Background: The objective of this study was to describe the determinants of adequacy and positivity of the p16/Ki-67 assay in a human papillomavirus (HPV)-positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study. Methods: ThinPrep slides were immunostained for p16/Ki-67; each slide had 3 reports from different laboratories. The authors included population-related, sampling-related/staining-related, and interpretation-related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity. Results: In total, 3100 consecutive HPV-positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade ≥2 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC-US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16/Ki-67 report was associated with an ASC-US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity. Conclusions: The interpretation of p16/Ki-67 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.

Determinants of p16/Ki-67 adequacy and positivity in HPV-positive women from a screening population / Benevolo, Maria; Mancuso, Pamela; Allia, Elena; Gustinucci, Elena; Bulletti, Simonetta; Cesarini, Elena; Carozzi, Francesca; Maria, ; Confortini, Massimo; Bisanzi, Simonetta; Rubino, Teresa; Rollo, Francesca; Marchi, Natalina; Farruggio, Angelo; Pusiol, Teresa; Venturelli, Francesco; Giorgi Rossi, Paolo; Barca, Alessandra; Quadrino, Francesco; Rollo, Francesca; Bonvicini, Laura; Carlinfante, Gabriele; Carozzi, Francesca; Maria, ; Bisanzi, Simonetta; Confortini, Massimo; Di Pierro, Carmelina; Fantacci, Giulia; Iossa, Anna; Andersson, Karin Louise; Mongia, Alessandra; Rompeo, Giampaolo; Sani, Cristina; Puliti, Donella; Baldini, Andrea; Ronco, Guglielmo; Rizzolo, Raffaella; Gillio Tos, Anna; De Marco, Laura; Pusiol, Teresa; Barbareschi, Mattia; Bragantini, Emma; Passamonti, Basilio; Gustinucci, Daniela; Bulletti, Simonetta; Cesarini, Elena; Giaimo, Maria Donata; Penon, Gabriella; Farruggio, Angelo; Bertazzo, Alessandra; Toniolo, Laura; Del Mistro, Annarosa; Frayle, Helena; Gori, Silvia; Zorzi, Manuel; Narne, Elenz; Turrin, Anna. - In: CANCER CYTOPATHOLOGY. - ISSN 1934-662X. - 129:5(2021), pp. 383-393. [10.1002/cncy.22385]

Determinants of p16/Ki-67 adequacy and positivity in HPV-positive women from a screening population

Venturelli, Francesco;Barbareschi, Mattia;Bragantini, Emma;
2021-01-01

Abstract

Background: The objective of this study was to describe the determinants of adequacy and positivity of the p16/Ki-67 assay in a human papillomavirus (HPV)-positive screening population enrolled within the New Technologies for Cervical Cancer 2 (NTCC2) study. Methods: ThinPrep slides were immunostained for p16/Ki-67; each slide had 3 reports from different laboratories. The authors included population-related, sampling-related/staining-related, and interpretation-related variables in the analyses. Adequacy and positivity proportions were stratified by variables of interest. Univariate and multivariate logistic models were used to identify determinants of adequacy and positivity. Results: In total, 3100 consecutive HPV-positive cases were analyzed. Because every slide was interpreted by 3 centers, 9300 reports were obtained, including 905 (9.7%) that were inadequate and 2632 (28.3%) that were positive. The percentage of cases in which all 3 reports were inadequate increased with increasing age of the women and with inadequate cytology. The highest percentage of adequacy in all 3 reports and of cases with all 3 reports positive was observed in specimens from women who had grade ≥2 cervical intraepithelial neoplasia (CIN2+), atypical squamous cells of undetermined significance or more severe (ASC-US+) cytology, or mRNA positivity. The number of inadequate reports was significantly associated with increasing age, inadequate cytology, mRNA negativity, and scant cellularity. A positive p16/Ki-67 report was associated with an ASC-US+ result and with a positive mRNA result in cases both with and without CIN2+ but was associated with an HPV type 16 and/or 18 infection only in CIN2+ cases. The presence of CIN2+ was strongly associated with dual staining positivity. Conclusions: The interpretation of p16/Ki-67 results may be influenced by several different variables, all of which are part of the steps in the procedure, and by the characteristics of the screened population.
2021
5
Benevolo, Maria; Mancuso, Pamela; Allia, Elena; Gustinucci, Elena; Bulletti, Simonetta; Cesarini, Elena; Carozzi, Francesca; Maria, ; Confortini, Mass...espandi
Determinants of p16/Ki-67 adequacy and positivity in HPV-positive women from a screening population / Benevolo, Maria; Mancuso, Pamela; Allia, Elena; Gustinucci, Elena; Bulletti, Simonetta; Cesarini, Elena; Carozzi, Francesca; Maria, ; Confortini, Massimo; Bisanzi, Simonetta; Rubino, Teresa; Rollo, Francesca; Marchi, Natalina; Farruggio, Angelo; Pusiol, Teresa; Venturelli, Francesco; Giorgi Rossi, Paolo; Barca, Alessandra; Quadrino, Francesco; Rollo, Francesca; Bonvicini, Laura; Carlinfante, Gabriele; Carozzi, Francesca; Maria, ; Bisanzi, Simonetta; Confortini, Massimo; Di Pierro, Carmelina; Fantacci, Giulia; Iossa, Anna; Andersson, Karin Louise; Mongia, Alessandra; Rompeo, Giampaolo; Sani, Cristina; Puliti, Donella; Baldini, Andrea; Ronco, Guglielmo; Rizzolo, Raffaella; Gillio Tos, Anna; De Marco, Laura; Pusiol, Teresa; Barbareschi, Mattia; Bragantini, Emma; Passamonti, Basilio; Gustinucci, Daniela; Bulletti, Simonetta; Cesarini, Elena; Giaimo, Maria Donata; Penon, Gabriella; Farruggio, Angelo; Bertazzo, Alessandra; Toniolo, Laura; Del Mistro, Annarosa; Frayle, Helena; Gori, Silvia; Zorzi, Manuel; Narne, Elenz; Turrin, Anna. - In: CANCER CYTOPATHOLOGY. - ISSN 1934-662X. - 129:5(2021), pp. 383-393. [10.1002/cncy.22385]
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