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Cytology was carried out at private cytology laboratories, and cytological diagnosis was carried out according to The French National Agency of Health consensus guidelines on the quality control of cervical smear screening [16] and formulated according to the 2001 Bethesda classification [17].Those carrying out cervical cytology analyses were blinded to the result of HPV genotyping. Flocked swabs (Copan Diagnostics, Brescia, Italy) were used as self-sampling devices. The women sampled their vaginal fluid using UTM tubes containing universal transport medium. The collected material was returned via mail in a prepaid envelope to the Department Fluconazole of Virology of the Timone Hospital (Marseille, France) and was stored at ?20��C until use. After thawing, 250?��L of vaginal cell suspension was used for DNA purification using the QIAampDNA Mini Kit (QIAGEN, Courtaboeuf, France) modified as follows: samples were incubated at 56��C for 2?h in lysis solution containing proteinase K. The DNA was eluted in 100?��L Paclitaxel of elution buffer and stored at ?20��C until use. HPV genotyping was assessed by PCR (MY09/ MY11 primers), sequencing, phylogenetic analysis, and cloning if necessary, as described [13]. Quantitations of HPV 16 and 18 positive samples were performed using the quantitative duplex real-time PCR method, as reported [8]. HPV viral load was expressed as the number of HPV copies per million cells. To follow-up abnormal tests, the virology and cytology laboratories communicated their results to the management centre ��ARCADES�� in charge of sending them to the women with recommendations and to their referent physicians. A reminder regarding the management of abnormal results was also sent to these practitioners (gynaecologycal BGJ398 examination and colposcopy in the case of abnormal Pap-test and gynaecological examination and Pap-test if HPV-HR positive). The collection of follow-up data for abnormal tests was also monitored (mailing and telephone call) by the ARCADES centre after 3, 6 and 12?months. Ethical approval was given by the ethical committee of ��Sud Mediterran��e 2 and Marseille 2�� for all randomized studies on HPV testing in the Bouches du Rh?ne area performed by the ARCADES association. Statistical analysis was performed using the spss (version 12.0) and epi info 6 softwares. A Yates's corrected chi-squared test was used to detect differences between groups. A descriptive analysis of the frequency and the distribution of the various HPV types and a comparison of median values using the Kruskal�CWallis test were performed. In the study group, the rate of attendance at the second Pap-smear screening invitation was 7.3%, compared with 25.1% who carried out self-sampling of vaginal fluid at home (p?
