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
Martinelli et al.
The finding, in our words
Self-collected vaginal and first-void urine samples achieved substantial agreement with clinician-collected cervical samples for HPV detection using the BD Onclarity™ assay, with vaginal samples showing 95.3% overall positive agreement (kappa 0.890) and urine samples 90.6% agreement (kappa 0.776) when no clinical cut-off was applied. This supports decentralised, patient-centric cervical screening programmes.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
Hsiao et al., The journal of obstetrics and gynaecology research (paywalled) · source ↗
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.
Chen et al., Journal of lower genital tract disease (paywalled) · source ↗
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.
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.
Chu et al., BJOG : an international journal of obstetrics and gynaecology · source ↗
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.
Manjeshwar et al., Journal of clinical microbiology · source ↗