Roche's Cobas HPV test identifies DNA from 14 high-risk HPV (HR-HPV) types commonly associated with cervical cancers, including the identification of HPV types 16 and 18, the two most common types of HPV infections. They account for approximately 70% of all cervical cancers.
The fully automated test utilizes cervical specimens collected in liquid-based cytology vials. The test is based on two major processes:
- Automated specimen preparation to simultaneously extract HPV and cellular DNA and
- PCR amplification of target DNA sequences using HPV and β-globin-specific complementary primer pairs and real-time detection of cleaved fluorescent-labeled HPV and β-globin-specific oligonucleotide detection probes.
The master mix reagent for the Cobas HPV Test contains primer pairs and probes specific for the 14 HR-HPV types and β-globin. Results are simultaneously reported as positive or negative for the pooled 12 HPV types (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68) from channel 1, with HPV16 and HPV18 genotypes read individually from channels 2 and 3. A fourth channel detects the human β-globin gene as a control for sample adequacy and assay inhibition.
