4067 – Anti-Faktor H

Intended Purpose

The Anti-Faktor H is a quantitative immunoassay for the determination of IgG antibodies against complement factor H (CFH) in human serum. The Anti-Faktor H is intended as an aid in the diagnosis of atypical hemolytic-uremic syndrome (aHUS) in conjunction with other clinical and laboratory findings. Furthermore, the assay provides precise measurement of CFH antibodies, which play a critical role in identifying patients with complement-mediated disorders. It supports differentiation between typical HUS, caused by Shiga toxin-producing Escherichia coli, and atypical forms linked to complement dysregulation. Clinicians can use the results to guide timely therapeutic interventions, including plasma exchange or complement inhibitor therapy, and to monitor disease progression. The test also aids in assessing patient prognosis and can contribute to family genetic counseling when hereditary complement mutations are suspected. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Hemolytic-uremic syndrome (HUS) is a microvascular disease characterized by hemolytic anemia, thrombocytopenia, and acute renal failure. Most cases are caused by Shiga toxin-producing Escherichia coli, presenting first with watery or sometimes bloody diarrhea, followed by possible extra-intestinal complications. Neurological and cardiac complications may also occur, and up to 10% of severe cases are lethal. About 5% of patients develop atypical HUS, which lacks diarrheal symptoms and results from complement regulation disorders caused by genetic mutations or autoantibodies to CFH. Detecting these antibodies is critical for accurate diagnosis, differentiation, and personalized patient management.