Agreement between INDICAID™ HPV (human papillomavirus) Urine Test and BD Onclarity™ HPV Assay in detection of high-risk HPV in self-collected urine samples

Self-collected urine samples matched clinician-collected cervical samples in detecting all seven CIN3 lesions among hrHPV-positive women when extended HPV typing was used, showing 82% concordance for hrHPV detection. This indicates urine self-collection could serve as a patient-centric, decentralised screening option for cervical precancer without compromising diagnostic yield.

Performance of urine samples compared to cervical samples for detection of precancer lesions among HPV-positive women attending colposcopy clinic in Mexico City — Meneses-León et al., Cancer causes & control : CCC · source ↗

• sti
• self-collection
• hpv
• liquid
• urine
• validation

Urine self-sampling for HPV detection showed good agreement with clinician-collected cervical samples (Kappa 0.72) under optimised conditions of 40 mM EDTA preservative, storage at 25°C, and processing within 72 hours. With a cost of USD 1.10 and high acceptability among women and healthcare workers, this method offers a practical decentralised screening approach for resource-limited settings.

Performance of an affordable urine self-sampling method for human papillomavirus detection in Mexican women — Hernández-López et al., PloS one · source ↗

• acceptability
• economics
• sti
• 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 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 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