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Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing.

Eperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P - BMC Cancer (2013)

Bottom Line: Women reported the two Self-HPV tests as highly acceptable.Self-HPV using dry swab transfer does not appear to compromise specimen integrity.Further study in a large screening population is needed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gynecology and Obstetrics, Geneva University Hospitals and Faculty of Medicine, Boulevard de la Cluse 30, 1211, GENEVA 14, Switzerland.

ABSTRACT

Background: To evaluate if human papillomavirus (HPV) self-sampling (Self-HPV) using a dry vaginal swab is a valid alternative for HPV testing.

Methods: Women attending colposcopy clinic were recruited to collect two consecutive Self-HPV samples: a Self-HPV using a dry swab (S-DRY) and a Self-HPV using a standard wet transport medium (S-WET). These samples were analyzed for HPV using real time PCR (Roche Cobas). Participants were randomized to determine the order of the tests. Questionnaires assessing preferences and acceptability for both tests were conducted. Subsequently, women were invited for colposcopic examination; a physician collected a cervical sample (physician-sampling) with a broom-type device and placed it into a liquid-based cytology medium. Specimens were then processed for the production of cytology slides and a Hybrid Capture HPV DNA test (Qiagen) was performed from the residual liquid. Biopsies were performed if indicated. Unweighted kappa statistics (к) and McNemar tests were used to measure the agreement among the sampling methods.

Results: A total of 120 women were randomized. Overall HPV prevalence was 68.7% (95% Confidence Interval (CI) 59.3-77.2) by S-WET, 54.4% (95% CI 44.8-63.9) by S-DRY and 53.8% (95% CI 43.8-63.7) by HC. Among paired samples (S-WET and S-DRY), the overall agreement was good (85.7%; 95% CI 77.8-91.6) and the κ was substantial (0.70; 95% CI 0.57-0.70). The proportion of positive type-specific HPV agreement was also good (77.3%; 95% CI 68.2-84.9). No differences in sensitivity for cervical intraepithelial neoplasia grade one (CIN1) or worse between the two Self-HPV tests were observed. Women reported the two Self-HPV tests as highly acceptable.

Conclusion: Self-HPV using dry swab transfer does not appear to compromise specimen integrity. Further study in a large screening population is needed.

Trial registration: ClinicalTrials.gov: NCT01316120.

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Related in: MedlinePlus

Agreement of type-specific HPV detection between S-WET, S-DRY and HC. Note: S-DRY = dry vaginal swabs used for self-sampling; S-WET = vaginal swabs with wet transport medium used for self- sampling; HC = Hybrid Capture physician sampeld; *HPV 16 in single or mixed infections; **HPV 18 in single or mixed infections; ***One or more of the non-16/18 high risk HPV types, in single or mixed infections.
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Figure 1: Agreement of type-specific HPV detection between S-WET, S-DRY and HC. Note: S-DRY = dry vaginal swabs used for self-sampling; S-WET = vaginal swabs with wet transport medium used for self- sampling; HC = Hybrid Capture physician sampeld; *HPV 16 in single or mixed infections; **HPV 18 in single or mixed infections; ***One or more of the non-16/18 high risk HPV types, in single or mixed infections.

Mentions: The overall test agreement between S-WET and S-DRY was 85.7% (95% CI 77.8–91.6), with a 79.2% positive agreement. Cohen’s kappa for inter-test agreement was 0.70 (95% CI 0.53-0.88). Positive agreement for type specific HPV was 77.3% (95% CI 68.2–84.9). The inter-test agreement was good between S-WET and S-DRY for type-specific detection of HPV 16 and non-16/18 HPV types as well as for all HPV positive cases. The inter-test agreements between HC and S-DRY and between HC and S-WET were inferior to the inter-test agreement of S-WET and S-DRY (Figure 1, Table 1).


Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing.

Eperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P - BMC Cancer (2013)

Agreement of type-specific HPV detection between S-WET, S-DRY and HC. Note: S-DRY = dry vaginal swabs used for self-sampling; S-WET = vaginal swabs with wet transport medium used for self- sampling; HC = Hybrid Capture physician sampeld; *HPV 16 in single or mixed infections; **HPV 18 in single or mixed infections; ***One or more of the non-16/18 high risk HPV types, in single or mixed infections.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750271&req=5

Figure 1: Agreement of type-specific HPV detection between S-WET, S-DRY and HC. Note: S-DRY = dry vaginal swabs used for self-sampling; S-WET = vaginal swabs with wet transport medium used for self- sampling; HC = Hybrid Capture physician sampeld; *HPV 16 in single or mixed infections; **HPV 18 in single or mixed infections; ***One or more of the non-16/18 high risk HPV types, in single or mixed infections.
Mentions: The overall test agreement between S-WET and S-DRY was 85.7% (95% CI 77.8–91.6), with a 79.2% positive agreement. Cohen’s kappa for inter-test agreement was 0.70 (95% CI 0.53-0.88). Positive agreement for type specific HPV was 77.3% (95% CI 68.2–84.9). The inter-test agreement was good between S-WET and S-DRY for type-specific detection of HPV 16 and non-16/18 HPV types as well as for all HPV positive cases. The inter-test agreements between HC and S-DRY and between HC and S-WET were inferior to the inter-test agreement of S-WET and S-DRY (Figure 1, Table 1).

Bottom Line: Women reported the two Self-HPV tests as highly acceptable.Self-HPV using dry swab transfer does not appear to compromise specimen integrity.Further study in a large screening population is needed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Gynecology and Obstetrics, Geneva University Hospitals and Faculty of Medicine, Boulevard de la Cluse 30, 1211, GENEVA 14, Switzerland.

ABSTRACT

Background: To evaluate if human papillomavirus (HPV) self-sampling (Self-HPV) using a dry vaginal swab is a valid alternative for HPV testing.

Methods: Women attending colposcopy clinic were recruited to collect two consecutive Self-HPV samples: a Self-HPV using a dry swab (S-DRY) and a Self-HPV using a standard wet transport medium (S-WET). These samples were analyzed for HPV using real time PCR (Roche Cobas). Participants were randomized to determine the order of the tests. Questionnaires assessing preferences and acceptability for both tests were conducted. Subsequently, women were invited for colposcopic examination; a physician collected a cervical sample (physician-sampling) with a broom-type device and placed it into a liquid-based cytology medium. Specimens were then processed for the production of cytology slides and a Hybrid Capture HPV DNA test (Qiagen) was performed from the residual liquid. Biopsies were performed if indicated. Unweighted kappa statistics (к) and McNemar tests were used to measure the agreement among the sampling methods.

Results: A total of 120 women were randomized. Overall HPV prevalence was 68.7% (95% Confidence Interval (CI) 59.3-77.2) by S-WET, 54.4% (95% CI 44.8-63.9) by S-DRY and 53.8% (95% CI 43.8-63.7) by HC. Among paired samples (S-WET and S-DRY), the overall agreement was good (85.7%; 95% CI 77.8-91.6) and the κ was substantial (0.70; 95% CI 0.57-0.70). The proportion of positive type-specific HPV agreement was also good (77.3%; 95% CI 68.2-84.9). No differences in sensitivity for cervical intraepithelial neoplasia grade one (CIN1) or worse between the two Self-HPV tests were observed. Women reported the two Self-HPV tests as highly acceptable.

Conclusion: Self-HPV using dry swab transfer does not appear to compromise specimen integrity. Further study in a large screening population is needed.

Trial registration: ClinicalTrials.gov: NCT01316120.

Show MeSH
Related in: MedlinePlus