Meridian Bioscience have announced that it has been granted FDA clearance to market an additional claim related to its ImmunoCard STAT!(R) E. coli O157 Plus. This test identifies the most dangerous Shiga toxin-producing E. coli bacteria that can cause severe kidney damage or death, especially in infected children under 5 years of age. This new claim will enable the toxin- producing E. coli O157 antigens to be detected from the most commonly used collection and transport culture medium, thereby reducing time and labor for the testing laboratory.

The first recognized U.S. outbreak of E. coli O157 was reported in 1982 and was associated with eating hamburgers from a particular fast-food chain. Since 1982, E. coli O157 outbreaks have occurred more frequently with approximately 13% of these due to food sources other than beef products. It is now estimated that, among children under 5 years of age, the incidence of infection can be as high as 6 per 100,000.