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With shrinking clinical lab budgets and rising demand for testing, smart uses of automation are essential for meeting healthcare needs, while ensuring the most accurate and reliable results. As molecular testing replaces conventional assays such as culture and other time-intensive tests, there is real opportunity to automate manual processes.
For clinical labs, automation has a number of important benefits. Reducing hands-on time allows a fixed number of technicians to run more tests and better accommodate spikes in demand. Test protocols tend to be much faster, making it possible for lab personnel to return results to physicians more quickly to have a more immediate impact on patient care. With fewer steps requiring human intervention, automated testing eliminates much of the opportunity for error along the workflow. Finally, it produces more consistent results than even the most careful technician, increasing reproducibility across the lab.
Throughout the clinical lab workflow—from running commercial platforms to developing new tests in-house—there are several aspects for which automation is helpful.
Adopting automated diagnostic platforms has allowed many clinical laboratories to streamline testing workflows, reduce errors, and free up technicians’ time for other tasks. Many of these instruments handle all steps between sample loading and reporting results; they can process the sample for testing, add reagents when necessary, and run thermal cycling programs needed for PCR. Carefully designed systems eliminate room for error as much as possible with advances such as barcoding to track samples and quality checks to avoid running the wrong test on a sample.
Some automated platforms incorporate additional processes or include other features for an increased benefit to clinical lab teams. For example, platforms that can run samples loaded at different times allow technicians to start a new sample even when a run is already underway on the same instrument. This makes it possible for labs to offer both stat and batch testing, making them more responsive to physicians’ needs in urgent situations.
Faster run times also contribute to smoother lab operations. Systems that eliminate the need for up-front sample processing not only save technician time, but turn results around much more quickly and allow labs to generate more same-day answers for optimal patient care. Shaving even a few hours off a workflow makes it possible for clinical lab teams to produce same-day results for tests received later in the day—physicians who order tests after 5 pm no longer have to wait until the next day to make important decisions about the use of antibiotics or other treatments for certain cases.
Assay design
An extremely effective use of automation in clinical labs is with systems capable of running both in vitro diagnostics and laboratory-developed tests. This way, lab teams get the full benefit of automation regardless of whether they’re using a commercial or in-house assay. Also, flexibility in testing makes it possible to rely on a single instrument for assays designed to detect a number of different diseases or pathogens.
Using such a platform makes it simpler for labs to develop new assays. Some automated systems feature a consistent thermal cycling profile for all tests, allowing labs to build their own assays without having to adjust settings that can be challenging to get right. This allows skilled lab staff to focus on accurately detecting the analyte of interest without getting too bogged down in the underlying technical details of the test platform.
While clinical labs have many options for automated testing platforms, automating the software and IT side of things has been more taxing. There are several related problems: most instruments run proprietary software and can only be controlled from built-in screens; some laboratory information systems are not able to connect directly to many of the platforms; and manual data entry is a widely accepted limitation in clinical labs, so scientists do not actively push for ways to avoid it.
A truly automated approach would allow lab information systems to connect to all test platforms and control everything from order entry to reporting results. Currently, too many lab teams must take an order manually from the information system, find the relevant sample, and run it with the correct assay. Even low-volume labs would see more accurate results with an automated information flow; at high-volume labs, the manual process is simply untenable.
Automating the data side would also allow lab teams to view results from each machine at a central command station, rather than on an instrument screen that requires the user to write results down and manually enter them into the information system later. This is especially helpful for integrated delivery networks, allowing lab members in a central location to analyze data from a satellite lab. Syncing these systems can save time and dramatically reduce the chance that results are misrepresented in a lab’s final report by automatically populating the data directly from the test instrument.
Clinical lab teams will be more efficient with automated data solutions that reduce manual data entry, centralize data for reporting and trending, and accelerate the process of getting from a test order to test results. An added benefit is that this type of approach would make it easier to train new technicians, facilitating the validation and calibration studies needed for ongoing lab accreditation.
What’s next
As demand for molecular testing soars, clinical laboratory teams are faced with the challenge of having to generate more results even in the face of shrinking budgets. Automating testing technology, assay design protocols, and data flow will make it possible for labs to successfully address this challenge. Saving even a small amount of time for a particular process can have a significant cumulative impact. The time savings from even a single automated process adds up in the long run, while the benefit of automating many processes can streamline operations and give technicians a few hours of extra time each day to develop new assays, evaluate new platforms, and carry out other important responsibilities that can help contribute to improved patient outcomes.
Adrian Russell is product manager, IVD Systems, at Luminex Corp., 12212 Technology Blvd., Ste. 130, Austin, TX 78727, U.S.A.; tel.: 512-219-8020, e-mail: [email protected]; www.luminexcorp.com