Division of Cancer Epidemiology, McGill University, Montréal, Québec, Canada.
Centre de Recherche du Centre hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
Cancer Epidemiol Biomarkers Prev. 2022 Apr 1;31(4):851-857. doi: 10.1158/1055-9965.EPI-21-1082.
Among women whose cervical specimens tested positive for high-risk human papillomaviruses (hrHPV) via the Hybrid Capture 2 assay in the Canadian Cervical Cancer Screening Trial (CCCaST), we assessed hrHPV genotype concordance between BD Onclarity HPV Assay and Roche's Linear Array, overall and stratified by hrHPV viral load. We also evaluated the performance of cytology, cytology combined with hrHPV genotyping (Onclarity assay) for HPV16/18 and non-HPV16/18 types, and hrHPV genotyping triage strategies for the detection of cervical intraepithelial neoplasia grade 2 or 3 and worse (CIN2+/CIN3+).
Standard measures (expected agreement, agreement, and κ values) were used to compare Onclarity to the reference test, Linear Array. Twenty-four triage strategies were evaluated by calculating their sensitivities, specificities, and positive and negative predictive values for CIN2+ and CIN3+ detection.
Among 734 hrHPV+ samples tested, there was near perfect concordance irrespective of viral load between the Onclarity and Linear Array assays for the individual genotypes [human papillomaviruses (HPV) 16, 18, 31, 45, 51, 52] by Onclarity (κ values ranged from 0.92-0.98). Strategies with adequate specificity (>75%) and the highest sensitivities to detect CIN3+ among 617 women positive for hrHPV, were positivity to HPV16 and/or 31 (Sensitivity: 65.2%, Specificity: 76.9%) and HPV16 and/or 18 (Sensitivity: 58.7%, Specificity: 81.6%).
While confirming the importance of HPV16, we found that HPV31 was comparable with HPV18 for the detection of CIN2/3+ in the triage of women positive for hrHPV.
HPV31 may be an important genotype in the triage of women positive for hrHPV.
在加拿大宫颈癌筛查试验（CCCaST）中，通过杂交捕获 2 检测法（Hybrid Capture 2 assay）检测到宫颈标本中高危型人乳头瘤病毒（hrHPV）阳性的女性中，我们评估了 BD Onclarity HPV 检测法和罗氏公司 Linear Array 之间的 hrHPV 基因型一致性，总体上以及按 hrHPV 病毒载量分层。我们还评估了细胞学、细胞学联合 hrHPV 基因分型（Onclarity 检测法）检测 HPV16/18 型和非 HPV16/18 型以及用于检测宫颈上皮内瘤变 2 级或 3 级及更高级别（CIN2+/CIN3+）的 hrHPV 基因分型分流策略的性能。
使用标准指标（预期一致性、一致性和κ 值）比较 Onclarity 与参考检测方法 Linear Array。通过计算其对检测 CIN2+和 CIN3+的敏感性、特异性以及阳性和阴性预测值，评估了 24 种分流策略。
在 734 例 hrHPV+样本中，无论病毒载量如何，Onclarity 与 Linear Array 检测法对个别基因型[人乳头瘤病毒（HPV）16、18、31、45、51、52]的一致性近乎完美（κ 值范围为 0.92-0.98）。在 617 例 hrHPV 阳性女性中，具有足够高的特异性（>75%）和最高的 CIN3+检测敏感性的策略是 HPV16 和/或 31（敏感性：65.2%，特异性：76.9%）和 HPV16 和/或 18（敏感性：58.7%，特异性：81.6%）阳性。
在确认 HPV16 重要性的同时，我们发现 HPV31 在检测 hrHPV 阳性女性的 CIN2/3+时与 HPV18 相当。
HPV31 可能是 hrHPV 阳性女性分流中的重要基因型。
