MODULARANALYTICS: A New Approach to Automation in the Clinical Laboratory

摘要

MODULARANALYTICS(Roche Diagnostics) (MODULARANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack racktransportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULARANALYTICSallows customised configurations for various laboratory workloads. The performance and practicability of MODULARANALYTICSwere evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically lessthan 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routineinstrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULARANALYTICS, which offered over 100 possible methods, with reduction in samplesplitting, handling errors, and turnaround time. Typical sample processing time on MODULARANALYTICSwas less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULARANALYTICSmet diverse laboratory needs and offeredimprovement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.