The cobas® 4800 HPV Test is performed on the cobas® 4800 System, which offers true walk-away automation of nucleic acid extraction and purification, as well as polymerase chain reaction (PCR) technology setup, amplification and detection. The cobas® 4800 System uses easy-to-use software that seamlessly integrates the process and data interpretation analysis to help laboratories achieve maximum efficiency.
The cobas® 4800 System is comprised of the cobas® x 480 Instrument and the cobas® z 480 Analyzer.
Sample preprocessing prior to cobas® 4800 System analysis can be automated with the addition of a cobas® p 480 instrument into the workflow. The cobas® p 480 instrument takes care of primary vial decapping, vortexing, and recapping, eliminating hands-on time and reducing risk of repetitive motion injury for laboratory staff.
The cobas® 4800 System’s streamlined workflow helps laboratories:
Watch our video to see how easy it is to operate the cobas® 4800 System.
cobas® 4800 System offers efficient sample processing.
Primary vial testing
The cobas® 4800 System uses primary vial testing, which saves time and labor for transfer of sample. Specimens can be processed directly from liquid-based cytology (LBC) vials, eliminating the need to transfer aliquots to a secondary vial.
Small 1mL sample size
Using a test with a small sample requirement reduces non-reportable results and the inconvenience of patient call-backs due to insufficient sample volume
2 controls per run
Only 1 positive and 1 negative control is required per run, which provides confidence in results, while maximizing the number of patient reportables generated for clinicians.1 Other tests require as many as 8 calibrators and controls.
Consistently Reliable Results
Real-time polymerase chain reaction (PCR) technology
The cobas® 4800 System uses polymerase chain reaction (PCR) technology, which is most proven for molecular screening tests. PCR was used to establish the causal link between HPV and cervical cancer and its performance was clinically validated by the landmark ATHENA trial.
No grey zones, indeterminate results, or need for repeat testing
The cobas® 4800 System utilizes a unique proprietary kinetic algorithm, which is based on 15 years of clinical experience. The system manages result calculations and eliminates the need for manual interpretation, giving precise answers and reporting only positive, negative, or invalid result options.
Free staff for other critical tasks
Minimal hands-on time2
Overall and per reportable, the cobas® 4800 System requires the least amount of hands-on time, resulting in the lowest labor time for laboratories.
Improve turnaround time
The cobas® 4800 System requires less than 20 minutes of setup time for 94 specimens and can process up to 384 samples per day on a single system.
Least time required for daily maintenance2
The cobas® 4800 System requires the lowest daily maintenance among all competitors analyzed, taking only 4 minutes/day. It is also the most convenient of all systems analyzed, as it doesn’t require post-run decontamination cleanup of the workstation or other areas as required by other systems.
Connectivity to laboratory information systems
No manual scanning of tubes is required to operate the cobas® 4800 System. The user can load a run (samples, reagents, disposables) in just 10 minutes.
System test assays include HPV, CT/NG, and Genomic and Oncology
The cobas® 4800 System’s expanding test menu enables broader use of the cobas® 4800 System, allowing your laboratory to maximize its investment and potentially save money. Every Roche assay is based on our PCR strength and legacy, extensive test design and optimization experience, and commitment to robust performance standards. See full system test menu.
Roche’s remote diagnostics support provides enhanced service and technical support through a secure web connection for streamlined troubleshooting. This allows for quick assessment of both system and software status, minimizes technical support phone time for laboratory staff, and enables electronic transfer of data, eliminating the need to fax data or message logs when troubleshooting.
1. cobas® HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.
2. Data on file, Cobas® 4800 Competitive Laboratory Efficiency Analysis. April 2012.