Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study

• Published in: British journal of cancer Vol. 105; no. 3; pp. 337 - 339
• Main Authors: Wikström, I, Lindell, M, Sanner, K, Wilander, E
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 26-07-2011; Nature Publishing Group
• Subjects: 631/1647/1407; 631/67/2322; 692/699/67/1517/1371; 692/699/67/1858; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Biopsy; Cancer; Cancer Research; Cellular biology; Cervical cancer; Cervical Intraepithelial Neoplasia - diagnosis; Cervix; Clinical Study; cytological screening; Drug Resistance; Early Detection of Cancer; Epidemiology; Female; Females; Gynecological surgery; human papilloma virus; Human papillomavirus; Humans; Lesions; Mass Screening; Medical research; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Midwifery; Molecular Medicine; Oncology; Papanicolaou Test; Papillomaviridae - isolation & purification; Papillomavirus Infections - diagnosis; Participation; Risk groups; self-sampling; Specimen Handling - methods; Tumors; Vagina; Vaginal Smears - methods; Womens health; Sweden; self-sampling; cervix; cytological screening; human papilloma virus; Human; Cytology; Samplings; Papovaviridae; Medical screening; Papillomavirus; Virus; Human papillomavirus; Randomization; Cancerology; Adult; Female; Papanicolaou smear test; Woman
• ISSN: 0007-0920; 1532-1827; 1532-1827
• DOI: 10.1038/bjc.2011.236

Background:
Most women with cervical cancer have not participated in Pap-smear screening. Self-sampling of vaginal fluid in combination with high-risk HPV testing may be a method to increase the attendance rate.
Methods:
A total of 4060 women, 39–60 years old, who had not attended the organised Pap-smear screening for 6 years or more were randomised into two equal groups. A study group was offered to self-sample vaginal fluid (Qvintip) at home and/or recommended to attend the Pap-smear screening. The collected fluid after self-sampling was examined for the presence of high-risk HPV (Hybrid Capture 2 method). Controls were only recommended to attend the Pap-smear screening. The end point was a histological identification of CIN2–3.
Results:
The participation rate was 39% (771 out of 2000) in the self-sampling group and 9% (188 out of 2060) in the conventional cytology (
P
<0.001). The number of histological CIN2–3 alterations detected was 0.4% (8 out of 2000) among women offered self-sampling of vaginal fluid and 0.07% (3 out of 4060) in women offered Pap-smears. The odds ratio (OR) for offering self-sampling and HPV testing instead of Pap-smear screening for detection of CIN2–3 was OR=5.42 (95% CI: 1.30–31.8).
Conclusion:
Offering self-sampling of vaginal fluid followed by a high-risk HPV test was considerably more effective for detection of histological CIN2–3 lesions in comparison with offering Pap-test in a midwife reception in women not regularly attending organised screening.