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Mitochondrial M2 Antibody, IgG (ELISA)

Ordering Recommendation

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

Mnemonic
AMA
Performed
Mon-Sat
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay
Reported
Within 24 hours
New York DOH Approval Status
This test is New York DOH 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 a 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)
Reference Interval
20.0 Units or less
Negative
20.1-24.9 Units
25.0 Units or greater
Equivocal
Positive
Interpretive Data
Anti-mitochondrial 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.
Compliance Category: FDA
Note
CPT Code
86381
Components
Component Chart Name
Mitochondrial (M2) Antibody, IgG
Component Test Code
0050065
LOINC
14251-3
Aliases
AMA
ANTI-MITOCHONDIRAL ANTIBODY
ANTIBODIES TO MICROTUBULE ASSOCIATED PROTEIN 2
ANTIMITOCHONDRIAL ANTIBODIES
IMMUNOLOGY PROFILE (AMA)
MITOCHONDRIAL ANTIBODIES, SERUM
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