MSACL 2025 Abstract

Unmasking the Mystery Machine: Evaluation of the Roche Cobas i 601 Analyzer

Russell P Grant (1), Matthew Chappell (1), Meghan Norris Bradley (1), Matthew Crawford (1), Sven Groesgen (2), Philippe Metz (2)
(1) Labcorp, Burlington, NC, (2) Roche Diagnostics GmbH, Mannheim, Germany

Russell Grant, PhD (Presenter) Labcorp

Presenter Bio: Dr. Grant earned a first-class honors degree in Industrial Chemistry from Cardiff University and a PhD in Chromatographic and Mass Spectrometric technologies from the University of Swansea, Wales, United Kingdom. He continued his scientific training in various industrial settings, which have included senior scientist at GSK, Principal scientist at Cohesive Technologies, Technical director at Eli Lilly, and Director of Mass Spectrometry at Esoterix Endocrinology. Dr Grant is currently the Vice President of Research and Development and co-discipline director for Mass spectrometry at Labcorp. Dr Grant has pioneered the use of direct injection technologies, chromatographic systems multiplexing, microsampling, utility of automation, and other new analytical platforms in direct patient care. His research goals are focused upon improvements in speed, sensitivity, and quality of liquid chromatography with tandem mass spectrometric (LC-MS/MS) analytical systems and assays. Dr Grant has been awarded 100 patents and received both the MSACL Distinguished contribution award and ASMS AL Yergey “Unsung Hero” Award in 2024 for his contributions to Clinical Diagnostics using Mass Spectrometry.

Relevant Financial Disclosures (within past 24 months, reported on Apr 23, 2026) Other Potential Conflicts HepQuant / Consultant LabCorp / Stock LabCorp / Salary Discussing Products? YES, presenter will present educational content related to products/services of one or more ineligible company(ies) listed above. All relevant financial relationships have been MITIGATED.

INTRODUCTION:
The evolution of clinical LC-MS/MS lies in fully automated and integrated instrumentation. The Roche Cobas® i601 analyzer merges sample preparation and LC-MS/MS analysis into a seamless "sample-in, result-out" process. This development enables high-quality LC-MS/MS data in clinical labs without specialized training. Efficiency gains through random access, auto-dilution, and parallel processing/analysis will be highlighted. The system's accessibility, intuitive troubleshooting, and data quality flags will also be discussed. An example dataset for androstenedione in human serum will be presented, showcasing imprecision, accuracy to a CAP/CLIA validated lab-developed LC-MS/MS assay and external NIST traceable reference materials, among other analytical characteristics.

METHODS:
All experiments utilized the Roche CE-marked Ionify® Steroids 1 reagent pack, calibrators, quality controls, and corresponding instrument reagents. The integrated system features a parallelized sample preparation module, adding isotopically labeled androstenedione prior to adding pretreatment reagent. Antibody-functionalized paramagnetic beads facilitate purification ahead of LC-MS/MS analysis in a parallel multiplexed chromatographic system linked to a triple quadrupole mass spectrometer. Analytes and internal standards are detected via multiple reaction monitoring. Chromatograms are automatically assessed for peak quality prior to integration. Measurement results are calculated based on a leading calibration adjusted by instrument-specific 2-point calibration.

PRELIMINARY DATA:
In single-analyte batch analysis mode, the Cobas® i 601 analyzer, operating at a throughput of 100 results per hour, demonstrated a 400% increase in efficiency compared to the LDT. Reanalysis with on-board auto-dilution was successfully implemented for samples with concentrations exceeding the upper limit of the analytical measurement interval. This enhancement can reduce the turn-around time by more than one day for obtaining patient results. Method comparison to the validated LC-MS/MS assay yielded a Deming regression slope of 1.033, a correlation coefficient (R) of 0.9995, and a mean bias of 1.997%. Analysis of NIST traceable external materials showed a mean bias of -1.6%. Intermediate precision, conducted per CLSI-EP5 guideline (2 replicates, 2 times a day, over 20 days), was performed over 29 days without recalibration from day one. This involved two manufacturer controls and five pooled patient samples, resulting in Coefficients of Variation (CV) ranging from 2.1% to 3.0%. Total imprecision based on a 5 replicates/5 days experiment yielded CVs between 2.0% and 4.9%. Instrument and analytical robustness were demonstrated by analyzing matched sample aliquots under three stressed conditions and comparing them by Deming regression to batch mode analysis on day one calibration. When compared to batch mode analysis, results generated from random access analysis resulted in a slope of 1.010, an R-value of 0.9998, and a mean bias of 1.114%. Results from an alternate reagent lot yielded a slope of 1.002, an R-value of 0.9995, and a mean bias of 0.811%. Finally, results generated 28 days after initial calibration yielded a slope of 1.003, an R-value of 0.9995, and a mean bias of 0.432%. Blood-based interferences such as hemolysis, lipids, and bilirubin were shown to be acceptable, with supraphysiological concentrations tested as defined by CLSI-EP7 and EP37. The bias in the presence of any given interferent was less than 5%.

NOVEL ASPECT:
Fully integrated and automated LC-MS/MS system including sample extraction and LC-MS/MS data for clinical labs with minimal training for staff.

DISCLAIMER:
Cobas i 601 analyzer and Ionify Steroids 1 and Vitamin D reagent packs are CE-marked. Further Ionify reagents are still under development. These products are not cleared or available for use in the US. COBAS and IONIFY are trademarks of Roche. This study was funded by Roche Diagnostics GmbH.