The Diassay hrHPV testBasic test principle The assay contains the following steps: 1. Amplifcation of viral DNA by established GP5+/6+ PCR; 2. Capture of biotinylated GP5+/6+PCR product in streptavidin-coated microtiter plates; 3. High stringency hybridization of PCR products with labelled hrHPV-specifc probes; 4. Detection of label by a conjugate, which is visualized by a substrate; 5. Measurement of optical density to determine the presence of hrHPV.
Characteristics • Intended for primary screening of risk to develop cervical cancer. • Well documented in large patients cohorts, peer reviewed, optimal sensitivity and specifcity. • Targets 14 hrHPV types covering 97.2% of global cervical cancer cases4. • CE certifed. • Established methodology. • The amplimers generated by this assay can be easily used for hrHPV genotyping5,6. Sensitivity and Specificity of Cytology and hrHPV GP5+/6+-PCR-EIA screening in women with documented cervical (pre-)cancer*