Onclarity Performance in Human Papillomavirus DNA Detection in Formalin-Fixed Paraffin-Embedded Cervical Samples

Abstract

ObjectivesDiagnosis 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.Materials and MethodsFormalin-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.ResultsWe 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.ConclusionsOur 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.

Detection of high-risk HPV in FFPE specimens of various tumours using the BD Onclarity™ HPV Assay

“…We had concordant results for 96% of all 75 samples analyzed, a sensitivity of 93% and a specificity of 100% in this series ( Table 3 ). This is similar to results by others [ [11] , [12] , [13] , [14] ]. The assay failed to detect HPV45 in one specimen.…”

“…Whereas robust validation guidelines exist for HPV testing on cervical cells specimens for use in screening [ 9 , 10 ] no such rules exist for HPV testing on histological specimens. A limited number of studies have described the use of the BD Onclarity™ HPV Assay on FFPE specimens [ [11] , [12] , [13] , [14] ] but none of these studies used FFPE specimens with a known HPV status, but rather compared the BD Onclarity™ HPV Assay analysis of the FFPE specimen with the HPV status of a paired cytology specimen. In addition, these four studies all focused exclusively on cervical material.…”

Human Papillomavirus Genotype Richness and the Biodiversity of Squamous and Glandular Cervical Dysplasias: A Cross-Sectional Study

“…Notably, 43% of patients with CIN3+ lesions exhibited only one HR-HPV type. The principle "one virus-one lesion" aligns consistently with findings in the existing research [29][30][31][32]. It also corresponds to the pathogenetic process of cervical carcinoma, in which HR-HPV integrates its genome and drives cellular transformation toward neoplastic development [6,29,33].…”

High Prevalence of Non-Vaccinated Oncogenic Human Papillomavirus Genotypes in High-Grade Squamous Intraepithelial Lesions of the Cervix: Thought-Provoking Results of a Detailed HPV Genotype Analysis

“…Cervical conization is an effective treatment for HSIL, however, this treatment cannot eradicate high-risk HPV; a wide range of recurrence rates of HSIL after conization (0.35–69%) was reported, hence close follow-up of the patients is crucial [ 26 , 28 , 29 ]. Unfortunately, there is no consensus regarding the optimal follow-up and frequency of control examinations of patients in the post-treatment period.…”

“…Thus, FFPE- HPV profile should be taken as the gold standard [ 22 , 23 , 24 , 25 ]. Hence, when applying cytological samples in clinical practice during the post-conization follow-up, detection of the same HPV genotypes, that was also presented in the cone specimen, could help to identify patients at higher risk of disease progression [ 26 , 27 ].…”