Two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.

• Register: ISRCTN
• Last refreshed on: 26 June 2023
• Main ID: ISRCTN43310942
• Date of registration: 22/05/2015
• Prospective Registration: No
• Primary sponsor: Geneva University Hospitals
• Public title: Two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.
• Scientific title: Randomized comparison of two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.
• Date of first enrolment: 01/03/2014
• Target sample size: 130
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN43310942
• Study type: Interventional
• Study design: Women will be invited to perform two self-sampling (FTA and v-DRY) in our colposcopy clinic in Geneva. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic test (Real-time PCR). (Prevention)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Rosa Catarino

Key inclusion & exclusion criteria

Inclusion criteria: 1. At least 30 years old
2. Attending colposcopy clinic
3. Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)
Exclusion criteria: 1. Pregnancy
2. Previous Hysterectomy
3. Virgin
4. Not able to comply with protocol study

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical pre-cancer and cancer.
Cancer

Intervention(s)

Women were invited to perform two self-sampling (FTA and v-DRY). Randomization of the sequence of the two self-HPV tests was done to avoid potential bias that may advantage the “first” test.
The research nurse would then give oral instructions to the patients. For specimen collection, participants were instructed to wash their hands before the procedure. Each participant received a package containing specimen collection kit. The brush used for self-collection using the FTA cartridge was the Rovers Viva-brush (Rovers Medical Devices B.V., Oss, The Netherlands), whereas the swab used for the self-collection in the v-DRY method was the flocked mid-turbinate swab (Copan FLOQSwabs™; Copan, Italy). Recommendations were to hold the brush/swab by the end of the handle, to insert the brush/swab into the vagina, avoiding contact with the external genitalia, until they meet resistance (at least 6 cm). Once they met resistance, they should gently turn the brush/swab three to five times. Subsequently the brush should be applied to the FTA cartridge by pressing it onto the middle of sample area indicated and then rotate de brush 3-5 times across that area. On the other hand, the swab was just inserted inside its plastic sleeve (v-DRY).

During the colposcopy consultation, the physician collected also a sample using specimen transport medium (Copan ESwab, Brescia, Italy) for HPV testing.

HPV analysis was performed using the Anyplex II HPV28 (H28) Detection test (Seegene, Seoul, South Korea).

Primary Outcome(s)

Agreement between collection methods in terms of HPV positivity, measured using kappa statistic and corresponding standard deviation.

Secondary Outcome(s)

1. Sensitivity and specificity to detect high-risk HPV using the result from the physician’s collected samples as gold standard was reported, as well as, sensitivity and specificity of the three sampling methods for abnormal Pap smear. Because of the small number of high-grade squamous intraepithelial lesion (HSIL) or carcinomas in our population, we assessed sensitivity and specificity for low-grade squamous intraepithelial lesion or greater lesions (LSIL+). The two-tailed McNemar’s test was used for mutual comparison of sensitivity and specificity.
2. Positive and negative predictive values to detect high-risk HPV using the physician’s collected samples as gold standard
3. Positive and negative predictive values of the three sampling methods to detect high-risk HPV for abnormal Pap smear results
4. Agreement between collection methods in terms of HPV positivity, according to cytological results
Agreement between collection methods according to cytological results was measured using kappa statistic and corresponding standard deviation
5. Proportion of positive agreement (PPA) between paired FTA and Vaginal dry swabs (v-DRY) samples. The proportion of positive agreement (PPA) between paired FTA and v-DRY samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both dry samples, f1=the number of samples that were positive for FTA and g1=the number of samples that were positive for v-DRY
6. Proportion of positive agreement (PPA) between paired self collection methods (combined results of FTA and v-DRY) and physician’s collected sample. The proportion of positive agreement (PPA) between paired self collection methods and physician’s collected samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both samples, f1=the number of samples that were positive for the self-collection methods and g1=the number of samples that were positive for the physician’s collected sample
7. Women’s preference regarding the collection methods. Women completed a self-administered questionnaire

Data will be analyzed with a statistical analysis software package (StataCorp.2013., Stata Statistical Software: Release 13. College Station, TX, USA).

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Research Projects for Development (Projets Recherche & Développement) (PRD) - HUG

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Cantonal Human Research Ethics Commission of Geneva, 17/.02/2014, ref: CCER, CER: 14-011

Results

• Results available: Yes
• Date Completed: 01/03/2015