests, with a k value of 0.887 for the detection of HPV 16 and HPV 18. The overall percent agreement showed a strong agreement between the 2 tests, with 99.6% for the detection of HPV 16 and HPV 18, and 94.5% for other high-risk HPV types. CONCLUSION: The results show that using self-collected urine to detect high-risk HPV using the INDICAID™ HPV Urine Test is comparable to using the BD Onclarity™ HPV Assay with clinician-collected vaginal samples. This demonstrates the accuracy of the novel INDICAID™ HPV Urine Test. The potential of urine-based screening as an alternative method is significant, particularly in enhancing participation in cervical cancer screening programs. This approach could be beneficial for subpopulations facing barriers to healthcare access.