Dedicated Assays and New Instruments Automate PCR Diagnostic Applications

Two new diagnostic instruments, which recently were certified for marketing in Europe, will bring an unprecedented level of automation and efficiency to laboratories that process large and very large numbers of specimens on a daily basis.

The Roche Molecular Diagnostics (Pleasanton, CA, USA) cobas 6800/8800 system automates PCR technology for virology (HIV-1 Group M, HIV-1 Group O, HIV-2, HCV, HBV, and West Nile virus), blood screening, HPV (human papillomavirus), and CT/NG (Chlamydia trachomatis and Neisseria gonorrhea) testing.


The system comes in two sizes: large (6800) and very-large (8800) throughput capacity, and was developed to deliver increased automation and throughput, with minimal user intervention and improved quality control.

The instruments are equipped with an onboard refrigerator to allow for significantly longer reagent storage capacity and less loading and unloading of reagents. The system design provides greater ergonomics in terms of the user-instrument interface, reducing the number of required user interactions. Once the instrument is loaded, the system can run continuously for four or eight hours for the cobas 8800 and cobas 6800 system, respectively. Once the instrument begins processing samples, the first 96 results can be reported within three-and-a-quarter hours. Thereafter, the Cobas 6800 and 8800 instruments provide up to 96 results every 90 or 30 minutes, respectively.

This level of efficiency was obtained by completely automating the processing of primary and secondary tubes all the way through to the patient sample result for any combination of three different tests at the same time. This parallel sample to result process is accomplished using a universal sample preparation, PCR profile, and reagent setup process. Extraction and purification of nucleic acids from input samples takes place in the processing module. The purified nucleic acids are then transferred to amplification plates, along with test-specific amplification master mixes to prepare the plates for amplification and detection in the analytical modules. The inventory manager houses all reagents, controls and consumables necessary to achieve complete automation. The analytical module performs the automated amplification and detection of target nucleic acids using real-time PCR technology.

“The cobas 6800/8800 Systems represent a new class of molecular diagnostic instruments,” said Roland Diggelmann, COO of Roche Diagnostics. “Over the last several years, we have collaborated with top industry leaders and several hundred customers to design a platform that truly meets the evolving needs of the molecular diagnostics laboratory. These systems will set new industry standards with technical innovation for throughput, speed-of-results, automation and flexibility that have not been seen before in a molecular diagnostic system. We are proud of the benefits they will bring to people and the healthcare environment.”

The cobas 6800/8800 Systems are now available in all markets in Europe, Latin America, the Middle East, Africa, and Asia that recognize the CE-mark.

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Roche Molecular Diagnostics