The next-generation Hybrid Capture® High-Risk HPV DNA assay on a fully automated platform

ABSTRACT Background A next-generation diagnostic system has been developed at QIAGEN. The QIAensemble™ system consists of an analytical subsystem (JE2000™) that utilizes a re-engineered Hybrid Capture® chemistry (NextGen) to maintain the high level of clinical sensitivity established by the digene High-Risk HPV DNA Test® (HC2), while creating improved analytical specificity as shown both in plasmid-based analyses and in processing of clinical specimens. Study Design Limit-of-detection and cross-reactivity experiments were performed using plasmid DNA constructs containing multiple high-risk (HR) and low-risk (LR) HPV types. Cervical specimens collected into a novel specimen collection medium, DCM, were used to measure stability of specimens, as well as analytical specificity. Signal carryover, instrument precision, and specimen reproducibility were measured on the prototype JE2000 system using the automated NextGen assay. Results The Limit of Detection (LOD) is