2023 · The Journal of molecular diagnostics : JMD · paywalled
Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol
Latsuzbaia et al.
The finding, in our words
In a colposcopy referral population, the Alinity m HR HPV assay showed similar sensitivity for CIN2+ on home-collected first-void urine and vaginal self-samples compared with clinician-collected cervical samples, with comparable specificity for first-void urine and variable specificity across vaginal devices; adjusting signal thresholds improved assay accuracy across all self-sample types.
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.