REQUEST A SAMPLE
Contact Us

Unlocking Access to Self-Collection for HPV Screening Through Material Innovation

CHALLENGE

Oasis Diagnostics®, a company specializing in self-collection devices, faced challenges with insufficient vaginal sampling in their Fem•Collect™ device.

  • Variations in the amount and quality of the collected samples, even with the same user, led to unreliable outcomes.
  • The presence of inhibitory molecules affected the accuracy of nucleic acid amplification, further compounding assay sensitivity issues.

Addressing these challenges required an innovative solution to standardize sampling procedures and mitigate inhibitory factors for more reliable diagnostics.

SOLUTION

Porex developed a vaginal self-collection swab that collects and filters cervicovaginal samples.

  • Material manufactured for consistent collection volume and efficient release.
  • Swab filter material is soft, supporting comfortable patient experience.

Swab retains inhibitors and contaminants, generating a highly pure sample for reliable molecular diagnostics.

For self-collection to succeed at scale, DNA quality must match clinician-collected reference samples. This requirement places DNA swab material selection at the center of device performance.

To evaluate the swab performance, Oasis Diagnostics® and Porex worked with Salitrack Pharma ApS (Denmark) to conduct a small pilot study on vaginal sample self-collection for HPV testing.

STUDY SET-UP

  • 21 women selected from three testing sites across France and India.
  • Inclusion criteria: Age 25-63 with history of high-risk HPV. Had not undergone cervical screening in past year and not pregnant.

SAMPLE COLLECTION

Three different vaginal sampling methods were evaluated for each participant:

  • Clinician-collected cervicovaginal samples collected by a licensed clinician using a colposcopy brush.
  • Fem•Collect™ device by Oasis Diagnostics® collected by patient at home. Patient pushed plunger to release sample into tube with buffer.
  • Competitor C vaginal self-collection device collected by patient at home. Sample stored per instructions.

Fem•Collect™ device
sample collection

STUIDY METHODS & ANALYSIS

All samples shipped to Salitrack Pharma ApS (Denmark).

  • For each sample, DNA was isolated and screened using the cobas® HPV assay (Roche) to screen for high-risk HPV.
  • The Shapiro-Wilk test was used to determine the normality of continuous variables
  • The McNemar test was applied to evaluate differences in HPV positivity between paired sampling methods.
  • Concordance between sampling methods was measured using Cohen’s Kappa coefficient.
  • A significance level of p < 0.05 was set for all comparisons

RESULTS

DNA Quality

  • DNA analysis showed that the Fem•Collect™ device enabled robust DNA yield and purity equivalent to the gold standard clinician samples and superior to the Competitor C self-collection device.

These results reflect the impact of
collection material on DNA yield and purity

HPV Screening

  • All three testing methods had similar HPV detection rates
  • Fem•Collect™ had high concordance with clinician reference standards compared to Competitor C

Patient Sample Collection Preference

  • Patients were asked a short set of Yes/No questions related to the usability of vaginal self-sampling devices.
  • Overall, patients preferred self-collection methods over clinician sample collection

HIGH-QUALITY DNA RECOVERY WITH A POREX HRM SWAB ENABLES RELIABLE HPV DETECTION IN SELF-COLLECTED SAMPLES

Porex Logo

To see Fem•Collect™ samples yourself, visit the sample page to request them now.

To learn more about the Fem•Collect™ device and study, as well as how Porex enables saliva sample collection, check out this webinar.