High-risk human papillomavirus (HPV) detection in formalin-fixed paraffin-embedded cervical tissues: performances of Aptima HPV assay and Beckton Dickinson (BD) Onclarity assay

Abstract

AimThere 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).MethodsA 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.ResultsThe 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.ConclusionBoth 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.

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.…”

Immediate histopathologic correlation in Turkish population with negative cytology and high‐risk human papillomavirus positivity: A retrospective analysis of high‐risk human papillomavirus genotype and stratified by age

“…25 Thus, the Aptima hrHPV platform has higher specificity than other platforms in the literature. 17,22,26 The higher specificity of Aptima may have significance in a higher tissue diagnosis of ≥HSIL in the current study.…”

“…The Hybrid Capture 2 uses signal amplification technology to detect DNA–RNA hybrids and does not include any DNA amplification process 25 . Thus, the Aptima hrHPV platform has higher specificity than other platforms in the literature 17,22,26 . The higher specificity of Aptima may have significance in a higher tissue diagnosis of ≥HSIL in the current study.…”

Point-of-Care Testing for Infectious Diseases Based on Class 2 CRISPR/Cas Technology

“…HPV-6 and HPV-11 are common causes of genital warts and laryngeal papillomatosis. The current diagnostic methods of HPV include Pap smear (Papanicolaou-stain), DNA hybridization, and mRNA detection by chemiluminescent analysis or flow cytometry and qPCR [ 72 , 73 , 74 ]. DNA hybridization, mRNA detection, and qPCR are time-consuming, troublesome, and not portable.…”