Built-in Quality Control: Utilizes an internal control targeting the human β-globin to differentiate true negative results from invalid ones caused by PCR inhibitors or insufficient cellular mass
Contamination Control: The master mix incorporates dUTP and the AmpErase enzyme, which enzymatically degrades contaminating amplicons from previous PCR runs during the initial heating step to prevent carry-over contamination.
Fully automated, qualitative in vitro diagnostic assay utilizing real-time PCR and nucleic acid hybridization.
End-to-End Automation: Seamlessly operates on the cobas® 5800, 6800, and 8800 systems.
Genotyping & Risk Stratification: Detects 14 high-risk HPV types in a single run. It uniquely provides individual genotyping for HPV 16 and HPV 18 while concurrently reporting the pooled result of 12 other HR-HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66,and 68).
Specimen Versatility: Broad specimen compatibility, including support for healthcare worker-instructed vaginal self-collection to maximize screening accessibility.
Clinical Applications Uses : First-Line Primary Screening: Serves as a standalone primary test to identify women at high risk for cervical cancer or high-grade lesions, driving a proactive prevention strategy. ASC-US Triage: Screens patients with ASC-US in cytology to determine the necessity of colposcopy referral. Co-Testing: Used adjunctively alongside routine cytology to assess the presence or absence of HR-HPV genotypes.
Roche Molecular Systems, Inc.
