HPV-Risk assay clinically validated on SurePath cervical screening samples
Within the VALGENT framework, a clinical validation of the HPV-Risk assay on SurePath cervical samples (i.e., VALGENT-4) has been conducted (Heideman et al, Journal of Clinical Virology 2019). The VALGENT framework is designed for comparison and clinical validation of HPV assays. The study report describes the evaluation of the accuracy of the HPV-Risk assay relative to clinically validated comparator HPV tests, GP5+/6+-PCR-EIA and GP5+/6+-PCR-LMNX. The HPV-Risk assay demonstrated non-inferiority to the clinically validated comparator assays in SurePath medium using the VALGENT-4 panel . Results from this study verify that the HPV-Risk assay can be applied in primary cervical cancer screening using SurePath collection medium.