Cardiolipin Antibody, IgM

0050902
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Example Reports
Negative
Positive

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

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

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 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

Reference Interval

Effective November 15, 2021

<=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

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/15/2022
X
11/15/2021
X
N/A

CPT Codes

86147

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Components

Component Test Code* Component Chart Name LOINC
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 Antibody
  • aCL IgM
  • Anti-Cardiolipin
  • Anticardiolipin
  • Anticardiolipin Antibodies
  • Cardiolip
Cardiolipin Antibody, IgM