Ordering Recommendation

May be useful in confirming a diagnosis of primary biliary cholangitis.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL to an ARUP standard transport tube. (Min: 0.3 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma. Contaminated, hemolyzed, grossly icteric, or severely lipemic specimens.

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 (ELISA)

Performed

Sun-Sat

Reported

1-2 days

Reference Interval

Test Number
Components
Reference Interval
  Mitochondrial (M2) Antibody, IgG 24.9 Units or less

Interpretive Data

Antimitochondrial antibodies (AMA) are thought to be present in 90-95% of patients with primary biliary cholangitis (PBC). However, the frequency of detected antibodies may be cohort or assay dependent, as lower sensitivities have been reported. Not all PBC patients are positive for AMA; some patients may be positive for SP100 and/or GP210 antibodies. A negative result does not rule out PBC.


Component
Interpretation
Mitochondrial M2 Antibody, IgG (ELISA) 20.0 Units or less              Negative
20.1-24.9                          Equivocal
25.0 Units or greater         Positive

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86381

Components

Component Test Code* Component Chart Name LOINC
0050065 Mitochondrial (M2) Antibody, IgG 14251-3
* 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

  • AMA
  • Anti-Mitochondrial Antibody
  • Antibodies to Microtubule Associated Protein 2
  • Antimitochondrial Antibodies
  • Immunology Profile (AMA)
  • Mitochondrial Antibodies, Serum
Mitochondrial M2 Antibody, IgG (ELISA)