Are adjunctive markers useful in routine cervical cancer screening? Application of p16(INK4a) and HPV-PCR on ThinPrep samples with histological follow-up.
The objectives of the study were to evaluate 1) the diagnostic sensitivity and specificity of p16(INK4a) as a marker for high-grade cervical lesions, 2) the results of a real-time polymerase chain reaction detecting high-risk human papillomavirus, and 3) the interobserver variability of the p16(INK4a) interpretation.A total of 232 ThinPrep samples were stained for p16(INK4a), and HPV-DNA PCR was performed on 107 specimens with inclusion of both benign and abnormal cytology. Histological follow-up information was collected. The diagnostic sensitivity of ASC+ with CIN2+ in histology as endpoint was 96% for p16(INK4a) and 100% for HR-HPV DNA PCR, and the diagnostic specificity was 41% and 27%, respectively. If p16(INK4a) had been used for triage of the ASC samples, then 18 patients (42%) could have been spared unnecessary follow-up procedures compared to six patients (21%) with the HR-HPV DNA test.
Department of Pathology, Odense University Hospital, Odense, Denmark. doris.schledermann@ouh.regionsyddanmark.dk
D
D
Schledermann
B T
BT
Andersen
K
K
Bisgaard
M
M
Dohse
D
D
Ejersbo
B
B
Hoelund
P
P
Horal
M
M
Lindh
W
W
Ryd
D000328:Adult; D014408:Biomarkers, Tumor / Q000032:analysis*; D002584:Cervix Uteri / Q000737:chemistry / Q000821:virology; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000032:analysis*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006652:Histological Techniques; D006801:Humans; D007150:Immunohistochemistry; D008875:Middle Aged; D015588:Observer Variation; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
D014408:Biomarkers, Tumor; D019941:Cyclin-Dependent Kinase Inhibitor p16; D004279:DNA, Viral