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.

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