Test Catalog

Test Id : LKM

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Liver/Kidney Microsome Type 1 Antibodies, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluation of patients with liver disease of unknown etiology

 

Evaluation of patients with suspected autoimmune hepatitis

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Liver/Kidney Microsome Type 1 Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Antibodies to Liver\Kidney Microsome Type 1, Serum

LKM1 (liver/kidney microsome type 1) antibodies

Microsomal (Liver/Kidney) Type 1 Antibodies

aLKM 1

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-General Request (T239)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat treated Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluation of patients with liver disease of unknown etiology

 

Evaluation of patients with suspected autoimmune hepatitis

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Autoimmune hepatitis (AIH) is 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 diverse autoantibodies which also serves to subcategorize patients.(2) AIH type 1 is associated with F-actin reactive smooth muscle autoantibody (SMA), antinuclear autoantibody (ANA) (60% of patients), and autoantibody to SLA/LP (15% to 20% of patients), while AIH type 2 is associated with LKM-1 and LC-1 autoantibodies.(3) 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).(4) 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 major target for anti-LKM-1 antibodies is the cytochrome P450 2D6 (CYP2D6).(5) Following the identification of this autoantibody target, a number of solid-phase immunoassays have been developed for the evaluation of anti-LKM-1 antibodies.

 

Although not diagnostic in isolation, the presence of certain autoantibodies has been reported to be important in establishing the diagnosis of AIH. Published diagnostic criteria for AIH which include testing for autoantibodies (ANA, SMA, anti-LKM-1, and anti-SLA), determination of serum immunoglobulin, histopathology, evaluation for viral hepatitis, and other indices have been developed based on scoring systems.(6-8). These diagnostic scoring systems are useful in AIH research studies and may not substitute appropriate clinical assessment in routine patient evaluation.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

< or =20.0 Units (Negative)

20.1-24.9 Units (Equivocal)

> or =25.0 Units (Positive)

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Seropositivity for anti-liver/kidney microsomal antibodies type 1 antibodies is consistent with a diagnosis of autoimmune hepatitis type 2, in patients with compatible clinical symptoms and histopathology.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Mieli-Vergani G, Vergani D, Czaja AJ, et al. Autoimmune hepatitis. Primer. 2018;4:18017. doi:10.1038/nrdp.2018.17

2. Beretta-Piccoli BT, Mieli-Vergani G, Vergani D. Serology in autoimmune hepatitis: A clinical-practice approach. Eur J Intern Med. 2018;48:35-43. doi:10.1016/j.ejim.2017.10.006

3. Toh BH. Diagnostic autoantibodies for autoimmune liver diseases. Clin Transl Immunology. 2017;6(5):e139. doi:10.1038/cti.2017.14

4. Liberal R, Mieli-Vergani G, Vergani D. Clinical significance of autoantibodies in autoimmune hepatitis. J Autoimmun. 2013;46:17-24. doi:10.1016/j.jaut.2013.08.001

5. Manns MP, Johnson EF, Griffin KJ, Tan EM, Sullivan KF. Major antigen of liver kidney microsomal autoantibodies in idiopathic autoimmune hepatitis is cytochrome P450db1. J Clin Invest. 1989;83(3):1066-1072. doi:10.1172/JCI1139496

6. Hennes EM, Zeniya M, Czaja AJ, et. Al. Simplified criteria for the diagnosis of autoimmune hepatitis. Hepatology. 2008;48(1):169-76. doi:10.1002/hep.22322

7. Ducazu O, Degroote H, Geerts A, et al. Diagnostic and prognostic scoring systems for autoimmune hepatitis: a review. Acta Gastroenterol Belg. 2021;84(3):487-495. doi:10.51821/84.3.014.

8. Harrington C, Krishnan S, Mack CL, Cravedi P, Assis DN, Levitsky J. Noninvasive biomarkers for the diagnosis and management of autoimmune hepatitis. Hepatology. 2022;76(6):1862-1879. doi:10.1002/hep.32591

Method Description
Describes how the test is performed and provides a method-specific reference

Purified full-length recombinant human cytochrome P450 2D6 antigen is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Pre-diluted controls and diluted patient sera are added to separate wells, allowing any liver/kidney microsomal antibodies type 1 present to bind to the immobilized antigen. Unbound sample is washed away, and an enzyme labeled anti-human IgG antibody (conjugate) is added to each well. A second incubation allows the enzyme labeled anti-human IgG antibody to bind any patient antibodies, which have become attached to the microwells. After washing away any unbound enzyme labeled anti-human IgG antibody, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay is evaluated by spectrophotometrically measuring and comparing the color intensity that develops in the patient wells with the color in the calibrator wells. (Package insert: INOVA Diagnostics, Inc.; Revision 13; 10/2018)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Wednesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86376

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
LKM Liver/Kidney Microsome Type 1 Ab, S 32220-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
LKM Liver/Kidney Microsome Type 1 Ab, S 32220-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports