2025 · Journal of clinical microbiology · open access
Optimization and analytical validation of the Allplex HPV28 genotyping assay for use in first-void urine samples
Bell et al.
The finding, in our words
The study validated the Allplex HPV28 assay for use with first-void urine samples collected using a Colli-Pee device, finding good agreement with a reference method and that it works without pre-centrifugation. This provides a reliable, non-invasive option for HPV screening and vaccine monitoring, which is important for increasing participation in decentralised settings.
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.
Chen et al., Journal of lower genital tract disease (paywalled) · source ↗
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 ↗
A study of 100 Brazilian women with high-grade cervical lesions found excellent concordance for high-risk HPV detection between clinician-collected samples and patient-centric, self-collected vaginal or first-void urine samples. Self-sampling was preferred for comfort, though the study's single-centre setting may limit generalisability.
The OncoPredict HPV Quantitative Typing assay achieved clinical sensitivity ratios of 0.99 for urine and 1.00 for vaginal self-samples versus clinician-collected cervical samples for detecting CIN2+, and after cut-off optimisation showed similar accuracy on self-collected and cervical specimens, supporting decentralised cervical screening through urine self-collection with Colli-Pee.
Latsuzbaia et al., Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology (paywalled) · source ↗
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.
Pattyn et al., Journal of virological methods (paywalled) · source ↗