Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study

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

Vaginal self-sampling achieved higher pooled sensitivity and specificity than urine self-sampling for detecting high-risk HPV, making it the preferred option, while urine self-sampling remains a useful non-invasive choice for under-screened populations.

Diagnostic Accuracy of Urine and Vaginal Self-Sampling for Detection of High-Risk Human Papillomavirus: A Systematic Review and Meta-Analysis — Rakhat & Aimagambetova, Viruses · source ↗

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

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 Phase HPV Urine Test detected 14 high-risk HPV types from first-void urine samples, showing 93 per cent concordance with the Roche cobas 4800 reference assay after sequencing adjudication. The test demonstrated high precision, a low limit of detection, and ten-day stability at ambient temperature, supporting non-invasive, self-collected screening to improve access and participation.

Performance of a novel, urine-based test for the detection of cervical human papillomavirus infection — Manjeshwar et al., Journal of clinical microbiology · source ↗

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