Assessment of the Fournier(®) cervical specimen self-sampling device using the Papanicolaou method.
BACKGROUND
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.


OBJECTIVE
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.


CONCLUSIONS
Sensitivity and specificity of the Fournier device test was comparable to Papanicolaou smears tests obtained using the traditional method with speculum examination.
Programa de Pós-graduação em Ciências Médicas, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil. rochagin@hotmail.com.br
Alexandre
A
da Silva Rocha
Pedro Guilherme
PG
Schaeffer
Luise
L
Meurer
Carolina Rigatti
CR
Hartmann
Maria Isabel Albano
MI
Edelweiss
D000328:Adult; D016022:Case-Control Studies; D002584:Cervix Uteri / Q000473:pathology*; D003127:Colposcopy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D011247:Pregnancy; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears / Q000295:instrumentation / Q000379:methods*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*