Enzyme-linked immunosorbent assay for p16(INK4a) - a new triage test for the detection of cervical intraepithelial neoplasia?
OBJECTIVE
To evaluate enzyme-linked immunosorbent assay (ELISA) for cyclin-dependent kinase inhibitor 2A protein (p16(INK4a) ) on self-collected cervicovaginal lavage samples as an additional triage test to identify women with high-grade cervical intraepithelial neoplasia (CIN).


METHODS
Retrospective feasibility, sensitivity and specificity study.


METHODS
University Medical School, Germany.


METHODS
One hundred and fifty-two patients from the colposcopy clinic were included.


METHODS
All women used a cervico-vaginal lavage device (Delphi Screener) for self-sampling and had gynecological examinations with Pap smears, cervical smears in ThinPrep PreservCyt solution and Cervatec medium for human papillomavirus (HPV) testing (Qiagen Hybrid Capture 2) and colposcopic examinations with biopsies if abnormalities were detected (72 women; 51%). All cytological samples were examined by p16(INK4a) ELISA.


METHODS
Sensitivity and specificity of p16(INK4a) ELISA for high-grade CIN.


RESULTS
Complete data were available for 140 women. Among these, 62 women (46%) presented with an atypical Pap smear and 65 (46.4%) were high-risk HPV positive in the reference smear sample. Seventeen women (12%) had CIN 3+. Twenty-seven (19%) physician-collected samples were p16(INK4a) ELISA positive. In contrast, p16(INK4a) ELISA turned out to be positive in only one (1%) vaginal lavage sample.


CONCLUSIONS
Our study shows that self-sampling with cervicovaginal lavage followed by p16(INK4a) ELISA is not suitable for the detection of high-grade CIN.
Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany. jentschke.matthias@mh-hannover.de
Matthias
M
Jentschke
Victoria
V
Lange
Philipp
P
Soergel
Peter
P
Hillemanns
D000293:Adolescent; D000328:Adult; D000368:Aged; D019941:Cyclin-Dependent Kinase Inhibitor p16; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008875:Middle Aged; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
D019941:Cyclin-Dependent Kinase Inhibitor p16