Diagnostics & Imaging Week Executive Editor

Abbott (Abbott Park, Illinois) introduced at this week’s American Association of Blood Banks (AABB; Bethesda, Maryland) conference in Seattle the company’s newly FDA-approved Prism system, which it said is the “first fully automated blood-screening instrument.”

The new system, which received FDA approval last Friday, just prior to the opening of the AABB annual meeting, provides a considerably faster answer to the key question facing all of those involved with the collection of blood: the safety of the supplies drawn from blood donors.

That in turn helps answer an even larger question: How to increase the available supply of blood in a world with both growing needs and shrinking numbers of donors.

Greg Sunset, national director of U.S. blood and plasma centers for Abbott’s Diagnostic business, said the timing of the FDA approval “couldn’t have been better.” He told Diagnostics & Imaging Week during a Monday afternoon call from AABB that company representatives were “smiling from ear to ear and getting pats on the back from our customers,” who are eager to put the Prism system to work. “There have been a lot of big smiles around our booth,” he said. “This product has been very much anticipated.”

Sunset added: “Many blood center CEOs have said to us for some time that ‘you have to get us Prism, because we need to expand our capacity.’”

He said that 10 systems already have been installed in anticipation of the approval, including two at the nearby Puget Sound Blood Center (Seattle). Three others were shipped on Monday.

Sunset said the new automated screening system could add “a very high volume of testing capacity” for blood centers. “One Prism system does what it takes six people to do manually in a typical center,” he said. “That single system can handle about a half-million units a year.”

Describing both the existing situation and the change the Prism system might bring about, he said, “[Blood] safety is very good today, but the dilemma the blood-collection business faces is, ‘How can we make blood more available?’”

He said that only 5% of the U.S. population donates blood, and after ruling out contributions from donors because of either real or false-positive indications after that blood is tested, “we end up discarding hundreds of units of blood every day.”

Sunset said that blood banks across the U.S. have been “eager” to bring the Prism system into their labs due to its ability to handle a high number of tests with very little manual intervention and to reduce the false-positives that may unnecessarily defer a donor or worse, allow an infected unit of blood to be made available for transfusion.

Before a blood donation enters the nation’s blood supply, it is tested for evidence of exposure to viruses that may cause diseases. That screening process is resource-intensive, involving numerous assays, multiple test instruments and many manual steps.

Abbott’s Prism instrument consolidates much of that testing into a single system, minimizing the potential for manual errors and allowing more rapid testing and verification. The system features a built-in quality control system that monitors critical functions and verifies proper processing of each sample.

Dr. Jim Stewart, program director for global Prism operations at Abbott, told D&IW the system impacts three key areas in the blood collection continuum.

“First, it fills the critical need for automation of blood testing in centers,” he said. “Right now, the testing process takes 60% to 80% of the people resources in a typical blood center. With Prism, a center can redirect those resources elsewhere.”

That’s especially important, Stewart said, given wht he termed “the intense competition for laboratory personnel in the U.S.”

Secondly, said Stewart, the Prism system’s controls and sensors “automate every part of the blood-testing effort.” Needed to fulfill a variety of needs from both quality and regulatory standpoints, the system “reduces overall steps by two-thirds.”

Not the least of the system’s impacts is that the risk of an operator tampering with a test is eliminated. “Unfortunately, that [tampering] is a reality in the world we live in,” he said, “but with the Prism, once a test is started, any opportunity for operator intervention is eliminated.”

Third, and certainly not last, Stewart said the speed and accuracy of the Prism system may allow blood centers to improve upon the dismal statistic that shows only 5% of the populace as blood donors.

“It is critical that we retain these supplies,” he said, “and with Prism, we can both maintain them and potentially help reclaim those donors who have previously been eliminated through what may actually have been false-positives in the manual testing process.”

Sunset chimed in on that topic as well, noting that when large donors are permanently deferred from making donations, “that’s a real blow to the blood collection industry.”

Whether Prism can make a difference in that equation, however, awaits FDA review and approval of the “re-entry” algorithm.

The first assay to be approved for use with the Prism system is for hepatitis B, with the next two in the pipeline including one for a different hepatitis B antigen and another for the hepatitis C virus. Following those are assays related to HPLV and HIV as Abbott moves forward with a staggered-approval approach.

The Prism system already is in operation in more than 30 countries worldwide, nearly half of which use it to screen 100% of their blood donations.

Graham Sher, MD, the CEO of Canadian Blood Services, a non-profit organization that manages the blood supply at 42 sites in Canadian provinces and territories outside of Quebec, said, “Prior to acquiring the Prism system, infectious disease testing was a very labor-intensive process involving numerous steps and requiring more time to test blood before it could enter the blood supply.”

He added: “The Prism technology has not only allowed us to enhance the safety of the blood supply by eliminating this manual intervention, but also our organization is able to easily process the sudden increase in collections that are occasionally required during emergencies.”