Assessment of the Fournier® Cervical Specimen Self-Sampling Device Using the Papanicolaou Method

Abstract

Introduction: Communities of socially excluded immigrant women, especially Muslim, Asian, Aboriginal and Maroon, are among the groups of women with low rates of cervical screening. Exclusion of the pelvic examination could result in a higher acceptance of the cervical screening among these communities and an increase in screening coverage. Aim: To assess the performance of the Fournier® cervical specimen self-sampling device for the cytological diagnosis of precursor or neoplastic lesions in the uterine cervix using the Papanicolaou method. Methods: A case-control study was conducted at the Cervical Pathology Outpatient Clinic. Liquid-based cytology slides were obtained by the Fournier device and stained using the Papanicolaou method. The slides were analyzed by two pathologists, blinded for the colposcopic and histological results and compared to Papanicolaou smears that were obtained using the traditional method of speculum examination. Results: There were 68 patients who were considered free from precursor or neoplastic cervical lesions. There were 35 cases of low-grade lesions, 13 cases of high-grade lesions and 3 cases of squamous-cell carcinoma. According to the first and second pathologists, the sensitivities of the device for identifying precursor or neoplastic cervical lesions were 50.0 and 60.0%, and the specificities of the method were 81.8 and 73.8%. According to the first and second pathologists, the positive predictive values of the diagnostic test were 0.67 and 0.63, and the negative predictive values were 0.68 and 0.71, respectively. Conclusion: Sensitivity and specificity of the Fournier device test was comparable to Papanicolaou smears tests obtained using the traditional method with speculum examination.

Validity and acceptance of self vs conventional sampling for the analysis of human papillomavirus and Pap smear

“…The curtailed validity of cytology versus HPV, however, should not lead us to ignore the possibilities of reflex cytology in self-sampling. The sensitivity and the specificity of our self-collected smears show very similar figures to those of other works with the same gold standard 15,27 , allowing us to avoid visits only for Pap smear collection, whenever the self-sample resulted in a smear with non-reactive atypia or dysplasia 24,25 . During our inquiries about the validity of the scrutinized tests, we observed a much higher ratio of unsatisfactory smears among specimens taken by the gynaecologists than by the women.…”

Cervical Cancer Screening Postpandemic: Self-Sampling Opportunities to Accelerate the Elimination of Cervical Cancer

“…153 Few studies have compared the accuracy of cytology between self-samples and clinician-collected samples using different types of self-sample devices, demonstrating fair-moderate agreement and lower sensitivity on self-collected samples. [153][154][155][156][157][158] In one of the earliest studies of self-collected Pap tests, 154 sensitivity for self-collected cytology using a traditional cytobrush was significantly lower than clinician-sampled cytology (55% vs 85%); however, specificity for self-collected samples was higher (85% vs 73%). Since that time, a variety of self-collection methods and commercial and noncommercial devices have been investigated, with varying results.…”

Self-Collection Tools for Routine Cervical Cancer Screening: A Review

“…Previous studies have examined the sensitivity and predictive value of HPV detection by comparing self-collected and clinician collected samples for HPV testing (Cerigo et al, 2012;da Silva Rocha et al, 2012). Studies have shown that self-sampling yields more often HPV-positive results compared to physician-collected samples (Cerigo et al, 2012).…”