Friday, August 13, 1999
New tests could speed E.coli detection
FDA approves Meridian's kits for sale
BY TIM BONFIELD
The Cincinnati Enquirer
The next time E.coli strikes the Tristate, a new test kit from Cincinnati-based Meridian Diagnostics Inc. may help speed treatment of victims and the investigation of possible causes.
The U.S. Food and Drug Administration on Tuesdaygranted Meridian Diagnostics clearance to begin marketing its ImmunoCard STAT! E.coli test kit. The kit can detect E.coli O157:H7 within 10 minutes, compared to traditional lab culture methods that can take 24 to 72 hours, said Richard Eberly, vice president of sales and marketing at Meridian. .
A fast test would be good news for public health officials who often struggle to pin down the causes of food-borne illness outbreaks.
For example, health officials investigating a recent cluster of 29 E.coli cases in Greater Cincinnati say they might have some answers today about possible causes — more than two months after the first case was reported.
“I think the test will be helpful,” said Malcolm Adcock, Cincinnati health commissioner. “The earlier you can get to an investigation, the higher the probability that you can identify the source.”
When it takes days to get results using current methods, some doctors don't bother ordering E.coli tests; they just treat patients' symptoms. But that means some cases never get reported, which can prevent public health departments from spotting clusters.
Even when tests confirm an E.coli problem, the time delay involved can hamper investigations by making it harder for victims to remember what they ate and where, and harder for investigators to collect food samples.
By the time testing and victim interviews lead officials to a common source, such as a restaurant or a certain brand of packaged food, there often is no unconsumed tainted food to be found, Dr. Adcock said.
Beyond testing human stool samples for signs of E.coli O157:H7, Meridian's test can be used to check food for contamination. In fact, a large fast-food chain has required its suppliers to use Meridian's test kit for about a year. That was possible because FDA approval was not required to use the product on food samples, but was required to test human samples, Mr. Eberly said.
With FDA's approval secured, Meridian immediately began selling and shipping test kits to hospitals, reference laboratories, licensed physician labs and public health departments.
“We had built up a supply because we were anticipating the FDA approval for the past couple of months,” Mr. Eberly said.
Locally, Meridian also has provided free test kits to hospitals for use in the current E.coli cluster investigation.
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