Developed by the Robert Koch Institute to be applied to HUS-cases associated with the 2011 Germany outbreak.
HUS Clinical criteria: A clinical picture of acute enteropathogenic HUS is defined by the presence of at least two of the following three criteria:
1. Hemolytic anemia
2. Thrombocytopenia ≤ 150,000 cells/mm3,
3. Renal dysfunction.
Laboratory confirmed cases: Positive result in at least one of the following tests:
Detection of Shigatoxin
Culture of the pathogen and isolation only from stool AND detection of Shigatoxin Stx2 using ELISA on the E. coli culture,
Mixed culture of the pathogen, enriched stool cultures or isolation of E. coli AND nucleic acid amplification test (e.g. PCR) for detection of the shigatoxin gene stx2 from the same sample
Indirect (serological) detection
Detection of ant-LPS-IgM-antibodies against E.coli Serogroups (once markedly increased titre/concentration, e.g., using ELISA, Western Blot)
Marked change between two consecutive samples in titreconcentrarion of anti-LPS-IgG-antibodies against E.coli serogroups e.g.; using ELISA)
Suspect HUS case: Case with a clinical picture of acute enteropahogenic HUS as assessed by the attending physician, but not formally meeting the clinical criteria (at least two of three) identified above, are classified as suspect cases regardless of laboratory confirmation.