Ordering Recommendation

Recommended initial screening panel when autoimmune liver disease is strongly suspected. If negative, less frequently occurring autoantibody tests maybe ordered based on patient’s clinical presentation and history.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 1.5 mL serum to an ARUP Standard Transport Tube. (Min: 1.0 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Non-serum, heat-inactivated, contaminated, grossly icteric, severely lipemic, grossly hemolyzed specimens or inclusion of fibrin clot.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody

Performed

Sun-Sat

Reported

1-8 days

Reference Interval

Test Number
Components
Reference Interval
  Mitochondrial (M2) Antibody, IgG 24.9 Units or less
  Soluble Liver Antigen Antibody, IgG 24.9 U or less
  Liver-Kid Microsome-1 Ab, IgG by ELISA 24.9 U or less
  F-Actin (Smooth Muscle) Ab, IgG by ELISA 19 Units or less
  Antinuclear Antibody (ANA), HEp-2, IgG Less than 1:80

Interpretive Data




Component Interpretation
Mitochondrial M2 Antibody, IgG (ELISA) 20.0 Units or less  Negative
20.1-24.9 Units   Equivocal
25.0 Units or greater  Positive
Soluble Liver Antigen Antibody, IgG 0.0-20.0 U  Negative
20.1-24.9 U  Equivocal
Greater than or equal to 25.0 U  Positive
Liver-Kidney Microsome - 1 Antibody, IgG 0.0-20.0 U  Negative
20.1-24.9 U  Equivocal
25.0 U or greater  Positive
F-Actin (Smooth Muscle) Ab, IgG by ELISA 19 Units or less   Negative
20 - 30 Units  Weak Positive-Suggest repeat testing in two to three weeks with fresh specimen.
31 Units or greater   Positive-Suggestive of autoimmune hepatitis type 1 or chronic active hepatitis.

Compliance Category

FDA

Note

If F-Actin, IgG by ELISA is 20 Units or greater, then Smooth Muscle Antibody (SMA), IgG by IFA titer will be added. Additional charges apply.
ANA identified by indirect fluorescence assay (IFA) using HEp-2 substrate and IgG-specific conjugate at a screening dilution of 1:80. Positive nuclear patterns reported include homogeneous, speckled, centromere, nucleolar, or nuclear dots. Positive cytoplasmic patterns reported include reticular/AMA, discrete/GW body-like, polar/golgi-like, rods and rings, or cytoplasmic speckled patterns. All positive results are reported with endpoint titers at no additional charge.

Hotline History

N/A

CPT Codes

86381; 83516; 86376; 86015; 86039; if reflexed, add 86256

Components

Component Test Code* Component Chart Name LOINC
0050065 Mitochondrial (M2) Antibody, IgG 14251-3
0055235 Soluble Liver Antigen Antibody, IgG 38420-6
0055241 Liver-Kid Microsome-1 Ab, IgG by ELISA 47318-1
0055248 F-Actin (Smooth Muscle) Ab, IgG by ELISA 44706-0
3000090 Antinuclear Antibody (ANA), HEp-2, IgG 21424-7
3000096 ANA Interpretive Comment 49311-4
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

Autoimmune Liver Disease Reflexive Panel