A absolute of 4060 women, 39–60 years old, who had not alternate in the organised Pap-smear screening for 6 years or added were calm from the bounded abstracts abject at the Administration of Pathology and Cytology, Uppsala University Hospital, Sweden in January 2007.
The women were about disconnected into a abstraction accumulation of 2000 women and a ascendancy accumulation of 2060 women. In the abstraction group, all women were offered self-sampling at home with a self-sampling accessory (Qvintip, Aprovix AB, Uppsala, Sweden) as an accessory to organised Pap-smear screening. In the ascendancy group, women were alone brash to participate in Pap-smear screening. In the organised Pap-smear screening, women 25–60 years old are arrive for apply sampling every third year. Women, who accept not to appear receives added allurement belletrist already a year.
All 2000 women in the abstraction accumulation were beatific an advice letter by post, and afterwards a few days, they accustomed the self-sampling device, instructions how to accomplish the sampling of vaginal aqueous and to accelerate the calm actual to our class in the enclosed, prepaid acknowledgment letter. The action was chargeless of allegation and the women were additionally reminded in a additional invitation. At the laboratory, the samples were acclimated for high-risk HPV testing with the Hybrid Capture 2 (hc2) adjustment (Qiagen AB, Solna, Sweden). The HPV assay identifies 13 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68). The hc2 adjustment can ascertain HPV DNA concentrations over 1 pg ml−1, which is proportional to the ablaze discharge of the absolute ascendancy and corresponds to 5000 HPV genomes per case in the well. The after-effects of the HPV assay were mailed to all women accommodating in the study. All advice on women in the abstraction accumulation was calm in the database of the department, calm with annal on the Pap-smear screening and histopathological examinations.
The women who were high-risk HPV absolute were recommended a aftereffect assay at a midwife accession or a gynaecological surgery. In women advised by a gynaecologist, a biopsy from the cervix was obtained, admitting in women accessory a midwife accession a again cytology, generally in aggregate with a cervical sample for HPV analysis, was taken. All women offered self-sampling at home were additionally offered to participate in the organised Pap-smear screening.
The women in the ascendancy accumulation were arrive to a midwife accession for accumulating of cervical smear, aural the framework of the organised screening programme. Women with ASCUS or CIN1 alterations empiric in the screening were alleged for alteration at the midwife accession and women with CIN2–3 corpuscle changes were accepted to a gynaecological accession for colposcopy and cervical biopsy. The women paid 100 SEK (around 10 EUR) alone for the aboriginal Pap-smear collection.
At the end of December 2007, all women who had performed self-sampling of vaginal apply at home in aggregate with a high-risk HPV test, and all women in the abstraction and ascendancy groups accommodating in the Pap-smear screening were identified. Women who were HPV absolute or showed aberrant assay (ASCUS–CIN3) were followed until December 2009. The end point of the abstraction was a histopathological CIN2–3 lesions empiric in cervical biopsies or afterwards cervical cone resection.
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