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 assists clinicians in diagnosing atypical hemolytic-uremic syndrome (aHUS) when used together 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 helps determine patient prognosis and supports genetic counseling when clinicians suspect hereditary complement mutations. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Hemolytic-uremic syndrome (HUS) is a rare but serious microvascular disorder characterized by the triad of hemolytic anemia, thrombocytopenia, and acute renal failure. The majority of HUS cases are caused by infections with Shiga toxin-producing Escherichia coli, typically presenting with an initial phase of watery or bloody diarrhea. These cases may progress to systemic complications, including neurological and cardiac involvement, with severe instances resulting in mortality rates of up to 10%.

Atypical HUS, which accounts for approximately 5–10% of all HUS cases, is not associated with diarrheal illness and results from dysregulation of the alternative complement pathway. This can arise due to genetic mutations affecting complement regulatory proteins or the development of autoantibodies against CFH. Such antibodies inhibit CFH function, leading to persistent complement activation, endothelial injury, and thrombotic microangiopathy. Detection of CFH antibodies is therefore essential for accurate diagnosis, differentiation from typical HUS, and the planning of targeted treatment strategies.

Timely identification of CFH antibodies informs therapeutic decisions, enabling clinicians to initiate plasma exchange or complement inhibition early and reduce the risk of organ damage, particularly to the kidneys. Quantitative measurement of CFH antibodies also supports ongoing patient monitoring, allowing assessment of treatment efficacy, disease recurrence, and long-term prognosis. These results also support research on complement-mediated disorders and help scientists develop new therapeutic approaches.