Meridian Bioscience said its diagnostic tests detect the deadly toxins produced by the recent outbreak strain E coli O104:H4.
E coli O104:H4 is a shiga toxin-producing strain (STEC), which produces either shiga toxin 1 or shiga toxin 2, that cause complications in the infected person and also cause hemolytic uremic syndrome (HUS) (a type of kidney failure).
The US Food and Drug Administration cleared Meridian’s Premier EHEC and ImmunoCard STAT! EHEC assays detect both toxin types.
ImmunoCard STAT!EHEC provides an additional advantage in that the test differentiates between shiga toxin 1 and shiga toxin 2.
Meridian has conducted a test on clinical isolates from one of the clinical samples of infected patients utilizing its two tests for STEC and confirmed that its tests have correctly identified the samples as shiga toxin-producing and, more specifically, that it produces shiga toxin-2.
Meridian concluded that identification of the toxin 2 type enables physicians to immediately isolate and treat infected patients to reduce the likelihood for the development of HUS.
Meridian CCO Richard Eberly said they will continue to support demands by ensuring these kits in all regions where they are needed to detect and control infection.