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Role of p16(INK4a) cytology testing as an adjunct to enhance the diagnostic specificity and accuracy in human papillomavirus-positive women within an organized cervical cancer screening program.
Acta Cytol 2012; 56(5):506-14AC

Abstract

OBJECTIVE

We evaluated the performance of cytologic p16(INK4a) (p16) immunostaining within a cervical cancer screening program for the categories of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LS after triage with high-risk human papillomavirus (HR-HPV) testing and atypical squamous cells, cannot exclude high-grade intraepithelial squamous lesion (ASC-H) and high-grade squamous intraepithelial lesion (HSIL). We also verified whether the routine introduction of p16 staining might enhance the specificity and positive predictive value (PPV) for cervical intraepithelial neoplasia grade 2 or higher (CIN2+) lesions predicted by a cytological screening test.

STUDY DESIGN

Performance of the p16 cytology test was estimated in 578 cytological samples, of which 213 were HR-HPV+ ASC-US, 186 were HR-HPV+ LSIL, 74 were ASC-H, 56 were HSIL-CIN2 and 49 were HSIL-CIN3. All samples had histological follow-up.

RESULTS

In the ASC-US category, p16 sensitivity was 91% for CIN2+ and 100% for CIN3, while specificity was 64 and 58%, respectively, negative predictive value (NPV) was 96 and 100%, respectively, and PPV was 39%. In the LSIL category, sensitivity was 77 and 75%, respectively, for CIN2+ and CIN3, while specificity was 64 and 57%, NPV was 93 and 98% and PPV was 30%. Sensitivity for ASC-H and HSIL-CIN3 was 100% for CIN2+ and CIN3, while for HSIL-CIN2 it was 91 and 95%, respectively; NPV for ASC-H was 100%, and for HSIL-CIN2 it was 43 and 86%, respectively. Follow-up examinations of 8 cases diagnosed as p16+ ASC-H and HSIL-CIN3, but histologically negative or CIN1 on the first biopsy, showed 4 CIN2 and 4 CIN3 lesions.

CONCLUSIONS

Sensitivity, specificity, PPV and NPV confirm the importance of the utilization of p16 in the categories ASC-US and LSIL after triage with an HR-HPV test. In the ASC-H and HSIL-CIN3 lesions, p16 was shown to be an excellent marker for picking up CIN2+ lesions, especially in cases with cytohistological discordance.

Authors+Show Affiliations

Azienda Sanitaria Regionale dell'Umbria USL2, U.O.C. Diagnostica di Laboratorio, U.O. Citologia, Perugia, Italia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23075891

Citation

Gustinucci, Daniela, et al. "Role of p16(INK4a) Cytology Testing as an Adjunct to Enhance the Diagnostic Specificity and Accuracy in Human Papillomavirus-positive Women Within an Organized Cervical Cancer Screening Program." Acta Cytologica, vol. 56, no. 5, 2012, pp. 506-14.
Gustinucci D, Passamonti B, Cesarini E, et al. Role of p16(INK4a) cytology testing as an adjunct to enhance the diagnostic specificity and accuracy in human papillomavirus-positive women within an organized cervical cancer screening program. Acta Cytol. 2012;56(5):506-14.
Gustinucci, D., Passamonti, B., Cesarini, E., Butera, D., Palmieri, E. A., Bulletti, S., ... Fulciniti, F. (2012). Role of p16(INK4a) cytology testing as an adjunct to enhance the diagnostic specificity and accuracy in human papillomavirus-positive women within an organized cervical cancer screening program. Acta Cytologica, 56(5), pp. 506-14. doi:10.1159/000338979.
Gustinucci D, et al. Role of p16(INK4a) Cytology Testing as an Adjunct to Enhance the Diagnostic Specificity and Accuracy in Human Papillomavirus-positive Women Within an Organized Cervical Cancer Screening Program. Acta Cytol. 2012;56(5):506-14. PubMed PMID: 23075891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Role of p16(INK4a) cytology testing as an adjunct to enhance the diagnostic specificity and accuracy in human papillomavirus-positive women within an organized cervical cancer screening program. AU - Gustinucci,Daniela, AU - Passamonti,Basilio, AU - Cesarini,Elena, AU - Butera,Daniela, AU - Palmieri,Emiliano Antonio, AU - Bulletti,Simonetta, AU - Carlani,Angela, AU - Staiano,Maria, AU - D'Amico,Maria Rosaria, AU - D'Angelo,Valentina, AU - Di Dato,Eugenio, AU - Martinelli,Nadia, AU - Malaspina,Morena, AU - Spita,Nicoletta, AU - Tintori,Beatrice, AU - Fulciniti,Franco, Y1 - 2012/09/27/ PY - 2011/12/09/received PY - 2012/04/16/accepted PY - 2012/10/19/entrez PY - 2012/10/19/pubmed PY - 2013/1/31/medline SP - 506 EP - 14 JF - Acta cytologica JO - Acta Cytol. VL - 56 IS - 5 N2 - OBJECTIVE: We evaluated the performance of cytologic p16(INK4a) (p16) immunostaining within a cervical cancer screening program for the categories of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LS after triage with high-risk human papillomavirus (HR-HPV) testing and atypical squamous cells, cannot exclude high-grade intraepithelial squamous lesion (ASC-H) and high-grade squamous intraepithelial lesion (HSIL). We also verified whether the routine introduction of p16 staining might enhance the specificity and positive predictive value (PPV) for cervical intraepithelial neoplasia grade 2 or higher (CIN2+) lesions predicted by a cytological screening test. STUDY DESIGN: Performance of the p16 cytology test was estimated in 578 cytological samples, of which 213 were HR-HPV+ ASC-US, 186 were HR-HPV+ LSIL, 74 were ASC-H, 56 were HSIL-CIN2 and 49 were HSIL-CIN3. All samples had histological follow-up. RESULTS: In the ASC-US category, p16 sensitivity was 91% for CIN2+ and 100% for CIN3, while specificity was 64 and 58%, respectively, negative predictive value (NPV) was 96 and 100%, respectively, and PPV was 39%. In the LSIL category, sensitivity was 77 and 75%, respectively, for CIN2+ and CIN3, while specificity was 64 and 57%, NPV was 93 and 98% and PPV was 30%. Sensitivity for ASC-H and HSIL-CIN3 was 100% for CIN2+ and CIN3, while for HSIL-CIN2 it was 91 and 95%, respectively; NPV for ASC-H was 100%, and for HSIL-CIN2 it was 43 and 86%, respectively. Follow-up examinations of 8 cases diagnosed as p16+ ASC-H and HSIL-CIN3, but histologically negative or CIN1 on the first biopsy, showed 4 CIN2 and 4 CIN3 lesions. CONCLUSIONS: Sensitivity, specificity, PPV and NPV confirm the importance of the utilization of p16 in the categories ASC-US and LSIL after triage with an HR-HPV test. In the ASC-H and HSIL-CIN3 lesions, p16 was shown to be an excellent marker for picking up CIN2+ lesions, especially in cases with cytohistological discordance. SN - 0001-5547 UR - https://www.unboundmedicine.com/medline/citation/23075891/Role_of_p16_INK4a__cytology_testing_as_an_adjunct_to_enhance_the_diagnostic_specificity_and_accuracy_in_human_papillomavirus_positive_women_within_an_organized_cervical_cancer_screening_program_ L2 - https://www.karger.com?DOI=10.1159/000338979 DB - PRIME DP - Unbound Medicine ER -