Department of Pathology, Medeniyet University Goztepe Training and Research Hospital, Istanbul, Turkey
Department of Pathology, Medeniyet University Goztepe Training and Research Hospital, Istanbul, Turkey.
J Clin Pathol. 2023 Jan;76(1):40-46. doi: 10.1136/jclinpath-2021-207657. Epub 2021 Aug 10.
There are many scenarios where high-risk human papillomavirus (HPV) detection in formalin-fixed paraffin-embedded (FFPE) specimens is important. However, there is no Food and Drug Administration (FDA)-approved and clinically validated technique for detecting high-risk HPV in FFPE tissues. In this study, we evaluated two commercially available HPV assays which are FDA-approved for use on cytology specimens, the Aptima HPV assay and the Beckton Dickinson (BD) Onclarity assay, to detect high-risk HPV in FFPE tissues of cervical high-grade squamous intraepithelial lesion (HSIL) and squamous cell carcinoma (SCC).
A total of 189 cases (46 SCC, 107 HSIL and 36 benign/normal) were tested for high-risk HPV with the Aptima HPV assay and a subset of cases (n=97) with the BD Onclarity assay.
The sensitivities of the Aptima and BD Onclarity HPV assays were 99.4% (95% CI 96.46% to 99.98%) and 75.9% (95% CI 65.27% to 84.62%), respectively; the specificity and positive predictive value (PPV) of the two assays were 100%. Negative predictive values of the Aptima and BD Onclarity HPV assays were 97.3% (95% CI 83.61% to 99.61%) and 67.7% (95% CI 58.91% to 75.47%), respectively. The kappa value (0.96) for comparison of the distribution of high-risk HPV types between the two assays was high. HPV 16 was the most common high-risk HPV type for HSIL and SCC cases. However, SCC cases had higher percentages of HPV 16 and HPV 18/45 and lower percentages of other high-risk HPV types compared with HSIL cases.
Both assays are reliable methods for high-risk HPV detection and genotype determination in FFPE specimens, with high PPV and specificity. The Aptima HPV assay has the advantage of higher sensitivity. As far as we are aware, this is the first study comparing the Aptima HPV assay and the BD Onclarity assay in FFPE tissues. Our study results should be tested and confirmed in larger cohorts.
在许多情况下，检测福尔马林固定石蜡包埋（FFPE）标本中的高危型人乳头瘤病毒（HPV）非常重要。然而，目前尚无经美国食品药品监督管理局（FDA）批准并经过临床验证的用于检测 FFPE 组织中高危 HPV 的技术。在这项研究中，我们评估了两种已获得 FDA 批准用于细胞学标本的市售 HPV 检测方法，即 Aptima HPV 检测法和贝克顿·迪金森（BD）Onclarity 检测法，以检测宫颈高级别鳞状上皮内病变（HSIL）和鳞状细胞癌（SCC）的 FFPE 组织中的高危 HPV。
共检测了 189 例标本（46 例 SCC、107 例 HSIL 和 36 例良性/正常），使用 Aptima HPV 检测法进行高危 HPV 检测，其中一部分（n=97）使用 BD Onclarity 检测法。
Aptima 和 BD Onclarity HPV 检测法的敏感性分别为 99.4%（95%CI 96.46%至 99.98%）和 75.9%（95%CI 65.27%至 84.62%）；两种检测方法的特异性和阳性预测值（PPV）均为 100%。Aptima 和 BD Onclarity HPV 检测法的阴性预测值分别为 97.3%（95%CI 83.61%至 99.61%）和 67.7%（95%CI 58.91%至 75.47%）。两种检测方法检测的高危 HPV 类型分布的kappa 值（0.96）较高。HPV 16 是 HSIL 和 SCC 病例中最常见的高危 HPV 类型。然而，与 HSIL 病例相比，SCC 病例中 HPV 16 和 HPV 18/45 的比例更高，而其他高危 HPV 类型的比例更低。
两种检测方法都是检测 FFPE 标本中高危 HPV 并确定 HPV 基因型的可靠方法，具有较高的 PPV 和特异性。Aptima HPV 检测法的敏感性更高。据我们所知，这是首次比较 Aptima HPV 检测法和 BD Onclarity 检测法在 FFPE 组织中的应用。我们的研究结果应在更大的队列中进行验证。
