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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Van Keer et al., 2021
Aim: Compare the clinical sensitivity and specificity of of Colli-Pee® collected first void-urine to matched clinician-taken samples in a colposcopy referral population with Abbott RealTime High Risk HPV assay (Abbott GmbH, Wiesbaden, Germany)
Affiliations: (University Hospital of Antwerp (UZA), Brussels (UZ Brussels), Ghent (UZ Ghent), Liège (CHU de Liège), and the General Regional Hospital Heilig Hart Tienen (RZ Tienen)
Summary: The study revealed similar clinical sensitivity (CIN2+) and specificity (<CIN2) of high-risk HPV testing with the Abbott RealTime High Risk HPV assay to detect cervical cancer lesions on first-void urine samples collected at home using Colli-Pee Colli-Pee® compared to cervical samples collected by a clinician. This comparable clinical accuracy was observed in the total study population (493 women aged 19 to 72 years), as well as for women 30 years and older.