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FDA Clears Two Techlab Campylobacter Tests

NEW YORK (360Dx) – Techlab said today that the US Food and Drug Administration has granted 510(k) clearance for two tests intended to aid in the diagnosis of campylobacteriosis, which is produced by Campylobacter, a foodborne pathogen that's among the most common causes of diarrheal illness in the US.

One test, Campylobacter Quik Chek, detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes, the firm said. Another, Campylobacter Chek, has a 96-well plate format for laboratories testing large numbers of specimens, can be used with or without automation, and produces a result in about one hour, Techlab added. 

“Most Campylobacter testing is still performed by culture because the diagnostic immunoassays on the market have a [positive predictive] value of less than 50 percent," Joel Herbein, VP of scientific affairs at Techlab, said in a statement. However, culture requires up to 72 hours before a result is possible, and it is technically challenging due to the microaerophilic growth requirements of the bacteria, he added.

According to Techlab, both of its tests have accuracies that surpass culture testing, and they have some of the highest positive predictive values among available Campylobacter immunoassays.