The cobas® 6800/8800 System: a new era of automation in molecular diagnostics

ABSTRACT

Introduction: Molecular diagnostics is a key component of laboratory medicine. Here, the authors review key triggers of ever-increasing automation in nucleic acid amplification testing (NAAT) with a focus on specific automated Polymerase Chain Reaction (PCR) testing and platforms such as the recently launched cobas® 6800 and cobas® 8800 Systems. The benefits of such automation for different stakeholders including patients, clinicians, laboratory personnel, hospital administrators, payers, and manufacturers are described.

Areas Covered: The authors describe how molecular diagnostics has achieved total laboratory automation over time, rivaling clinical chemistry to significantly improve testing efficiency. Finally, the authors discuss how advances in automation decrease the development time for new tests enabling clinicians to more readily provide test results.

Expert Commentary: The advancements described enable complete diagnostic solutions whereby specific test results can be combined with relevant patient data sets to allow healthcare providers to deliver comprehensive clinical recommendations in multiple fields ranging from infectious disease to outbreak management and blood safety solutions.

KEYWORDS:

• Nucleic acid amplification testing
• polymerase chain reaction
• laboratory automation
• infectious diseases
• blood product safety
• assay development
• diagnostic solutions
• patient management
• outbreak management

Acknowledgments

The authors thank Susan Galel, Ellen Paxinos, John McCune and Aaron Nelson for carefully reviewing the manuscript. They also thank Isabel Ross and Joni Zurawinski for assistance with reviewing the figures and tables.

Declaration of interest

B. Cobb, O. Liesenfeld, C.O. Simon, N. Reisch and S. Will are employees of Roche Molecular Diagnostics. S.L. Stramer has received research support and honoraria from Abbott, Cerus, Grifols, Hologic, and Roche. Her lab also receives federal funding (FDA and NHLBI). S.L. Stramer was a member of customer advisory boards for Roche Molecular Diagnostics, including a user group that participated in making recommendations on design and functionality of the 6800/8800. B. Body was a member of customer advisory boards for Roche Molecular Diagnostics, including a user group that participated in making recommendations on design and functionality of the 6800/8800. She has served as PI for studies that led to FDA clearance of the instrument use for diagnosis of blood borne virus infection. She has received no compensation for these efforts. She is an employee and officer of Laboratory Corporation of America, Holdings. P.S. Mitchell was a member of a customer advisory board (CAB) for Roche Molecular Diagnostics making recommendations on design and functionality of the 6800/8800 instrumentation. He has received no compensation for these efforts. S. Carmona has served as PI for studies that evaluated the performance of 4 generations of Roche Molecular Diagnostics HIV-1 assays routinely used for viral load monitoring which included cobas HIV-1. Roche Molecular Diagnostics provided the material and partially covered laboratory personnel cost to conduct the study. He has received no personal compensation for these efforts. He is an employee of the National Health Laboratory Service, South Africa. L. Katz has received consulting fees and/or research support from Abbott, Terumo BCT and Ortho Clinical Diagnostics, and was a member of customer advisory boards for Roche Molecular Diagnostics, including a user group that participated in making recommendations on design and functionality of the 6800/8800. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was funded by Roche Molecular Systems.