Ordering Recommendation

Acceptable initial test when antiphospholipid syndrome (APS) is strongly suspected. Order with Lupus Anticoagulant Reflex Panel (3017009) and Beta-2 Glycoprotein 1 Antibodies, IgG and IgM (0050321).

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 1 mL serum to an ARUP 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 (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-2 days

Reference Interval

Test Number
Components
Reference Interval
  Cardiolipin Antibody IgG 14 GPL or less
  Cardiolipin Antibody IgM 12 MPL or less

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.


Component Interpretation
Cardiolipin Antibody, IgG <=14 GPL
15-19 GPL
20-80 GPL
81 GPL or above
Negative
Indeterminate
Low to Moderately Positive
High Positive
Cardiolipin Antibody, IgM <=12 MPL
13-19 MPL
20-80 MPL
81 MPL or above
Negative
Indeterminate
Low to Moderately Positive
High Positive

Compliance Category

FDA

Note

GPL = IgG phospholipid units; MPL = IgM phospholipid units

Hotline History

N/A

CPT Codes

86147 x2

Components

Component Test Code* Component Chart Name LOINC
0050901 Cardiolipin Antibody IgG 3181-5
0050902 Cardiolipin Antibody IgM 3182-3
* 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

  • ACA
  • aCL
  • aCL Ab
  • aCL antibodies
  • aCL IgG, IgM
  • Anti-Cardiolipin
  • Anti-Phospholipid Antibodies
  • Anticardiolipin
  • Anticardiolipin Antibodies
  • Cardiolip
  • Cardiolipin Antibodies, IgG and IgM, Serum
Cardiolipin Antibodies, IgG and IgM