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.