Division of Laboratory Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Department of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
J Low Genit Tract Dis. 2021 Jul 1;25(3):216-220. doi: 10.1097/LGT.0000000000000613.
Diagnosis of HPV infection is usually performed from cervical liquid-based cytology specimens (LBC), but these often contain a large amount of human papillomavirus (HPV) genotypes, most of which might cause transient infections. The aim of the study was to evaluate the performance of BD Onclarity HPV test genotyping method on formalin-fixed, paraffin-embedded (FFPE) cervical specimens compared with genotyping results from LBC.
Formalin-fixed, paraffin-embedded specimens from women surgically treated for cervical intraepithelial lesions (CINs) at the European Institute of Oncology, Milan, from September 2012 to June 2013 were retrieved from the archives of the Department of Pathology of the European Institute of Oncology. The FFPE and LBC specimens were genotyped using the same extended genotyping Onclarity assay.
We collected 99 samples (26 CIN 1, 30 CIN 2, and 43 CIN 3+), but 15 were excluded from the analysis: these 84 samples show an overall agreement of 89% for HPV status between FFPE Onclarity samples versus LBC samples. The FFPE and LBC samples showed identical genotype in 75% samples, compatible genotype (at least 1 of the genotypes detected in LBC sample was found in the tissue sample) in 14% specimens, and discrepant genotype in 11% samples.
Our data demonstrate a very good concordance between HPV genotypes found in cytological and tissue samples, suggesting that the Onclarity method could also be used to detect HPV in tissue samples and that the HPV genotype detected in FFPE samples is one of the HPV detected in cytological samples, supporting the thesis that one lesion is caused by one HPV genotype.
HPV 感染的诊断通常是从宫颈液基细胞学标本（LBC）进行的，但这些标本通常含有大量的人乳头瘤病毒（HPV）基因型，其中大多数可能导致一过性感染。本研究旨在评估 BD Onclarity HPV 检测基因分型方法在福尔马林固定、石蜡包埋（FFPE）宫颈标本中的性能，与 LBC 的基因分型结果进行比较。
从 2012 年 9 月至 2013 年 6 月在米兰欧洲肿瘤研究所接受宫颈上皮内病变（CIN）手术治疗的女性的 FFPE 标本中，从欧洲肿瘤研究所病理学系的档案中检索到 FFPE 标本。使用相同的扩展基因分型 Onclarity 检测方法对 FFPE 和 LBC 标本进行基因分型。
我们收集了 99 例标本（26 例 CIN1、30 例 CIN2 和 43 例 CIN3+），但有 15 例被排除在分析之外：这 84 例标本显示 FFPE Onclarity 样本与 LBC 样本之间 HPV 状态的总体一致性为 89%。FFPE 和 LBC 样本在 75%的样本中显示出相同的基因型，在 14%的标本中显示出相容的基因型（在 LBC 样本中检测到的至少 1 种基因型在组织样本中发现），在 11%的样本中显示出不同的基因型。
我们的数据表明，细胞学和组织样本中 HPV 基因型之间存在非常好的一致性，表明 Onclarity 方法也可用于检测组织样本中的 HPV，并且 FFPE 样本中检测到的 HPV 基因型是在细胞学样本中检测到的 HPV 基因型之一，支持一个病变由一种 HPV 基因型引起的假说。
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