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Abbott's Alinity Immunoassays Enabling Commercial Lab to Handle Rising Test Volumes

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NEW YORK (360Dx) – Regional Medical Laboratory, a commercial reference lab, has begun using the Abbott Alinity i immunoassay system in a core laboratory located in Tulsa, Oklahoma, and is seeing benefits related to the system's scalable design.

RML began using the immunoassay system in its core laboratory last October and has plans to continue expanding the overall adoption of Abbott's suite of next-generation diagnostic testing systems, Brittany Vaughn, director of clinical operations at RML's core laboratory, said in an interview, adding the scalable design of the Alinity makes it easier for RML to add additional instruments and testing as laboratory testing volumes continue to rise.

Rising test volumes, shortages of trained laboratory staff, and lab consolidation is driving greater levels of automation both in her laboratory and on broader scale in many other labs, she noted.

The Alinity ci-series of instruments for clinical chemistry and immunoassays have been on the market for a few years after receiving CE marking in January 2017, allowing the technology to be marketed in Europe and other countries accepting the designation. In October of that year, the US Food and Drug Administration granted 510(k) clearance for the systems.  

The Alinity c clinical chemistry system and Alinity i immunoassay system can be used individually or as an integrated Alinity ci-series unit. The ci-series instruments have half the footprint of some existing systems due to its stacked design, Abbott has said.

Abbott CEO Miles White said during a conference call in January to discuss the company's Q4 and 2018 financial performance that in 2018 the firm accelerated the launch of Alinity instruments and tests in Europe and other international markets, and Abbott anticipates obtaining US regulatory approvals for a critical mass of its test menu over the coming months, which would allow it to accelerate the launch of Alinity in the US later this year.

White noted that so far, everything has been on track with the rollout in Europe including its expectations for market share capture and customer conversions to the technology.

Abbott declined to disclose revenues or placements specific to the Alinity,  but generally, sales of advanced, integrated clinical chemistry and immunoassay systems are being driven in part by a trend toward more centralized testing in response to economic and operational pressures, according to diagnostic industry executives.

Growth in clinical chemistry and immunoassay systems is reflected in the financial results of some of the diagnostic companies offering such systems. In 2018, Roche booked CHF 7.77 billion (US 7.72 billion) in revenues for its centralized and point-of-care solutions business. The main drivers of business growth were immunodiagnostics sales, with a year-over-year increase of 11 percent, and clinical chemistry sales, which grew year-over-year increase at 7 percent.

In its fiscal first quarter 2019 results announced recently, Siemens Healthineers said that it shipped more than 370 of its new Atellica clinical chemistry and immunoassay analyzers in the quarter. By the end of 2020, Siemens is targeting shipment of more than 7,000 analyzers.

Eliminating manual procedures

In the case of the Alinity systems, their installation at RML is eliminating many manual procedures and freeing up time for the laboratory staff to focus on activities that support patient care, Vaughn said.

RML, which is part of the Ascension health network, provides testing services for physicians and hospitals and it expects to use Alinity to conduct testing for millions of patients. Overall, the lab performs diagnostic tests for more than 2.4 million patients throughout hospital systems in Texas, Wisconsin, Oklahoma, Kansas, and Tennessee, and it offers anatomic and clinical pathology services through a partnership with Pathology Laboratory Associates.

Established in 1983, RML completes about 9 million clinical and anatomical tests involving 170,000 surgical specimens per year. Testing volume has grown about 3 to 5 percent each year, a trend that is anticipated to continue, Vaughn said.

It operates a large core laboratory that performs specialized, high-volume testing, and it operates labs affiliated with hospitals that conduct rapid response testing.

"Our strategy has been to take up a support role with hospitals in our region, functioning as their reference lab and allowing them to focus and grow based on what they do well while we take on [testing] that we do well," Vaughn said.

"We can only expect greater testing volume and we are continuing to experience greater difficulty in finding trained staff, and so we have to continue to look at automation as a solution," she said. "We were looking at how we could take on this growth without adding people and concluded that we had to automate our processes."

Before deciding to begin implementing the Alinity immunoassay module, RML conducted an analysis of several undisclosed vendors. In the end, a team of healthcare managers throughout the Ascension health network found that Alinity could meet current and future needs, not just within RML but also within the broader Ascension system, Vaughn said.

"We decided as a team, not just here locally but nationally, that Alinity was a great fit for many of our sites," as many of the sites are experiencing the same drivers to adopt automation as her lab, she said.

Over the past several years, RML has brought in more than 100 new tests and that has enabled it to grow test volumes, and that process is expected to continue, she said.

About a year before implementing the technology, RML began planning for it, a process that included designing the space before installing and connecting machines and making sure that procedures had been updated and staff trained.

Within the first six months of its implementation, the Alinity immunoassay system and tests, which use chemiluminescent detection technology, have enabled RML to "dramatically reduce" the hands-on time spent on many of the blood specimens received in the lab, Vaughn said.

Laboratorians now load blood specimens directly to the Alinity track, and RML's specimen processing team, which previously handled thousands of tubes — one at a time, each day — have been reassigned to other tasks. And for testing completed by Alinity, the laboratory's medical technologists no longer have to do centrifugation, and uncap and recap tubes prior to storing them in a refrigerator.

The trained experts who previously did this manual work have been reassigned to other lab activities benefiting patient care, Vaughn said, adding, "We see it as a win-win for the lab and the patients."

Evaluating test results and helping interpret them for physicians are among the higher value tasks completed by laboratorians.

RML has also seen a reduction in staff overtime and higher staff satisfaction levels.

RML, however, has not quantified the amount of time or costs saved as a result of installing the Alinity, and RML is continuing to refine workflows and find additional ways to improve overall processes, Vaughn said.

Thus far, RML has implemented the Alinity for immunoassay testing, but it has not yet implemented the companion clinical chemistry module. That is primarily because of the timing of contract renewals for its clinical chemistry test systems, Vaughn said, adding the laboratory "expects to grow the size and scope of tests performed by the Alinity over time."

With Alinity, RML benefits from standardization and a user friendly approach to operating instruments and reviewing data, she said.

"Abbott designed the Alinity to be error-proof and we're seeing direct implications on quality and reliability of the results that we're releasing," Vaughn said, adding that the Alinity assays are free of the risk of biotin interference, an issue that laboratorians increasingly have to be aware of, she said.

When RML implemented Alinity, its core lab attached one third-party instrument to its track — the DiaSorin Liaison, an immunoassay analyzer that allows running up to 15 different assays at a time with a small number of samples, according to DiaSorin. Having the ability to put non-Abbott testing on its track, further automating the lab, leads to greater flexibility and capability, Vaughn said.

"In the future, I'd like to see is us continue working with our vendor partners to collaborate for greater connectivity among disciplines within the laboratory, and to be able to automate additional testing," she said. Connectivity to third-party systems requires compatible hardware and software, however, and whether vendors are even interested in facilitating connection to other firms' instruments "is a key question," Vaughn said.

Connecting with third-party systems and tests is "less about Alinity and more about the total solution that involves bringing in other partners in meeting a laboratory's needs," Vahe Ayvazian, director of the US marketing team for Abbott's core laboratory business, said in an interview.

"Abbott looks at the challenges a lab is trying to solve and if automation is an important part of that, we can look to find other companies to work with," he said. In this way, Abbott can help further drive its customers' lab efficiencies and enable them to provide better patient care, he said.

However, getting vendors who are competitors to cooperate with one another can slow progress. "It's something you have to build over time with some of the other manufacturers, and it's not as simple as flipping a switch," Ayvazian said.