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Test ID LKM Liver/Kidney Microsome Type 1 Antibodies, Serum


Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Secondary ID

80387

Useful For

Evaluation of patients with liver disease of unknown etiology

 

Evaluation of patients with suspected autoimmune hepatitis

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Liver/Kidney Microsome Type 1 Ab, S

Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Clinical Information

Autoimmune hepatitis (AIH) is a form of chronic liver disease that results from a loss of immune system tolerance and recognition of self-antigens.(1) AIH occurs in children and adults, with a significant female predominance. The clinical presentation of AIH varies significantly from asymptomatic liver dysfunction to acute liver failure. Evidence of liver dysfunction manifests as elevated aspartate aminotransferase, alanine aminotransferase, and gamma glutaryl transferase in the context of normal alkaline phosphatase. In addition, most individuals with AIH display increased concentrations of total IgG.

 

AIH is associated with the production of autoantibodies, which also serves to subcategorize patients.(2) AIH type I is characterized by the presence of antinuclear antibodies (ANA) and smooth muscle antibodies (SMA). AIH type I is associated with anti-liver/kidney microsomal-1 (LKM-1) and anti-liver cytosol-1 antibodies. AIH type I occurs in children and adults and usually has a relatively mild course that is responsive to steroids and azathioprine. In contrast, AIH type 2 occurs predominantly in children, with a more moderate/severe disease course.

 

Most of the autoantibodies associated with AIH were originally detected and characterized by indirect immunofluorescence (IIF).(3) Anti-LKM-1 antibodies can be detected by IIF using rodent stomach/liver/kidney composite tissue; anti-LKM-1 antibodies display staining of the proximal tubules in the kidney and cytoplasmic staining of the hepatocytes, with no reactivity on the stomach tissue. The antigen for anti-LKM-1 antibodies has been identified as cytochrome P450 2D6, which has led to the development of solid-phase and bead-based immunoassays.

 

Although not diagnostic in isolation, the various autoantibodies play an important part in establishing the diagnosis of AIH. Simplified diagnostic criteria for AIH include autoantibodies (ANA, SMA, anti-LKM-1, and anti-SLA), IgG concentrations, histopathology, and evaluation for viral hepatitis, with a scoring system to define probable or definite AIH.(4)

Reference Values

≤20.0 Units (negative)

20.1-24.9 Units (equivocal)

≥25.0 Units (positive)

Reference values apply to all ages.

Cautions

Serologic tests for autoantibodies, including anti-liver/kidney microsomal antibodies type 1 (anti-LKM-1), should not be relied upon exclusively to determine the etiology or prognosis of patients with liver disease.

 

Anti-LKM-1 antibodies are not the only serological marker for autoimmune hepatitis (AIH) and should be evaluated in the context of other AIH-associated autoantibodies, including antinuclear antibodies and smooth muscle antibodies.

 

Anti-LKM-1 antibodies may occur in some patients with chronic hepatitis caused by hepatitis C virus (HCV) infection. Although the epitopes recognized by anti-LKM-1 antibodies in HCV infection are different than in patients with AIH type 2, physicians must use caution in interpreting the results of tests for anti-LKM-1 antibodies in such patients.

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86376

NY State Approved

Yes