Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

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Aim: Compare the clinical sensitivity and specificity of Abbott RealTime High Risk HPV assay (Abbott GmbH, Wiesbaden, Germany) of Colli-Pee® collected first void-urine to matched clinician-taken samples in a colposcopy referral population 

Partners: Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Laboratory of Molecular Pathology, AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, International Centre for Reproductive Health, Ghent University, Department of Obstetrics and Gynaecology, General Regional Hospital Heilig Hart, Femicare vzw, Clinical Research for Women, Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Department Gynaecology-Obstetrics, University Hospital Liège, Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Molecular Imaging, Pathology, Radiotherapy, Oncology (MIPRO), Faculty of Medicine and Health Sciences, University of Antwerp, Department of Obstetrics and Gynecology, Ghent University Hospital 

Summary: Nearly all cervical cancers are caused by a persistent cervical infection with a high-risk Human Papillomavirus (hrHPV). Despite the benefits of screening in reducing disease incidence and mortality, participation remains low in many countries.  Urine self-sampling for HPV detection has gained increasing interest for cervical cancer screening and has potential to screening uptake. However, data on the clinical accuracy of hrHPV detection in urine used in population-based screening settings has been limited.  

For this reason, the VALHUDES study was initiated, which aimed to assess the sensitivity and specificity of particular hrHPV assays in vaginal self-samples as well as first-void urine compared to matched physician-taken samples.  Today the results of a study, following the VALHUDES protocol, demonstrate that hrHPV testing with Abbott RealTime High Risk HPV assay on first-void urine collected at home using Colli-Pee® containing urine conservation medium (UCM) (Novosanis, Wijnegem, Belgium) shows similar accuracy for detecting CIN2+ compared to cervical samples taken by a clinician. This is the first study to prove that HPV testing in home-collected first-void urine is a valid alternative to cervical samples. 

 The results are pivotal to increase sampling strategies and reach women who do not participate in traditional screening programs by offering urine self-collection at home. Additionally, considering the impact of COVID-19, where standard care is suspended, offering at home self-sampling could facilitate timely screening and re-testing, yet reducing the burden on health care personnel and spread of the virus. 

 

Read the full publication here: 

Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol