The use of clinically validated human papillomavirus (HPV) assays is recommended in cervical cancer screening, and extended genotyping is getting attention as a triage biomarker because of the different oncogenic risk of the high-risk HPV genotypes. We compared the results of the Becton & Dickinson (BD) Onclarity HPV assay, on the residual baseline cervico-vaginal specimens of the NTCC2 trial, to those of the screening HPV-DNA assay (Cobas 4800 or HC2) and to cytology, p16/ki67 and E6/E7 mRNA triage results. We genotyped virtually all HPV-positive women and a consecutive sample of HPV-negatives. Among the 3,129 baseline-positives, 75.5% (k = 0.368) were BD-positive, as were 5 of the 333 baseline-negatives (1.5%). The concordance between BD and HPV-DNA screening test was 87% for Cobas (1,250/1,436) and 65.9% for HC2 (1,115/1,693). A higher than the recommended positivity threshold for Onclarity would increase the agreement but would not improve concordance in the overall screening population. Among the baseline-positive cases, we observed an increasing trend of BD positivity with cytology severity (from 71.6% in negative for intraepithelial lesion of malignancy to 95.1% in ASC-H+ samples), with histologically confirmed CIN3 (96.9%), with p16/ki67 dual staining positivity (90.9% among the positive and 69.6% among the negative specimens), and with E6/E7 mRNA positivity (93.4% in the mRNA-positive cases vs 39.7% among the mRNA-negatives). Our findings confirm some disagreement among different HPV assays used for screening. Nevertheless, the agreement is substantial for women with high-grade cytology, histologically confirmed CIN3, and p16/ki67 or mRNA positivity at triage, thus confirming a good clinical performance of all the tests used.
Extended HPV genotyping by the BD Onclarity assay: concordance with screening HPV-DNA assays, triage biomarkers, and histopathology in women from the NTCC2 study / De Marco, L.; Bisanzi, S.; Ronco, G.; Mancuso, P.; Carozzi, F.; Allia, E.; Rizzolo, R.; Gustinucci, D.; Viti, J.; Iossa, A.; Cesarini, E.; Bulletti, S.; Passamonti, B.; Gori, S.; Toniolo, L.; Mistro, A. D.; Rossi, P. G.; Benevolo, M.; Barca, A.; Quadrino, F.; Benevolo, M.; Rollo, F.; Rossi, P. G.; Mancuso, P.; Venturelli, F.; Bonvicini, L.; Carlinfante, G.; Rubino, T.; Carozzi, F. M.; Bisanzi, S.; Confortini, M.; Di Pierro, C.; Fantacci, G.; Iossa, A.; Mongia, A.; Sani, C.; Pompeo, G.; Puliti, D.; Andersson, K. L.; Viti, J.; Baldini, A.; Ronco, G.; De Marco, L.; Allia, E.; Rizzolo, R.; Macri, L.; Tos, A. G.; Pusiol, T.; Barbareschi, M.; Bragantini, E.; Passamonti, B.; Gustinucci, D.; Bulletti, S.; Cesarini, E.; Giaimo, M. D.; Penon, G.; Bertazzo, A.; Toniolo, L.; Farruggio, A.; Marchi, N.; Del Mistro, A.; Frayle, H.; Gori, S.; Zorzi, M.; Narne, E.; Turrin, A.. - In: MICROBIOLOGY SPECTRUM. - ISSN 2165-0497. - 13:1(2025), pp. 0-0. [10.1128/spectrum.00897-24]
Extended HPV genotyping by the BD Onclarity assay: concordance with screening HPV-DNA assays, triage biomarkers, and histopathology in women from the NTCC2 study
Venturelli F.;
2025
Abstract
The use of clinically validated human papillomavirus (HPV) assays is recommended in cervical cancer screening, and extended genotyping is getting attention as a triage biomarker because of the different oncogenic risk of the high-risk HPV genotypes. We compared the results of the Becton & Dickinson (BD) Onclarity HPV assay, on the residual baseline cervico-vaginal specimens of the NTCC2 trial, to those of the screening HPV-DNA assay (Cobas 4800 or HC2) and to cytology, p16/ki67 and E6/E7 mRNA triage results. We genotyped virtually all HPV-positive women and a consecutive sample of HPV-negatives. Among the 3,129 baseline-positives, 75.5% (k = 0.368) were BD-positive, as were 5 of the 333 baseline-negatives (1.5%). The concordance between BD and HPV-DNA screening test was 87% for Cobas (1,250/1,436) and 65.9% for HC2 (1,115/1,693). A higher than the recommended positivity threshold for Onclarity would increase the agreement but would not improve concordance in the overall screening population. Among the baseline-positive cases, we observed an increasing trend of BD positivity with cytology severity (from 71.6% in negative for intraepithelial lesion of malignancy to 95.1% in ASC-H+ samples), with histologically confirmed CIN3 (96.9%), with p16/ki67 dual staining positivity (90.9% among the positive and 69.6% among the negative specimens), and with E6/E7 mRNA positivity (93.4% in the mRNA-positive cases vs 39.7% among the mRNA-negatives). Our findings confirm some disagreement among different HPV assays used for screening. Nevertheless, the agreement is substantial for women with high-grade cytology, histologically confirmed CIN3, and p16/ki67 or mRNA positivity at triage, thus confirming a good clinical performance of all the tests used.File | Dimensione | Formato | |
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