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Mod Pathol. 2016 Aug;29(8):870-8. doi: 10.1038/modpathol.2016.80. Epub 2016 May 6.

p16/Ki-67 dual-stained cytology for detecting cervical (pre)cancer in a HPV-positive gynecologic outpatient population.

Author information

1
Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
2
Department of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, The Netherlands.
3
Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
4
Department of Pathology, Erasmus Medical Center, Rotterdam, The Netherlands.
5
Department of Obstetrics and Gynecology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
6
UMC Utrecht Cancer Center, Utrecht, The Netherlands.
7
Roosevelt Clinic, Leiden, The Netherlands.
8
Department of Obstetrics and Gynecology, Flevo Hospital, Almere, The Netherlands.
9
Department of Obstetrics and Gynecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.
10
DDL Diagnostic Laboratory, Rijswijk, The Netherlands.
11
Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.

Abstract

Women who test positive for a high-risk type of the human papillomavirus (HPV) require triage testing to identify those women with cervical intraepithelial neoplasia grade 3 or cancer (≥CIN3). Although Pap cytology is considered an attractive triage test, its applicability is hampered by its subjective nature. This study prospectively compared the clinical performance of p16/Ki-67 dual-stained cytology to that of Pap cytology, with or without HPV16/18 genotyping, in high-risk HPV-positive women visiting gynecologic outpatient clinics (n=446 and age 18-66 years). From all women, cervical scrapes (for Pap cytology, HPV16/18 genotyping, and p16/Ki-67 dual-stained cytology) and colposcopy-directed biopsies were obtained. The sensitivity of p16/Ki-67 dual-stained cytology for ≥CIN3 (93.8%) did neither differ significantly from that of Pap cytology (87.7%; ratio 1.07 and 95% confidence interval (CI): 0.97-1.18) nor from that of Pap cytology combined with HPV16/18 genotyping (95.1%; ratio 0.99 and 95% CI: 0.91-1.07). However, the specificity of p16/Ki-67 dual-stained cytology for ≥CIN3 (51.2%) was significantly higher than that of Pap cytology (44.9%; ratio 1.14 and 95% CI: 1.01-1.29) and Pap cytology combined with HPV16/18 genotyping (25.8%; ratio 1.99 and 95% CI: 1.68-2.35). After exclusion of women who had been referred because of abnormal Pap cytology, the specificity of p16/Ki-67 dual-stained cytology for ≥CIN3 (56.7%) remained the same, whereas that of Pap cytology (60.3%) increased substantially, resulting in a similar specificity of both assays (ratio 0.94 and 95% CI: 0.83-1.07) in this sub-cohort. In summary, p16/Ki-67 dual-stained cytology has a good clinical performance and is an interesting objective microscopy-based triage tool for high-risk HPV-positive women.

PMID:
27150161
DOI:
10.1038/modpathol.2016.80
[Indexed for MEDLINE]
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