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Br J Cancer. 2014 Mar 18;110(6):1579-86. doi: 10.1038/bjc.2014.34. Epub 2014 Feb 11.

Triaging borderline/mild dyskaryotic Pap cytology with p16/Ki-67 dual-stained cytology testing: cross-sectional and longitudinal outcome study.

Author information

  • 1Department of Pathology, VU University Medical Center, PO BOX 7057, 1000 MB Amsterdam, The Netherlands.
  • 2Department of Epidemiology and Biostatistics, VU University Medical Center, PO BOX 7057, 1000 MB Amsterdam, The Netherlands.
  • 3Department of Pathology, Erasmus University Medical Center, PO BOX 2040, 3000 CA Rotterdam, The Netherlands.
  • 4Department of Obstetrics and Gynaecology, VU University Medical Center, PO BOX 7057, 1000 MB Amsterdam, The Netherlands.
  • 5Ventana Medical Systems, Inc., 1910 E Innovation Park Drive, Tucson, AZ 85755, USA.
  • 6Saltro Diagnostic Centre, PO BOX 9300, 3506 GH Utrecht, The Netherlands.

Abstract

BACKGROUND:

Women with borderline/mildly dyskaryotic (BMD) cytology smears are currently followed up with repeat testing at 6 and 18 months. The objective of this study is to analyse the cross-sectional and longitudinal performance of p16/Ki-67 dual-stained cytology for the detection of cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) and CIN2+ in women with BMD, and to compare the results with baseline human papillomavirus (HPV) testing.

METHODS:

Conventional Pap cytology specimens of 256 women with BMD were dual stained for p16/Ki-67 retrospectively, and compared with baseline HPV results and long-term follow-up results.

RESULTS:

p16/Ki-67 dual-stained cytology showed a sensitivity of 100%, a specificity of 64.4% and a negative predictive value (NPV) of 100.% for CIN3+. Human papillomavirus testing demonstrated similar sensitivity (96.3%), and NPV (99.1%), but a significantly lower specificity (57.6%; P=0.024) for CIN3+. Sensitivity, specificity and NPV for CIN2+ of dual-stained cytology were 89.7%, 73.1% and 95.1%, respectively, which was similar when compared with HPV testing. Dual-stained cytology showed a significant lower referral rate than HPV testing (43.6% vs 49.1%; P=0.043). During long-term follow-up, no CIN3+ lesions developed in HPV-positive, dual-stained negative women.

CONCLUSIONS:

Comparable sensitivity and NPV of dual-stained cytology for CIN3+, combined with a significantly higher specificity, makes p16/Ki-67 dual-stained cytology a viable alternative to HPV testing for triaging BMD.

PMID:
24518601
PMCID:
PMC3960614
DOI:
10.1038/bjc.2014.34
[PubMed - indexed for MEDLINE]
Free PMC Article
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