MSACL 2026 Abstract

Clinical Implementation of the Roche Cobas I 601 at Scale

Russell P Grant, Meghan Norris Bradley, Matthew Chappell, Kristopher Huffman, Vicki Shields, Matthew L Crawford
Labcorp. Burlington, NC

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) Committee/Board/Advisory Board BCal Diagnostics Stock/Bonds Labcorp Salary Labcorp Discussing Products? NO, presenter will NOT present educational content related to products/services of the ineligible company(ies) listed above. Conflict mitigation NOT REQUIRED.

INTRODUCTION:
After a 10-year collaborative journey, Labcorp implemented the Roche Cobas® i601 for clinical testing to enable a seamless "sample-in, result-out" process in March 2026. Roche received FDA class 1 approval for the system and a number of analytes including Estradiol, Progesterone, 17-Hydroxyprogesterone, DHEA, DHEA Sulfate, Androstenedione and Total 25-Hydroxyvitmain D through 2026, enabling launch of these tests at clinical scale. This presentation will highlight the performance for multiple platforms and our experience in the transition from LDT LC-MS/MS to “core chemistry” workflows.

METHODS:
All Roche Cobas i601 measurements utilized the Roche CE-marked Ionify® reagent packs, calibrators, quality controls and corresponding instrument reagents. Comparison to the Labcorp LC-MS/MS measurements were performed with split-paired samples (3-130 ng/ml) on the same thaw cycle. External quality controls (Technopath) were used in conjunction with Validate LC/MS linearity materials provided by Roche.

PRELIMINARY DATA:
Following installation of the first two Cobas i601 units, validation studies for total and fractionated (25VitD3, 25 Vit D2) were performed and are summarized here. Inter-assay imprecision (n=21) using 4 levels of QC (Technopath + Roche, ~4, 8, 20 and 35 ng/ml) demonstrated imprecision < 4% for total and fractionated vitamin D measurements. Method comparison between the Labcorp LC-MS/MS LDT assay and both Cobas i601 systems resulted in Deming regression slopes ranging from 0.973 – 1.024 and correlation coefficients > 0.991 for both total and fractionated forms of vitamin D. Inter instrument agreement via Deming regression slope was between 0.973 – 1.016 with correlation coefficients > 0.998. Linearity assessment indicated slopes between 0.961 – 1.014 (range 3- 130ng/mL) for total and fractionated forms across 3 independent LC channels for both instruments. Carry-over was demonstrated to be < 0.01% (130ng/mL versus 20ng/ml). Comparison of throughput, analytical concordance to Labcorp LDT’s, system uptime and the implication for efficiency will be detailed using exemplar data across multiple assays within our install base.

NOVEL ASPECT:
Real-world experience implementing cobas i601 assays and systems at true clinical scale.