4053 – Anti-LKM-1

Highlights

• Use of recombinant human cytochrome P450 IID6 as coating antigen
• Supports the diagnosis of autoimmune hepatitis (AIH)
• Differentiates Type II AIH from other autoimmune liver disease subtypes
• LKM-1 antibodies recognize epitopes on cytochrome P450 IID6, a 50 kDa cytoplasmic protein in hepatocytes and kidney proximal tubular cells
• Includes calibrators, positive and negative controls for assay validation
• ELISA-based assay with microtiter strips coated with recombinant human cytochrome P450 IID6
• Manual professional in vitro diagnostic use
• CE marked

Intended Use

The Anti-LKM-1 is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against cytochrome p450 IID6 in human serum. The Anti-LKM-1 is intended as an aid in the diagnosis of autoimmune hepatitis (AIH) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune hepatitis is a chronic inflammatory liver disease in which the immune system attacks hepatocytes. Clinicians classify the disease into subtypes based on autoantibody profiles. Type I AIH features antinuclear antibodies and antibodies to smooth muscle, while type II AIH shows antibodies against liver and kidney microsomal antigens, specifically LKM-1. LKM-1 antibodies target cytochrome P450 IID6, a 50 kDa cytoplasmic protein expressed in hepatocytes and proximal tubular kidney cells. These antibodies are highly specific for type II AIH and serve as critical biomarkers for diagnosis, particularly in pediatric patients, as LKM-1 associated AIH predominantly occurs in girls between 2 and 14 years of age.

Detection of LKM-1 antibodies enables early diagnosis, facilitates disease monitoring, and may help predict disease severity and progression. Type II AIH often presents with rapid disease progression and may be associated with higher rates of hepatic inflammation and fibrosis compared to type I. Testing for LKM-1 antibodies complements other clinical assessments, including liver enzyme analysis, histopathology, and imaging studies, to provide a comprehensive evaluation of disease status.