2022 · Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · paywalled
Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study
Van Keer et al.
The finding, in our words
Home-collected first-void urine testing for high-risk HPV showed sensitivity equivalent to clinician-collected cervical samples for detecting CIN2+ and CIN3, but with marginally lower specificity. This supports urine self-sampling as a viable decentralised screening method to improve coverage among unscreened women.
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 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.
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.
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.
This study found that the HarmoniaHPV assay on first-void urine collected via Colli-Pee and vaginal self-samples showed a relative sensitivity of 0.95 for detecting CIN2+ compared to cervical samples. The VenusHPV assay showed similar accuracy but required cut-off optimisation, supporting decentralised HPV screening.
Using the Novosanis Colli-Pee Small Volumes device, this study found that self-collected first-void urine had slightly lower sensitivity for detecting high-grade cervical intraepithelial neoplasia than cervical samples, CIN2+ ratio 0.91, 95% CI 0.83-0.99, with comparable specificity. This patient-centric, decentralised approach offers a feasible screening alternative despite a marginal reduction in sensitivity.