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Cardiolipin Antibody, IgM

Ordering Recommendation

Acceptable initial test when antiphospholipid syndrome (APS) is highly suspected. Order with Lupus Anticoagulant Reflexive Panel (0030181) and Beta-2 Glycoprotein 1 Antibodies, IgG and IgM (0050321). Cardiolipin Antibodies, IgG and IgM (0099344) is preferred.

Mnemonic
AC-IGM
Performed
Mon-Sat
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay
Reported
1-2 days
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 1 mL serum to a Standard Transport Tube. (Min: 0.3 mL)
Storage/Transport Temperature:
Refrigerated.
Unacceptable Conditions:
Plasma or other body fluids. Contaminated, heat-inactivated, hemolyzed, or lipemic specimens.
Remarks:
Stability:
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year
Reference Interval
<=12 MPL
Negative
13-19 MPL
Indeterminate
20-80 MPL
 
Low to Moderately Positive
81 MPL or above
High Positive
Interpretive Data
The persistent presence of IgG and/or IgM cardiolipin (CL) antibodies in moderate or high levels (greater than 40 GPL and/or greater than 40 MPL units) is a laboratory criterion for the diagnosis of antiphospholipid syndrome (APS). Persistence is defined as moderate or high levels of IgG and/or IgM CL antibodies detected in two or more specimens drawn at least 12 weeks apart (J Throm Haemost. 2006;4:295-306). Lower positive levels of IgG and/or IgM CL antibodies (above cutoff but less than 40 GPL and/or less than 40 MPL units) may occur in patients with the clinical symptoms of APS; therefore, the actual significance of these levels is undefined. Results should not be used alone for diagnosis and must be interpreted in light of APS-specific clinical manifestations and/or other criteria phospholipid antibody tests.
Compliance Category: FDA
Note
MPL = IgM phospholipid units
CPT Code
86147
Components
Component Chart Name
Cardiolipin Antibody IgM
Component Test Code
0050902
LOINC
3182-3
Aliases
ACA
aCL
aCL Antibody
aCL IgG
Anti-Cardiolipin
Anticardiolipin
Anticardiolipin Antibodies
Cardiolip
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