Comparison of six serum analyte workflows using routine liquid chromatography-tandem mass spectrometry methods at multiple laboratories with the Cobas i 601 analyzer, an automated mass spectrometry system

Abstract Objectives Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers substantial analytical advantages over traditional immunoassay methods, including greater specificity and robustness. Conventional LC-MS/MS methods are labor-intensive, requiring highly trained, dedicated laboratory staff. The Cobas ® i 601 analyzer (Roche Diagnostics International Ltd., Rotkreuz, Switzerland) is an automated, random-access, mass spectrometry (MS) system designed to improve workflows and reduce turnaround times. This study evaluated turnaround times for analyses with the i 601 analyzer vs. routine LC-MS/MS using batch processing. Methods We performed a workflow analysis for six sets of analytes (mycophenolic acid, antibiotics, antiepileptics, voriconazole, testosterone, and 25-hydroxyvitamin D) in seven laboratories across Europe, North America, and Asia. We recorded batch size, result turnaround times, and hands-on times (including quality control) for 93 batches analyzed on routine LC-MS/MS. These were compared to equivalent measurements generated using the i 601 analyzer in batch mode as part of a prototype pilot study at Ludwig Maximilian University, Munich. Results Turnaround times were shorter with the i 601 analyzer vs. routine LC-MS/MS for all tested workflows, independent of batch size and analyte workflow. Median time from batch start to final result availability with the i 601 analyzer was 6.8-fold shorter vs. routine LC-MS/MS (1 h, 34 min vs. 10 h, 37 min, respectively). In addition, median total hands-on time was 19-fold shorter with the i 601 analyzer vs. routine LC-MS/MS (5 vs. 93 min). Conclusions Compared with routine LC-MS/MS methods, the i 601 analyzer substantially reduced turnaround and hands-on times for common analytes, regardless of batch size.