Comparative performance of first-void urine and self-collected vaginal swabs against clinician-collected cervical samples using 2 HPV real-time assays in Indian women.

Abstract

Objective: To enhance participation of women in cervical cancer (CC) screening, we compared high-risk human papillomavirus (HR-HPV) DNA testing of first-void urine (FVU) and self-collected vaginal swabs (SCVSs) to the gold standard clinician collected cervical specimens (CCCSs).

Methods: In this cross-sectional study, consecutive consenting women (n=295) identified for CC screening mainly from Gynaecology-Oncology out-patient clinics were enrolled from May to October 2024. All were educated to provide self-samples (FVU, SCVS) followed by CCCS. All samples were tested for HR-HPV by 2 real-time polymerase chain reaction assays: Alinity m HR-HPV assay and Allplex™ II HPV HR assay. Awareness of CC, its screening, prevention and acceptability of self-sampling methods were assessed through a questionnaire.

Results: All sample types showed identical concordance (93.9%)/discordance (6.1%) across both real-time assays. Using Alinity m, sensitivity and specificity of FVU vs. CCCS was similar to SCVS vs. CCCS, i.e., 83.3% (95% confidence interval [CI]=68.64%-93.03%) and 98% (95% CI=95.45%-99.36%) respectively. With Allplex, sensitivity and specificity of FVU vs. CCCS was 84.78% (95% CI=71.13%-93.66%) and 97.19% (95% CI=94.29%-98.86%) respectively; and that of SCVS vs. CCCS was 97.83% (95% CI=88.47%-99.94%) and 95.98% (95% CI=92.74%-98.06%) respectively. Majority were unaware of CC (86.4%), its screening (98.6%) or its prevention (96.9%). Majority of women (92%) preferred FVU for CC if screened at regular intervals.

Conclusion: This study shows a favorable performance of FVU and SCVS in both assays. FVU is a scalable, non-invasive, acceptable and feasible alternative to CCCS, with the potential to intensify CC screening programs in low- and middle-income countries.