Dependable performance, dependable results
The cobas® HPV Test runs on the advanced cobas® 4800 System, which requires minimal maintenance and eliminates many manual steps for maximum lab efficiency.
The fully automated cobas® 4800 System is comprised of the cobas® x 480 Instrument and the cobas® z 480 Analyzer. The system utilizes a total nucleic acid isolation sample preparation method with real-time polymerase chain reaction (PCR) technology for amplification and detection.
cobas® 4800 System features and benefits:
Watch our video to see how easy it is to operate the cobas® 4800 System.
cobas® 4800 provides automated preparation
Primary vial post-cytology testing
The cobas® 4800 System uses primary vial post-cytology testing, which saves time and labor for transfer of sample. The primary cytology vial can be used to create cytology slides and then placed directly into the cobas® 4800 System for processing of the cobas® HPV Test, which eliminates the need for sample transfer to a secondary vial. Learn more about primary vial post-cytology testing.
Small 1mL sample size
Using a test with a small sample requirement helps eliminate the inconvenience of patient call-backs due to Quantity Not Sufficient (QNS) results from the laboratory.2
2 controls per run
Only 1 positive and 1 negative control is required per run of 24 or 96 samples, which provides confidence in results, while maximizing the number of patient reportables generated for clinicians.2
Consistently reliable results
Amplification and detection of HPV is reliable with the cobas® 4800 System’s expert software.
The cobas® 4800 System uses Polymerase Chain Reaction (PCR) technology, which has a proven track record as the right technology for molecular screening tests and has been utilized to establish the causal link between HPV and cervical cancer.
No grey zones, indeterminate results, or repeats required
The cobas® 4800 system utilizes a unique kinetic algorithm to eliminate the need for manual interpretation of results. The system simplifies test reporting by providing clear results (only positive, negative, and invalid) and no indeterminate results that would require repeat testing.2
No manual adjustment of clinical cutoffs
The cobas® 4800 System software does not allow manual adjustment of clinical cutoffs, which means labs don’t have to take on unnecessary risk by adjusting clinical cutoffs and deviating from FDA-approved test performance. The cobas® HPV Test performance is tied to clinically validated results from the ATHENA study.2
The cobas® 4800 System provides a high throughput and an efficient lab workflow from start to finish.
Minimal operator hands-on time
The cobas® 4800 System requires approximately 30 minutes of operator hands-on time to begin a run of 24 or 96 samples, which delivers maximum efficiency and allows laboratory staff to perform other valuable tasks.1
Minimal daily maintenance
The cobas® 4800 System requires minimal steps for daily maintenance, which does not need bleaching and typically involves just 2-7 minutes of operator time.1
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. 2011 Argent Global Services. Excludes Gen-Probe in comparison. Data on File.
2. cobas® HPV Test [package insert, US]. Branchburg, NJ: Roche Molecular Systems, Inc; 2016