Technology in today’s modern laboratories has made it possible to load a rack of samples—or multiple racks of samples—onto an immunodiagnostic instrument and walk away. The past two decades have witnessed innovations enabling instruments in current use to make the hectic world of the modern laboratory easier. The instrument can aliquot the correct amount of sample for the ordered tests, know which tests require a single-step versus multi-step assays, apply the proper analyte-specific diluent to each test, know before starting whether sufficient supplies are on board for the scheduled run, flag out-of-limit results, automatically re-run flagged samples, and efficiently organize testing to achieve maximum throughput.
The science behind these technological marvels has taken years to come to fruition. And with each new breakthrough comes new opportunities to push further, to automate more, and to apply new scientific and technological advancements that further improve patient care and optimize the work of clinical laboratory professionals.
Science, engineering, and technology
Automating the variety that exists in assay processing steps across a menu of dozens of immunoassays, and optimizing the scheduling of these different automated steps against thousands of samples, requires both solid science and rigorous engineering. Designing the mapping and programming of each step across dozens of individual tests is followed by extensive validation to ensure the system will perform the testing steps accurately.
Today’s analytical systems can process dozens of samples at once with unique diluent and ratio requirements—without requiring laboratory personnel to sort and organize. Modern immunoassay analyzers can take dozens of samples and process three different formats of immunoassay with varied diluent ratios on Sample A and multiple different tests, some of which may be the same as, or different than, sample A, on Sample B and so on. Barcode technology and scientifically engineered programs allow the system to simply scan each tube and initiate the precise and proper testing from an entire menu of assays, applying proper diluents, scheduling and flags, which frees up clinical laboratory scientists to perform other necessary work in the laboratory.
The melding of science, engineering, and technology for immunoassay analyzers was revolutionary in the 1990s, when this technology was first made available. But companies immediately got to work in the mid-90s to increase the throughput capabilities of the instrumentation. LEAN principles are a way of life in the laboratory environment, and looking for opportunities to do things ever better or more efficiently is a never-ending pursuit. Thus, while many laboratories continued (and still continue) to effectively serve customers with desktop analyzers offering throughput of up to 100 tests per hour, others were quick to offer new, innovative ideas for scientists, engineers, and technicians to incorporate into the next-generation analyzers:
- Can you make it so that I don’t have to wait for a run to finish or pause the instrument before I can add supplies?
- Can you make it so that I can continuously load samples and get the tubes on to the next testing area without having to keep them on board the instrument until the run completes?
- Can you add auto-disposal of the reagent packs, so that I don’t have to manually remove them when they are finished?
- Can you have the instrument monitor sample quality to give an idea whether it may be influencing the result?
- Can you make it so that the instrument can check itself and give me an indication if some critical process is compromised? Or, even better, pause and let me know before using up precious sample material?
- Can you help me keep my laboratory compliant with environmental regulations (i.e., minimize hazardous waste production as I use the system)?
- Can you make it so I can auto-program the instrument to reflex to an additional test(s) in response to a screening test value without my having to locate and load the tube on to the system again?
Industry engineers and scientists got to work. They partnered with systems integration groups to make sure that each new feature added to the evolving instruments worked the way it was intended and without any compromise to the chemistries involved.
Today, the higher throughput analyzers use the same science and assay menu as the legacy systems, which is an advantage for users who may have a hub-and-spoke laboratory network or have both larger and smaller volume needs in specific locations. These systems also highlight what advanced engineering and technology can do for enhanced productivity in the laboratory:
- Consolidation; workflow simplification; the ability to do more with less.
- Throughput of up to 400 tests per hour.
- Sample wheel technology that aspirates the correct amount of sample onto a refrigerated sample wheel and releases the tube for storage or further testing—tubes are no longer “held hostage” in one instrument but released within five minutes.
- Refrigeration of samples on the sample wheel for up to three hours. Coupled with science and engineering that allows the instrument to scan the bar code and know what reflex tests are necessary should a test be out-of-limit, the same sample aspiration is used to run, for example, a freeT4 re-test on an abnormal TSH. (Reflex test parameters are determined by the laboratory during installation so that the system is automated to laboratory standards.)
- Supplies redundancy, including two wash buffers, so that the system automatically switches over to the second wash buffer when the first is empty and signals the laboratory team that the first needs to be refilled—without pausing testing.
- Automatic disposal of reagent packs.
Science, technology, and engineering are continuously advancing. Scientists, researchers, engineers, technicians, and service engineers continually share new information and data so that diagnostics companies can continue to advance their systems. System integration groups are purposefully designed to watch where every tube encounters every single point on the automation lines—across customer bases—and identify opportunities for further streamlining or improvement. How long does it take to run each step? Based on customer data, can centrifuge load delay be changed from 90 (or 120) seconds to 60 seconds to maximize throughput? What other efficiencies can be designed for the laboratory?
Listening to customers and sharing best practices across laboratories improves patient care. LEAN principles and continuous evaluation ignite creativity and bring tomorrow’s innovations to life. With future advances in science, technology, and engineering certain, there is little doubt that tomorrow’s laboratory systems will bring about even greater efficiencies, productivity, and quality.
