Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples

Abstract

AbstractThis study assessed the accuracy of hrHPV testing of BD Onclarity™ HPV (Onclarity) assay on vaginal self-collected FLOQSwab® versus cervical samples to ensure similar accuracy to detect cervical intraepithelial neoplasia. Testing was performed on two automated platforms, BD Viper™ and BD COR™, to evaluate the effect of machine and using two vaginal self-samples to analyse the influence of collection, transport, and freezing-unfreezing on the results.A cervical sample and two self-samples were collected from 300 women. The first collected vaginal and the cervical sample were tested on BD Viper™ and the second swab was frozen and subsequently tested on both automated systems. Test results on vaginal and cervical specimens were considered the index and comparator, respectively; colposcopy and histology were reference standards.Relative sensitivity for ≥CIN2 on vaginal samples analysed using the three different workflows vs the cervical sample was 1.01 (0.97-1.06), 1.01 (0.97-1.06), and 1.00 (0.95-1.05), respectively.Relative specificity resulted 0.83 (0.73-0.94), 0.76 (0.67-0.87) and 0.82 (0.73-0.92) for the 1st, 2nd self-collected sample tested on BD VIPER™ and 2nd self-collected sample tested on BD COR™.Cut-off optimization for HPV positivity defined at Ct ≤38.3 for HPV16, ≤34.2 for HPV18 and ≤31.5 for all other types showed an increased relative specificity with similar sensitivity. No significant difference was observed between self-samples tested with the two platforms and between first and second-collected swabs.Onclarity assay on FLOQSwab®using both platforms showed similar sensitivity but lower specificity to detect ≥CIN2 compared to cervical samples. By cut-off optimization, non-inferior specificity could be reached.