Clinical Performance of the OncoPredict HPV Screening Assay on Self-Collected Vaginal and Urine Specimens (VALHUDES)

High-risk HPV testing on first-void urine self-collected with Colli-Pee was about as sensitive, relative sensitivity 0.95, and specific for CIN2+ as clinician-taken cervical samples, supporting standardised first-void urine as a valid screening matrix.

Clinical and analytical evaluation of high-risk HPV testing on Colli-Pee first-void urine using the VALHUDES protocol — Van Keer et al., Gynecologic Oncology (paywalled) · source ↗

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

In women with HPV, first-void urine collected with the Colli-Pee device had higher HPV DNA concentrations than urine collected with a standard cup, although this advantage disappeared at high HPV DNA loads. Timing of collection (morning versus later) did not affect HPV DNA copies.

Human papillomavirus detection in urine: Effect of a first-void urine collection device and timing of collection — Pattyn et al., Journal of virological methods (paywalled) · source ↗

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

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