Cervical cytological screening: Assessment of the Fournier® self-sampling device in a cervical pathology outpatient clinic

Background The objective of this study was to investigate the performance of the Fournier® self‐sampled device in the cytological diagnosis of cervical precursor or neoplastic lesions. The colposcopy and cervical biopsy were used as the gold standard evaluation. Method This was a case–control study performed at a cervical pathology outpatient clinic from January 2008 to October 2009. Samples were obtained through physician‐collected mode before a colposcopic evaluation. Liquid‐based cytology slides obtained with the device in question were stained using the Papanicolaou method and anti‐p16 immunocytochemistry and were analyzed by two pathologists blind to the histological and colposcopic diagnoses. Results Diagnostic performance for Fournier device using Papanicolaou technique was sensitivity 41.1% (Pathologist 1—P1) and 52.9% (Pathologist 2—P2) for diagnosing low‐grade intraepithelial lesions; for high‐grade lesions and cervical cancer, sensitivity was 68.7% (P1) and 75.0% (P2) and specificity was 81.8% (P1) and 73.8% (P2). When using the anti‐p16 immunocytochemistry, the sensitivity for diagnosing low‐grade intraepithelial lesions was 57.1% (P1) and 62.9% (P2), and the sensitivity was 87.5% (P1) and 93.8% (P2) for high‐grade lesions and cancer. The specificity was 75.0% (P1) and 54.4% (P2). Conclusions These results show that when used with “blind” physician‐collected cytology in an outpatient setting, the Fournier® device achieved a sensitivity and specificity comparable to those obtained by the Pap test traditionally collected during a speculum examination. Diagn. Cytopathol. 2015;43:802–809. © 2015 Wiley Periodicals, Inc.