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    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

cobas® 4800 System

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: 

  • Direct loading of primary vials onto system
  • Requires as small as 1 mL sample size 
  • Requires only 2 controls per run  
  • Does not permit manual adjustment of clinical cutoffs, validating test performance 
  • Easy-to-learn software that walks user through the entire setup process
  • Fewer than 40 minutes of operator hands-on time per run of 24 or 96 samples1 
  • Only 2-7 minutes needed for daily maintenance with no bleaching required1 
  • Runs both the cobas® HPV Test and cobas® CT/NG test. See full system test menu

 

Watch our video to see how easy it is to operate the cobas® 4800 System.

cobas® 4800 System

Streamlined design helps save time and resources.

Sample Preparation

cobas 4800 System Vials

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

Test Analysis

Consistently reliable results

Amplification and detection of HPV is reliable with the cobas® 4800 System’s expert software. 

PCR technology 
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

Simplify workflow efficiency with the cobas® 4800 System.  

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  

Remote diagnostics

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.

  • Acronyms:

References:

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