By Louise Lazear
A new analyzer provides high-throughput clinical chemistry and immunoassay testing on one platform
Today’s clinical laboratorian is in the rather enviable position of experiencing first hand a rapid acceleration in the pace of technology development. New assays along with the changing role of the laboratory as information manager and provider means increasing workloads, all in the context of an ever-dwindling workforce. Despite significant advances in throughput due to process enhancements and the increasing availability of automation, some procedures inherent to assay type and sample handling simply just take time. And in today’s laboratory environment, time is a coveted commodity.
Realizing the impact of this confluence of forces upon the laboratory, manufacturers have focused on various ways to help their customers address these issues. Based on input from the laboratory community, Roche Diagnostics has developed a solution called Integrated Modular Analytics, a new analyzer that takes the concept of technology integration within the laboratory to the next level. By combining clinical chemistry and immunoassay analysis onto a single platform, this system will enable laboratories to process 90 percent of patient samples in one pass, with one sample input using a single operator interface.
“Our design process began several years ago as customers became even more concerned about critical labor shortages and the impact of new assays on workloads. Our customers also emphasized the need to reduce turn-around times, along with a desire to have access to as many on-board assays as possible. After a careful analysis of the types of assays performed by the clinical laboratory, our approach was to develop a new system that provided consolidation of our existing technologies onto a single platform, coupled with a major reduction in operator intervention,” said Lisa Davis, product manager at Roche.
Prior to release, the Integrated Modular Analytics system underwent rigorous evaluation at several facilities globally, including the clinical chemistry laboratory at Beth Israel Deaconess Medical Center. Here, laboratorians performed an analysis of laboratory workflow of 600 patient samples for which 4,000 tests were ordered. Assays were performed using their existing workflow and instrumentation scenario, and were duplicated on the Integrated Modular Analytics platform. A comparison of the workflows under the two scenarios demonstrated a significant decrease in mean turnaround time with assays performed on the new system, from 3.5 hours to less than 30 minutes. Of even greater interest to the researchers was the enormous reduction in handling time, from 12 hours down to two hours using the integrated system. This reduction in handling was directly linked to the fact that the new analyzer performed several assays from one sample, in one pass, eliminating the processing steps and lag time associated with moving samples to various platforms.
Time savings of this magnitude can provide obvious advantages to laboratories of all sizes. According to Davis, Roche’s design philosophy was driven by a desire to maximize available expertise as efficiently and productively as possible, rather than reducing FTEs. “One of our evaluators commented that the real beauty of the system is its ability to simplify routine workflows. By eliminating many of the time-consuming sample process and handling tasks that take up so much of their day, laboratorians are now able to focus on other more challenging aspects of their work. In this sense, our Integrated Modular Analytics platform offers a career path within the laboratory, allowing staff the time to add new assays and explore new technologies,” said Davis.
Roche’s integrated system incorporates technology from both the immunoassay and clinical chemistry product families. According to Davis, a key feature of the integrated platform is the use of their electrochemiluminescence (ECL) technology for immunoassay methods. “Roche’s ECL technology is a very sensitive technique that provides a broader measuring range than some other available immunoassay methods. What we have been able to do with this new analyzer is simplify immunoassay testing while providing synergy with clinical chemistry.”
The Integrated Modular Analytics platform combines three ISEs with a reagent capacity of up to 44 photometric and 25 immunoassay channels, including five open channels for assay customization. Throughput for a two module system is as high as 2,770 tests per hour. With a total of over 140 on-board assays, the analyzer offers the ability to perform disease management on a single platform. The broad test menu includes assessment for anemia (B12, folate, ferritin, iron, RBC folate, soluble transferrin receptor, and transferrin), and assessment for cardiac risk (troponin T, hsCRP, CK-MB, myoglobin, triglycerides, direct HDL, direct LDL and total cholesterol.) According to Roche, an assay for proBNP will launch in November, pending FDA approval. Other available assays target diabetes, thyroid function, tumor markers, coagulation (D-Dimer) and fertility.
Sample routing is performed with a third-generation, three-land bidiretional track-based system controlled by a Windows NT-based operator interface. Up to 300 samples may be on-board simultaneously. This type of capacity led to enhancements in the sample handling process. “We realized that it would not be enough to simply design a single platform for both technologies,” said Davis. “We also wanted to provide results faster by making the sample handling decisions automatically for the operator. Our Enhanced Intelligent Process Management software “thinks” for the system by controlling a very complex sample routing process that maximizes the productivity of the system.” While highly automated, the analyzer allows operators to easily prioritize sample runs and define repeats and reflex testing. STAT samples can be loaded into the priority port and processed without workflow interruption.
System maintenance is also automated and can be scheduled during off-peak hours. If service is needed, operators can mask modules to perform maintenance without reverting the entire system to standby mode. For reagent handling, the system software provides a graphic display to allow operators to easily monitor levels and number of tests remaining. If the primary reagent bottle happens to run-out, the system automatically loads the secondary source without operator intervention or system downtime. The Integrated Modular Analytics system uses the same reagents as other Roche analyzers, allowing for standardization with existing systems in the laboratory or across the customer’s laboratory network.
Since its introduction, Roche has experienced high levels of interest from many different types of laboratories. “We are finding that there is a broad range of applications for this product. We’ve received orders from high-volume blood bank customers, and from hospitals looking for a mainline analyzer to run routine workloads. We’ve also had interest from laboratories that perform a high volume of specialty panels,” said Davis. The system is offered as a stand-alone product, and can be configured with a Modular Pre-Analytics for even greater sample-handling efficiency.
The availability of both clinical chemistry and immunoassay methods on one platform offers obvious advantages and helps address issues surrounding the increasing workloads found in today’s clinical laboratories. This technology integration also adds a new dimension to strategic planning and future capital equipment purchasing decisions. “For those considering the purchase of either a new clinical chemistry or immunoassay analyzer, once you’ve made the initial capital investment new assays can be added at essentially no cost, with no additional provisions required for maintenance and training,” said Davis.
Louise Lazear is a freelance writer based in Charlotte, N.C.
