4053 – Anti-LKM-1

The Anti-LKM-1 is a quantitative immunoassay 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.

Patients suffering from autoimmune hepatitis (AIH), one of the primary autoimmune liver disease, including primary biliary cirrhosis and primary sclerosing cholangitis, show a variety of autoantibodies. These autoantibodies may be grouped into two; type I characterized by the occurrence of antinuclear antibodies (ANA) and antibodies to smooth muscles (ASMA), and type II, a high prevalence of antibodies to liver and kidney microsomal antigens (LKM).

LKM antibodies are specific for type II hepatitis, as they recognize epitopes of cytochrome P450 IID6, a 50kDa cytoplasmic protein found in hepatocytes and proximal tubular kidney cells. In addition to the role in AIH, LKM-1 associated AIH is an important parameter in paediatrics as it predominantly occurs in girls between 2 and 14 years of age.

The ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient´s sample, they bind to the antigens. A secondary antibody conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product. The signal intensity of the reaction product is proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.

The immunoassay is designed for manual professional in vitro diagnostic use.