Ushering in a new era of automation
The early days in molecular diagnostics
Kary Mullis’ 1983 discovery of the polymerase chain reaction (PCR) was an integral step in the birth of molecular diagnostics. In recognition of his work, Mullis was awarded the Nobel Prize for Chemistry in 1993. This DNA ‘photocopier’ in a test tube allowed PCR and other nucleic acid amplification testing (NAAT)-based techniques to quickly become commonplace in laboratory medicine.1-5
The following decades introduced new techniques to speed up PCR through automation, and allowed for the development of today’s generation of rapid, precise, multiplex PCR detection instruments.
The need for automated solutions
Today’s molecular diagnostic laboratories are faced with a daunting set of challenges—increasing testing volumes, expanding assay menus that demand quality results, and a need to enhance productivity while ensuring cost savings.
To answer these challenges, molecular laboratories are following the lead of clinical chemistry labs by prioritising the transition towards total laboratory automation.
- Through linking the modules of track-enabled systems via the laboratory information system (LIS), patient samples are moved from initial arrival in the laboratory, all the way through to automatically releasing results to clinicians6
The development of most molecular IVD tests, however, has for a long time centered on the assay and testing system itself without much focus on integrating it into the laboratory workflow.
Universal concept design of cobas® 6800/8800 Systems
Previous PCR systems automated several different aspects of the sample-to-result continuum with varying degrees of automation and flexibility. The cobas® 6800 System and cobas® 8800 System are designed to improve process consistency and increase efficiency through full workflow automation.
- Accommodating multiple types of assays in a much more flexible and automated manner
- Improving testing turnaround times, efficiencies, and traceability
- Utilising the universal sample preparation process and reagents, total nucleic acids are isolated, purified, and extracted in the sample processing module, eliminating the need for separate RNA or DNA isolation
Efficiency and standardisation
Automation significantly improves utilisation of skilled technicians and helps reduce cost.6-8
- In an 8-hour shift, the cobas® 6800/8800 Systems can process up to 384 and 960 samples, respectively
- The systems automatically and efficiently run and process samples with no presorting or test batching required
- Up to 12 assay-specific reagent cassettes can be loaded on board at a time
- Fully automated workflows reduce hands-on time
- Reduced square footage and freezer refrigerator space required for storage
A new way to interface with automation with cobas p 312/512/612 pre-analytical systems
The cobas® 6800/8800 Systems help laboratories integrate and automate their overall workflow, connecting with pre- and post-analytic solutions. The broad menu helps consolidate their tests on a high throughput, fully automated system.
Simplified assay development
The cobas omni Utility Channel for use on the cobas® 6800/8800 Systems offers laboratories the ability to develop and validate their own laboratory developed tests (LDTs).**
- The consolidation and full automation of IVD and LDTs on one platform helps make the most out of a laboratory’s footprint, minimise upfront capital investment, and decrease operational costs*
Efficiency gains across healthcare
Automated platforms increase clinical value delivered to stakeholders across the continuum of healthcare.
The new industry standard
Molecular diagnostics are a key component of laboratory medicine, and PCR is a prime driver of this dynamic. Delivering absolute automation, unmatched flexibility, and unparalleled performance, the cobas® 6800/8800 Systems are the most advanced exponents of PCR to date.
As the most innovative molecular diagnostics systems on the market, the cobas® 6800/8800 Systems will transform the way molecular labs think and work, and are a true representation of the future of molecular testing.
The cobas omni Utility Channel is not available in all markets.
*IVD and LDT samples are run on separate cobas omni Processing Plates.
**Research Use Only in the US.
- Mullis KB, Faloona FA. Specific synthesis of DNA in vitro via a polymerase-catalyzed chain reaction. Methods Enzymol. 1987;155:335-350.
- Salki RK, Bugawan TL, Horn GT, et al. Analysis of enzymatically amplified beta-globin and HLA-DQ alpha DNA with allele-specific oligonucleotide probes. Nature. 1986;324(6093):163-166.
- Salki RK, Gelfand DH, Stiffel S, et al. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988;239(4839):5.
- Mullis, KB. The unusual origin of the polymerase chain reaction. Sci AM. 1990;262(4):56-61, 64-55.
- Mullis, KB. Target amplification for DNA analysis by the polymerase chain reaction. Ann Biol Clin (Paris).1990;48(8):579-582.
- Melanson SE, Lindeman NI, Jarolim P. Selecting automation for the clinical chemistry laboratory. Arch Pathol Lab Med. 2007;131(7):1063-1069.
- Streitberg GS, Angel L, Sikaris KA, et al. Automation in clinical biochemistry: core, peripheral, STAT, and specialist laboratories in Australia. J Lab Autom. 2012;17(5):387-394.
- Zaniotto M, Plebani M. The ‘hospital central laboratory’: automation, integration and clinical usefulness. Clin Chem Lab Med. 2010;48(7):911-917.