NEW YORK – On the back of its 510(k) clearance from the US Food and Drug Administration earlier this month, Danaher subsidiary Beckman Coulter Diagnostics has launched its DxC 500 I analyzer in the US to target low- and medium-throughput laboratories.
The instrument combines clinical chemistry and immunoassay capabilities in one automated analyzer and utilizes the same chemistry and immunoassay reagents as Beckman's mid- and high-volume analyzers, said Kathleen Orland, senior VP and general manager of Beckman's Clinical Chemistry Immunoassay business unit.
The firm's goal with the new instrument is to bring automation into the low-throughput space, with a particular focus on integrated health networks that usually have multiple smaller laboratories throughout the health system.
"We've really had a strategy of automation for all" across the firm's instrument portfolio, she said.
Using the same reagents for all immunoassay and clinical chemistry instruments "provides inventory and cost control" for the health system and ensures patient test results are commutable across the network at each site, an important capability for patient management because if a patient has a test performed at an outpatient clinic or smaller hospital within the health system and then is admitted to a different hospital or setting and has the same test performed again, those results can be easily compared because the reference ranges are the same, she said.
This "helps the physician in really analyzing those results and looking for changes," Orland said. "The physician can make a more informed decision about what's going on with that patient or their care."
The system itself includes a sample handler in the middle for a common point of entry that allows both sides of the analyzer to be run independently if necessary. If one side of the machine is undergoing calibration or maintenance, the other side can still process samples and provide results, Orland said. The sample handler also manages repeats and reruns without technologist intervention.
The independent operating modes help the laboratorians in terms of workflow, as the technician isn't limited by calibration or maintenance times, and the instrument can be used for clinical chemistry and immunoassays together or separately, she added.
But the combination of both clinical chemistry and immunoassay is useful because a laboratorian does not have to split a sample — sample processing is automated for both the clinical chemistry and immunoassay portions of the instrument.
"It takes a lot out of the hands of the technologist in terms of manual sample management," she added. "Anything that we can do to improve workflow in the laboratory, bring more automation, ease the use of the technologist and what they need to do on a daily basis is certainly helpful."
The platform has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour and includes Beckman Coulter’s FlexMode, which prioritizes testing according to each sample's urgency.
The instrument also includes "load-on-the-fly reagents," which allow new reagents to be reloaded while the system is running, rather than having to shut off the entire instrument to reload.
The clinical chemistry side of the instrument has also been upgraded and was originally launched last year as the standalone DxC 500 AU platform. One of the new features was the ability to do hemoglobin A1c testing with whole blood, a capability the new DxC 500 I also includes.
The immunoassay side of the instrument comprises technology from the firm's Access 2 Immunoassay System.
The DxC 500 I instrument has a "whole new user interface" compared to the firm's previous chemistry and immunoassay analyzers, Orland said. It is the same interface as the one on the company's high-volume DxI 9000 instrument that was launched in 2023.
While Beckman Coulter has focused on the use of the instrument in smaller community laboratories or outpatient care settings within a larger health network, Orland noted that the DxC 500 I could also be used in a large central laboratory as a backup for a mainline analyzer.
"It can offer redundancy for a large laboratory and then be a primary instrument in a satellite laboratory or in a smaller community hospital," she added.
The DxC 500 I was launched in Europe last year, and Orland said there has been "a lot of interest" in the platform outside of the US. "We're really happy with the commercialization and how that's been going outside the United States, so we're really excited to bring it here into the US."
Beckman Coulter will be joining the fray among other big name diagnostic companies that also have combined clinical chemistry and immunoassay analyzers, including Roche Diagnostics and Abbott. Roche offers its Cobas Pure Integrated Solutions system, which combines its Cobas E 402 immunoassay unit and Cobas C 303 clinical chemistry unit with its Sample Supply Unit. That platform can run up to 120 immunoassays and 750 clinical chemistry tests per hour and is also intended for use in integrated health networks.
Abbott's Alinity CI-Series system, meantime, combines the firm's Alinity C clinical chemistry instrument and the Alinity I immunoassay instrument and can perform up to 1,550 tests per hour.
Nathan Ledeboer, the medical director of clinical microbiology at the Medical College of Wisconsin, said via email that multianalyte analyzers like the DxC 500 I "increase the capabilities of the local laboratory while minimizing the space that is occupied by instrumentation." In his view, multianalyte instrumentation is the "wave of the future" for both clinical laboratories and point-of-care testing.
Multianalyte analyzers "can allow a local laboratory that may have offered a limited test menu the ability to significantly expand testing that is performed locally instead of shipping it to a central lab," as well as empowering "physician office laboratories to provide the same quality of results that are available from a central lab."
Ledeboer added that as long as the DxC 500 I works well in clinical laboratories and can manage diverse specimen types, he does not see a great deal of downside for the instrument. Ledeboer's high-volume reference laboratory has separate instrumentation, but he said he could see an instrument like the DxC 500 I fitting in his area's community hospitals.