A structured productivity challenge study of a fully automated mass spectrometry system

The Roche Cobas^® i601 is a fully automated mass spectrometry analyzer designed for 24 h random-access operation in routine medical laboratories. We aimed to systematically assess its throughput, robustness, and precision - along with its ease of use and walk-away time - within a high-volume clinical laboratory setting using the first commercially available reagents.

A panel of 13 measurands, implemented across three different reagent configurations (i pack Ionify^® reagents: Ionify steroids 1, Ionify steroids 2, Ionify vitamin D 25 and 24,25), was quantified using aliquots of three human serum pools. Identical series layouts were applied across four study days. After loading reagents, consumables, and samples and initiating the respective series, no further operator intervention was required until completion of the run.

Across the four series, a total of 3,016 valid quantitative results were generated. Each series was completed within 6 h without operator intervention, corresponding to the minimum observed walk-away time. This equates to an average throughput of 119 analyses per hour. Analysis of the human serum pools demonstrated coefficients of variation (CVs) below 4 % (with few exceptions).

Under a high-throughput evaluation protocol in a routine clinical laboratory setting, the fully automated MS methods demonstrated performance and productivity characteristics consistent with the manufacturer's representative data, particularly with regard to calibration stability, precision, analytical throughput, and walk-away time.