Regional Cancer Prevention Laboratory - Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy.
General Laboratory - Careggi University Hospital, Florence, Italy.
J Med Screen. 2021 Dec;28(4):472-479. doi: 10.1177/0969141321992820. Epub 2021 Feb 10.
To compare, in a primary human papillomavirus screening setting, two different validated human papillomavirus tests, considering their analytical and clinical screening performances.
In Tuscany, a human papillomavirus screening program was implemented in 2013. Hybrid capture 2 (Qiagen) was used for testing until May 2016, when it was replaced by the cobas 4800 human papillomavirus test (Cobas; Roche). We evaluated the performance of Hybrid capture 2 and Cobas on: the same screening population in two different periods (before and after changing to Cobas); the same Hybrid capture 2-positive consecutive samples. Discordant samples (Hybrid capture 2-positive/Cobas negative) were typed on the L1 gene (reverse line blot, AB Analitica) and E6/E7 genes (BD Onclarity assay).
In the considered time period ( = 37,775), human papillomavirus positivity was 9.8% and 7.4%, respectively, for Hybrid capture 2 and Cobas ( < 0.0001). At immediate colposcopy, the cervical intraepithelial neoplasia, grade 2 positive predictive value was, respectively, 23.8% and 34% ( < 0.001). At one-year recall, human papillomavirus persistence was, respectively, 40.6% and 62.2% ( < 0.0001). Of Hybrid capture 2-positive re-tested samples ( = 620), 32.4% were Cobas negative. Of discordant samples typed on L1, 7% were positive for the 12 high-risk human papillomavirus. Of the samples found to be negative for the 12 high-risk human papillomavirus types on L1, 14.5% were positive on E6/E7 typing. Among the discordant samples, the only two cervical intraepithelial neoplasia (CIN) grade 3 lesions were non-high-risk human papillomavirus positive on both L1 and E6/E7 typing.
At baseline, Hybrid capture 2 showed greater human papillomavirus positivity and a lower CIN2+ positive predictive value than Cobas, which was more specific than Hybrid capture 2 in detection of high-risk human papillomavirus: 80% of discordant samples were confirmed as high-risk human papillomavirus negative. This higher analytical specificity determined the non-identification of two CIN3 lesions.
在原发性人乳头瘤病毒（HPV）筛查环境中，比较两种经过验证的 HPV 检测方法的分析和临床筛查性能。
在托斯卡纳，2013 年启动了 HPV 筛查项目。在 2016 年 5 月之前，采用杂交捕获 2（Qiagen）进行检测，之后改为 cobas 4800 HPV 检测（Cobas；罗氏）。我们评估了 Hybrid capture 2 和 Cobas 在以下方面的性能：在两个不同时期（更换为 Cobas 之前和之后）对相同的筛查人群进行检测；对相同的 Hybrid capture 2 阳性连续样本进行检测。对 Hybrid capture 2 阳性/Cobas 阴性的不一致样本（discrepant sample），采用 L1 基因（反向线印迹，AB Analitica）和 E6/E7 基因（BD Onclarity 检测）进行分型。
在所考虑的时间段内（=37775），Hybrid capture 2 和 Cobas 的 HPV 阳性率分别为 9.8%和 7.4%（<0.0001）。直接行阴道镜检查时，宫颈上皮内瘤变（CIN）2 级的阳性预测值分别为 23.8%和 34%（<0.001）。在 1 年的随访中，HPV 持续存在率分别为 40.6%和 62.2%（<0.0001）。在重新检测的 620 份 Hybrid capture 2 阳性样本中，32.4%的样本 Cobas 检测为阴性。在 L1 基因分型的不一致样本中，有 7%为 12 种高危型 HPV 阳性。在 L1 基因分型为 12 种高危型 HPV 阴性的样本中，E6/E7 基因分型阳性率为 14.5%。在不一致的样本中，仅有的 2 例 CIN3 病变在 L1 和 E6/E7 基因分型上均为非高危型 HPV 阳性。
在基线时，Hybrid capture 2 的 HPV 阳性率高于 Cobas，CIN2+的阳性预测值低于 Cobas，在检测高危型 HPV 方面，Hybrid capture 2 比 Cobas 更具特异性：80%的不一致样本被确认为高危型 HPV 阴性。这种更高的分析特异性导致了 2 例 CIN3 病变未被识别。
