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2025 · Journal of medical virology · open access

Accuracy of Liferiver HarmoniaHPV and VenusHPV Assays on Urine and Vaginal Self-Samples

Latsuzbaia et al.

The finding, in our words

This study found that the HarmoniaHPV assay on first-void urine collected via Colli-Pee and vaginal self-samples showed a relative sensitivity of 0.95 for detecting CIN2+ compared to cervical samples. The VenusHPV assay showed similar accuracy but required cut-off optimisation, supporting decentralised HPV screening.

A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.

Labels

  1. 2026

    This meta-analysis found that self-collected urine samples for HPV testing had lower sensitivity for detecting high-grade lesions compared to physician-collected cervical specimens. The use of a first-void collection device such as Colli-Pee was associated with marginally higher sensitivity than general urine sampling.

    Accuracy of HPV Testing Using Self-collected Urine Compared With Physician-collected Cervical Specimen for HSIL or WorseChen et al., Journal of lower genital tract disease (paywalled) · source ↗

    • urine
    • first-void
    • colli-pee
    • self-collection
    • validation
    • hpv
    • sti
  2. 2026

    For decentralised testing, a study found dry vaginal self-samples using Copan FLOQSwabs stored up to two weeks at room temperature maintain DNA quality. However, first-void urine collected with the Colli-Pee device may be less sensitive for HPV detection, showing lower positivity and higher cycle threshold values, median Ct 30 versus 27 for other samples.

    Evaluation of the Quality and Suitability of Self-Collected Vaginal and Urine Samples for Human Papillomavirus Testing: A Prospective Matched StudyChu et al., BJOG : an international journal of obstetrics and gynaecology · source ↗

    • colli-pee
    • first-void
    • sti
    • self-collection
    • dried
    • hpv
    • urine
    • validation
  3. 2025

    The EUROArray HPV test achieved similar sensitivity and specificity for CIN2+ detection using first-void urine and vaginal self-samples compared with clinician-collected cervical samples, supporting the use of self-collection for cervical screening.

    EUROArray HPV test accuracy for cervical precancer in self- vs. clinician-collected samples using the VALHUDES protocolvan et al., Gynecologic oncology (paywalled) · source ↗

    • urine
    • first-void
    • colli-pee
    • self-collection
    • validation
    • hpv
  4. 2025

    Using the Novosanis Colli-Pee Small Volumes device, this study found that self-collected first-void urine had slightly lower sensitivity for detecting high-grade cervical intraepithelial neoplasia than cervical samples, CIN2+ ratio 0.91, 95% CI 0.83-0.99, with comparable specificity. This patient-centric, decentralised approach offers a feasible screening alternative despite a marginal reduction in sensitivity.

    Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First-Void Urine CollectorVan Keer et al., Journal of medical virology (paywalled) · source ↗

    • urine
    • first-void
    • colli-pee
    • self-collection
    • validation
    • hpv
  5. 2024

    An independent VALHUDES evaluation found HPV screening on Colli-Pee first-void urine detected high-grade cervical lesions with sensitivity comparable to clinician-collected cervical samples, reinforcing urine self-sampling for cervical screening.

    Clinical Performance of the OncoPredict HPV Screening Assay on Self-Collected Vaginal and Urine Specimens (VALHUDES)Giubbi et al., J. Medical Virology · source ↗

    • colli-pee
    • first-void
    • self-collection
    • hpv
    • liquid
    • urine
    • validation