Roche has received the U.S. Food and Drug Administration (FDA) approval for a new, more efficient workflow process for the cobas HPV Test, allowing sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing.
This will allow labs to load the vial used for a ThinPrep Pap test directly onto Roche’s cobas 4800 System for high-risk HPV (Human Papillomavirus) and individual HPV 16 and 18 genotype testing, which helps in identifying women who are at risk for cervical cancer.
Roche Diagnostics chief medical officer Dr. Alan Wright said with new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly.
"Giving labs the option to use the same primary vial from a Pap test for HPV testing lets them eliminate a complete step in their workflow process and lower the risk of errors in sample handling, helping to ensure that patients receive accurate test results," Wright added.
Utilising a special primary vial rack for the completely automated cobas 4800 System, the new process removes the requirement for lab technologists to pipette samples from the primary vials, which are used for liquid-based cytology, into a separate tube.
They can load the same vial onto the cobas 4800 System directly after cytology processing. The streamlined workflow also helps labs in slashing costs, boost turnaround time and allow staff to invest their time on other critical tasks.
The cobas HPV Test is claimed to be the first HPV test to receive FDA approval for loading a Pap sample vial directly onto an automated system and for the use of primary vial samples after cytology processing on either the ThinPrep 3000 (T3000) system or the ThinPrep 2000 (T2000) system.