Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
J Clin Virol. 2024 Dec;175:105737. doi: 10.1016/j.jcv.2024.105737. Epub 2024 Oct 21.
The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated.
490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep.
The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94-1.05] and 1.00 [95 % CI 0.96-1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for <CIN2 on both self-samples was lower than on cervical samples (urine/cervical ratio = 0.91 [95 % CI 0.84-0.98]; vaginal/cervical ratio = 0.90 [95 % CI 0.84-0.98]). Cut-off optimisation improved specificity without compromising sensitivity. Median viral load values adjusted for cellularity were significantly higher in cervical samples compared to urine or vaginal self-samples, in general for all 12 high-risk HPV and in particular for HPV16, 18, 31, 33, 35, 45, 51, 58 (p < 0.05). No difference was observed in median viral loads between urine and vaginal samples.
Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.
VALHUDES 计划旨在评估 HPV 检测在使用尿液和阴道自我样本与宫颈临床医生采集样本检测宫颈前癌方面的临床准确性。在此，评估了 OncoPredict HPV 定量分型（QT）检测（OncoPredict QT）的临床性能。
490 名被转诊至阴道镜检查的女性使用 Colli-Pee 和 FLOQSwab 分别采集尿液和阴道样本。随后进行阴道镜检查，并使用 Cervex-Brush 采集宫颈样本，如果临床需要则进行活检。阴道样本干燥运输并在 5 mL eNAT 培养基中重新悬浮，而宫颈刷则立即转移到 20 mL ThinPrep 中。
当应用制造商的截止值时，OncoPredict HPV QT 检测在尿液和阴道自我样本中对 CIN2+的临床灵敏度与宫颈样本相似（比值分别为 0.99[95%CI 0.94-1.05]和 1.00[95%CI 0.96-1.04]）。当应用制造商的截止值时，在尿液和阴道自我样本中对<CIN2 的特异性均低于宫颈样本（尿液/宫颈比值=0.91[95%CI 0.84-0.98]；阴道/宫颈比值=0.90[95%CI 0.84-0.98]）。截止值优化提高了特异性而不影响灵敏度。一般来说，对于所有 12 种高危 HPV 病毒，以及 HPV16、18、31、33、35、45、51、58 等特定 HPV 病毒，调整细胞密度后的中位病毒载量值在宫颈样本中显著高于尿液或阴道自我样本（p<0.05）。尿液和阴道样本的中位病毒载量值没有差异。
经过截止值优化，OncoPredict HPV QT 检测在自我采集样本和宫颈样本上的准确性相似。
