• The assays is clinically validated and demonstrates good clinical performance compliant to the International Guidelines (also known as the Meijer criteria) on clinical sensitivity, clinical specificity and intra and inter laboratory performance. The clinical sensitivity and specificity for CIN2+ were non-inferior to that of the reference assay GP5+/6+, indicating a very good clinical performance.

• The assay targets the E7 region of the HPV genome, a region which is always retained in cervical cancer. Thereby potential false-negative results due to the effects of viral integration, a process that is often associated with malignant progression, are prevented. As viral integration causes interruption of the viral genome in a region from the E1 to the L1 ORF it can only affect assays targeting within this region like L1-based PCR detection assays.
• The most abundant and carcinogenic genotypes HPV16 and HPV18 are reported separately from non-HPV 16/18 high risk types.
• An internal sample control checks for sample quality, assuring reliable results.
• Beyond cervical scrapes, it performs well on a large variety of different sample specimens. The assay is successful validated in the VALGENT-3 and VALGENT-4 studies against the reference assays GP5+6+ and hc2 for several preservatives such as PreservCyt and SurePath. In addition it is also validated for self-samples (brush and lavage) and can be used for detection of HPV in formalin fixed paraffin embedded (FFPE) specimens.
• The HPV Risk Assay is compatible with the following real time PCR platforms: RotorGeneQ and Mic qPCR Cycler, and Biorad CFX, ABI7500 and VIA7.

Workflows
DNA extraction for the HPV-Risk assay can be performed fully automated using the QIAsymphony® DSP Virus/Pathogen Midi Kit including PCR set up, or semi-automated using the NucleoMag 96 Tissue kit from Macherey-Nagel (can be performed on several 96 well liquid handlers), but also manually using standard DNA extraction kits (e.g., column- and magnetic bead-based kits, such as QIAamp® DSP virus spin kit).