4053 – Anti-LKM-1

Intended Purpose

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

Diagnostic Relevance

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.

Product Specifications

Title Anti-LKM-1
Product code 4053
Indication Autoimmune hepatitis
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against cytochrome p450 IID6 in human serum
Format Microtiter plate coated with recombinant human cytochrome P450 IID6
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.