Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First-Void Urine Collector

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 Worse — Chen et al., Journal of lower genital tract disease (paywalled) · source ↗

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

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 Study — Chu et al., BJOG : an international journal of obstetrics and gynaecology · source ↗

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

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 protocol — van et al., Gynecologic oncology (paywalled) · source ↗

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

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.

Accuracy of Liferiver HarmoniaHPV and VenusHPV Assays on Urine and Vaginal Self-Samples — Latsuzbaia et al., Journal of medical virology · source ↗

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

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