Like Thomas Edison said, genius is one percent inspiration and 99 percent perspiration. The same is true of science.
But every once in a while, even amidst the relentless work, a scientific advance is sparked by the twin catalysts of creativity and chance. It happened to Dr. Richard Decker in 1972, when a simple string of pearls inspired him to pursue an idea. An idea that would reduce the risk of hepatitis B contamination at blood banks and change the entire blueprint of many diagnostic tests.
The story begins one year earlier, in 1971. The hepatitis B virus was a fast-growing threat to global public health. Often caused by tainted blood transfusions and the use of unsterilized needles, the hepatitis B infection takes hold in the liver where the virus rapidly replicates before spreading to the bloodstream. If untreated, hepatitis B can cause irreversible liver damage and even death. The spread of the disease was especially troubling for blood banks across the world, which were acutely aware of the dangers it posed to transfusion recipients. But the most widely used hepatitis blood-screening test at the time was a simple agar gel diffusion that, while easy to perform, lacked accuracy. There was a worldwide need for a better solution.
Dr. George Dawson, an Abbott virologist who was mentored by Richard Decker, recounts the tale of how Richard, biochemist Ghung-Mei Ling and virologist Lacy Overby worked together to find that solution. “At that time, the mortality rate for transfusion-related hepatitis was close to one percent,” says George. “So the three of them said, ‘Let’s do something, let’s make a test.’”
And they did. In 1972, the doctors created a breakthrough product: a meticulously engineered, highly sensitive and highly accurate test kit they called AUSRIA-125.
“They submitted it to the FDA, it got [approved] and they had it. The most sensitive test out there [at the time],” says George. In fact, the test was roughly 10,000 times more sensitive than the agar gel method. The next step was to send the kit to medical practices across the United States. It was instantly successful.
Almost too successful. In just three short months they had sold out of the product planned to last an entire year. Meanwhile, blood banks from faraway corners of the world were beginning to request it.
“Great news for management, but not for manufacturing,” remembers Richard, now retired.
It seemed impossible to make enough AUSRIA to keep up with demand. Doctors and blood banks wouldn’t be able to get the test kits they needed. Patients wouldn’t be able to get tested. And it was all because of one slow, laborious and unfortunately very necessary step in the process—the coating of thousands of plastic tubes with antibodies. Frustrated, they continued to search for an answer.
One night during a dinner party, Richard was describing the roadblock to the other diners. It was the shape of the tubes that was the problem, he explained. Because they were hollow, they had to be filled with the coating. And filling them took time. Thoughtfully, a guest detached the pearls around her neck and held them up to the light. “What about coating these?” she ventured.
Eureka. Why not? Richard, knowing that sometimes the best solution is the one that literally breaks the mold, was instantly intrigued. He mused that an externally coated object would be much easier to prepare. “All you would have to do is put the pearl in a solution.” It seemed almost too simple to work. But he brought the idea to his Abbott colleagues and they, too, were excited about the possibilities.
One quick call to a Chicago manufacturer later, and they developed beads to experiment with the new concept. After submerging the beads in the antibody solution, they ran them through the AUSRIA system.
“And it worked great,” says Richard with a grin.
Actually, the results were remarkable. The improved system allowed them to coat as many as 100,000 beads at one time in the space of one afternoon. Now they would be able to dramatically increase production for shipment worldwide.
Thus began the mass production of AUSRIA II. In addition to speedier production turnaround, the new kit also featured faster test results and a significant increase in sensitivity. That meant Abbott was able to ship it to blood banks in huge numbers. Within a year, more than 70 percent of the blood donated for transfusions in the United States was being tested with the AUSRIA II kit, and it was being adopted in Europe and Asia.
More than four decades later, Richard believes that the impact of their innovation has echoed across generations. Though the components of the test have changed with the times—the beads have been replaced by much tinier microparticles, the system has evolved in efficiency and sensitivity—the influence behind the original blueprint for AUSRIA II can still be seen in today’s hepatitis B diagnostic tests. But even greater than the impact of the innovation itself is the impact it has had on human lives, from transfusion recipients to people diagnosed with hepatitis B who would be able to seek treatment more quickly.
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