Clinical Significance of Positive P16/Ki-67 Dual-Stained Cytology in Negative Papanicolaou Cytology
Sung-Ran Hong, Hy-Sook Kim, Tae Jin Kim, Jong-Sup Park. Cheil General Hospital, Kwandong University, Seoul, Korea; Cheil General Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea; School of Medicine, Catholic University of Korea, Seoul, Korea
Background: Dual immunocytochemistry for p16/Ki-67 has been reported as a useful biomarker to identify cells of underlying high-grade cervical intraepithelial neoplasia in the Papanicolaou (Pap) cytology. Positive p16/Ki-67 dual-stained cytology was rarely found in the category of negative cytology. The objective of this study was to investigate the clinical significance of positive p16/Ki-67 dual-stained cytology in women with Pap negative.
Design: Cytology p16/Ki-67 dual-staining test was performed on 691 liquid-based residual samples from a cohort of women with ASC-US/ LSIL and co-testing human papillomavirus (HPV) positive. There were 21 Pap negative smears showing positive p16/Ki-67 dual-stained cytology during periodic follow-up survey from 18 women. All 21 Pap negative smears were reviewed: cytology interpretations of two smears were revised as ASC-US on one original smear and on the other repeated smear.
Results: Positivity of p16/Ki-67 dual stained cytology was well correlated to cytology interpretation: 5.3% in Pap negative, 17.5% in ASC-US, 75.7% in ASC-H, 60.0% in LSIL and 100.0% in HSIL. Sensitivity (100.0%) for the detection of HSIL or specificity (95.2%) for Pap negative was higher than those of HPV test. Twelve of 18 women with positives dual-stained cytology in Pap negatives showed persistent infections by same HPV types (16, 16/52, 30, 31, 35/39, 51, 52, 56, 58, 68, 90). The duration of the persistent infection of same HPV type was 6 to 22 months (mean, 15month). Three of 12 women having persistent HPV infections were also disclosed negative cytology with negative dual-stained cytology. In these cytology, the duration of the persistent infection was short (mean, 7months). The others 6 women revealed 2 false positives for dual-stained cytology, and 4 variable infections in HPV type or positivity.
Conclusions: p16/Ki-67 dual stained cytology could provide high both sensitivity and specificity for the detection HSIL in Pap cytology. Positive p16/Ki-67 dual-stained cytology in Pap negative was highly associated with the persistent infections by same HPV type. Therefore, in cases of positive dual-stained cells morphologically showing benign atypical features, further follow-up would be necessary.
Category: Gynecologic & Obstetrics
Wednesday, March 6, 2013 1:00 PM
Poster Session VI # 207, Wednesday Afternoon