Ordering Recommendation

Not a recommended panel for the diagnosis of antiphospholipid syndrome (APS). The Cardiolipin Antibodies, IgG and IgM (0099344) is preferred.

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

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
  Cardiolipin Antibody IgA 11 APL 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                        Negative
15-19 GPL                       Indeterminate
20-80 GPL                       Low to Moderately Positive
81 GPL or above            High Positive
Cardiolipin Antibody, IgM <=12 MPL                     Negative
13-19 MPL                    Indeterminate
20-80 MPL                    Low to Moderately Positive
81 MPL or above        High Positive
Cardiolipin Antibody, IgA <=11 APL                   Negative
12-19 APL                  Indeterminate
20-80 APL                  Low to Moderately Positive
81 APL or above      High Positive

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86147 x3

Components

Component Test Code* Component Chart Name LOINC
0050901 Cardiolipin Antibody IgG 3181-5
0050902 Cardiolipin Antibody IgM 3182-3
0098358 Cardiolipin Antibody IgA 5076-5
* 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 Antibodies
  • aCL Antibody
  • Anticardiolipin Antibodies
  • Cardiolip
  • Cardiolipin Antibodies, IgA, IgG, IgM
Cardiolipin Antibodies, IgG, IgM, and IgA