Full-molecular automated cervical screening is now possible combining the objectivity, reproducibility and high-throughput aspects of both the HPV-Risk Assay and the QIAsure Methylation Test.
The HPV-Risk Assay is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA, targeting the E7 region of the following 15 (probably) high-risk HPV genotypes, i.e., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68.
The automated workflow on the NeuMoDx™ 96 and 288 Molecular Systems include DNA extraction, PCR amplification, fluorescent detection and result calculation.
The analytical and clinical validations are performed according to the International “Meijer” HPV DNA Test Guidelines.
The QIAsure Methylation Test is a real-time PCR-based molecular assay to distinguish women with cervical (pre)cancer. The QIAsure Methylation Test specifically detects women with a cancer-like methylation profile that have a short term high risk for progression to cervical cancer.