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FDA clears rapid Campylobacter tests
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Techlab Inc. announced today that FDA has cleared for marketing its two rapid Campylobacter tests that can give results within an hour.
The Campylobacter Quik Chek and Campylobacter Chek are designed to help diagnose a type of diarrhea known as campylobacteriosis.
The Campylobacter Quik Chek detects Campylobacter jejuni and C. coli in less than 30 minutes, according to a Techlab news release. Campylobacter Chek — a 96-well plate format designed to test large numbers of specimens — detects pathogens in about an hour.
Techlab says the tests are more accurate than culture and have the highest positive predictive values (PPV) of Campylobacter immunoassays currently available.
“Most Campylobacter testing is still performed by culture because the diagnostic immunoassays on the market have a PPV of less than 50%,” Joel Herbein, vice president of scientific affairs at Techlab, said in the news release. “But culture requires up to 72 hours to give a result and is technically challenging due to the microaerophilic growth requirements of the bacteria. The Campylobacter products we have developed have a high PPV, can be performed on the benchtop in 30 minutes for the rapid [test] to about an hour for the 96-well plate format, and offer clinicians more confidence in their testing results.”
Herbein told Infectious Disease News that, in a clinical evaluation, the Campylobacter Quik Chek detected all 34 positive human fecal specimens that were also correctly identified by culture. The Quik Chek also detected 13 additional positive specimens that culture failed to detect, he said. Those 13 specimens were confirmed positive using a molecular composite reference method.
“This indicates that the true prevalence of Campylobacter is likely higher than is currently recognized from culture alone,” he said.
Herbein said his company’s tests can also identify the Campylobacter species C. lari and C. upsaliensis, both of which are poorly detected by culture. He added that antibiotics can worsen diarrheal disease caused by certain pathogens, making it important for clinicians to correctly identify the pathogen.
“The ability of our tests to accurately identify all these Campylobacter species is important in that doctors can make an informed decision on the safety or necessity of antibiotic treatment of patients,” Herbein said. “This allows more patients with Campylobacter infections to be diagnosed and treated correctly.” – by Joe Green
Disclosure: Herbein is employed by Techlab.