Hiroshi Mitsumaki

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, 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 rack transportation 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). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were 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 less than 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 routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

Modularized system architecture for flexible clinical laboratory systems

The increase in medical expenses resulting from longer life expectancy is an increasing serious social problem in Japan. Reducing the cost of clinical laboratory systems, increasing quality of service to patients, and safeguarding the health of hospital staff are important issues for hospitals. A flexible clinical laboratory system is needed to reduce system development cost. Automated clinical laboratory systems, for large and small hospitals alike, are needed in order to reduce waiting time and the risk of workers being exposed to infectious diseases. Flexible systems could meet all these needs. We have developed a modularized system architecture to provide a flexible clinical laboratory system. The hardware and software of the clinical and sample transfer equipment are modularized in this system. Each piece of equipment can autonomously decide where to transfer samples and how to process them. The clinical equipment works autonomously and can be added or suspended without influencing the other equipment. The transfer equipment is also autonomous, and the sample transfer lines can be changed easily in accordance with space limitations. We applied this modularized system architecture to a pre-analytical sample-handling system, and demonstrated its effectiveness. This system was developed by using equipment from different vendors, thus demonstrating that such a system can be easily built.