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Test Name:
Cardiolipin IgM Antibody
- SBMF No:
28103 - Performance Lab Name:
Immunology - Test Mnemonic:
CARDM - ABN:
Not required - CPT Code:
86147 - LOINC Code:
8067-1 - Also Known As:
ACL IgM Antibody
Anticardiolipin IgM
Phospholipid IgM Antibody - Also See:
28104 Cardiolipin IgA Antibody
28102 Cardiolipin IgG Antibody - Spec Type:
Serum - Spec Container:
Gold top (SST) or red top (serum) tube - Pref Vol:
0.5 mL - Min Vol:
0.3 mL - Fasting:
No - Spec Collect:
Routine venipuncture - Spec Process:
Clot 30 minutes
Promptly centrifuge 15 minutes
Immediately transfer serum to separate plastic tube
Properly centrifuged gel barrier tube sample does not require transfer of serum to separate tube - Spec Store Transport:
Refrigerated (48 hours) or frozen - Spec Stability:
8 hours room temperature (20-30°C)
48 hours refrigerated (2-8°C)
1 month, frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles - Spec Reject:
Severely hemolyzed or lipemic sample - Methodology:
Enzyme-Linked Immunosorbent Assay (ELISA) - Use:
To detect the presence of anti-cardiolipin antibodies (ACL) that have been shown to be associated with recurrent vascular thrombosis, recurrent spontaneous abortions, and thrombocytopenia—a combination that has been termed “Antiphospholipid Antibody Syndrome” - Clinical Significance:
Autoantibodies directed against certain phospholipids, including anti-cardiolipin antibodies (ACL), have been shown to be associated with recurrent vascular thrombosis, recurrent spontaneous abortions, and thrombocytopenia. This combination has been termed “Antiphospholipid Antibody Syndrome.”ACL antibodies are similar to other antiphospholipid antibodies called lupus anticoagulants (LA) because they can be seen in as many as 30% of patients with systemic lupus erythematosus. Despite its name and the associated prolongation of the PTT, there is a paradoxical increased association with recurrent thrombosis. ACL antibodies are also seen in patients with other autoimmune or connective tissue diseases, those undergoing chlorpromazine treatment, as well as patients with no known underlying diseases.Patients may demonstrate autoantibodies to either lupus anticoagulants or cardiolipin or both. The anticoagulant activity can be evaluated by the “Circulating Anticoagulant Detection Test.”The cardiolipin antibody test results are as either normal or low, moderate, and high positive for both IgG and IgM antibodies. Some authors have suggested that the criteria for diagnosis of “Antiphospholipid Antibody Syndrome” include both an abnormal clinical event (vascular thrombosis, immune thrombocytopenia, or recurrent abortion) as well as an abnormal laboratory test indicative of LA or a moderate or high titer of IgG ACL antibodies. Although there are individual patient exceptions, clinical symptoms are less common with ACL than with LA, particularly when the antiphospholipid syndromes are associated with infection or medication, are of low titer, and are of IgM isotype - Reference Range:
Normal: less than 20
Low Positive: 20 to less than 30
Moderate: 30 to less than 80
High Positive: equal to or greater than 80 - Additional Test Info:
Results in the Low Positive range are of questionable significance and must be carefully interpreted with regard to the clinical picture.
Positive results for IgM only may be due to non-specific binding and should likewise be carefully interpreted.
Most patients with “Antiphospholipid Antibody Syndrome” have moderate or high levels of cardiolipin antibodies and are positive for IgG only or IgG & IgM. Transiently positive tests do occur; thus, it is recommended that positive results be confirmed by follow-up assay in 8 weeks. - Day Run:
Tue, Fri - Time Run:
8:00 am - Time Reported:
5:00 pm, next day - Test Type:
IMMUNOLOGY
