Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples

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

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 HPV testing using self-collected vaginal and urine samples showed sensitivities of 88.6% and 81% for detecting cervical precancer. Using a standardised device for first-void urine increased sensitivity to 86.6%, supporting decentralised patient-centric screening, though data on specificity and specific commercial devices were not consistently reported.

Diagnostic Performance of HPV Testing Using Self-Collected Urine and Vaginal Samples for Detecting Cervical Precancer or Worse: A Meta-Analysis — Hsiao et al., The journal of obstetrics and gynaecology research (paywalled) · source ↗

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

This randomised sub-study found return rates of 10.4% for Colli-Pee, 10.1% for FLOQSwabs and 7.4% for Evalyn-Brush. All devices yielded sufficient DNA with low invalid rates, but the authors noted the study was limited by low overall participation.

Comparison of three different hpv self-sampling tools - a subanalysis of the prospective, randomized hannover self-collection study — Hempel et al., Archives of gynecology and obstetrics · source ↗

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