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Test Code Billings Clinic: 9552 Mayo: CLPMG Phospholipid (Cardiolipin) Antibodies, IgG and IgM, Serum

Reporting Name

Phospholip Ab (Cardiolip) IgM/IgG

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

The following clinical situations:

-Unexplained arterial or venous thrombosis

-A history of pregnancy morbidity defined as 1 or more unexplained deaths of a morphologically normal fetus beyond the 10th week of gestation, 1 or more premature births before 34 weeks of gestation caused by severe preeclampsia or placental insufficiency, or 3 or more unexplained, consecutive spontaneous abortions before the 10th week of gestation with no identifiable maternal hormonal or anatomic, or maternal or paternal chromosomal causes

-Presence of a systemic autoimmune rheumatic disease especially systemic lupus erythematosus

-Presence of an unexplained cutaneous manifestations varying from livedo reticularis to cutaneous necrosis such as leg ulcers

-Unexplained thrombocytopenia

-Possible nonbacterial, thrombotic endocarditis

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-treated specimen Reject

Reference Values

MPL refers to IgM phospholipid units. One MPL unit is 1 microgram of IgM antibody.

GPL refers to IgG phospholipid units. One GPL unit is 1 microgram of IgG antibody.

 

Negative: <15.0 MPL or GPL

Weakly positive: 15.0-39.9 MPL or GPL

Positive: 40.0-79.9 MPL or GPL

Strongly positive: ≥80.0 MPL or GPL

 

Reference values apply to all ages.

Interpretation

Moderate-to-strong positive results for anticardiolipin (aCL) IgG or IgM antibodies (≥40 IgG phospholipid [GPL] or IgM phospholipid [MPL] units) in association with specific clinical manifestations may be diagnostic for antiphospholipid syndrome (APS).

 

Low levels of aCL IgG or IgM antibodies, especially in the absence of other criteria phospholipid (aPL) antibodies should be interpreted with a high degree of suspicion. Compared to aCL IgG, low and isolated levels aCL IgM antibodies have a very low risk for APS and should be interpreted with a high degree of suspicion.

 

Documentation of persistent aCL IgG and IgM antibodies is a requirement for the diagnosis of definite APS. Antibodies must be detected on 2 or more occasions at least 12 weeks apart to fulfill the laboratory diagnostic criteria for APS.

 

Detection of beta-2 glycoprotein 1 antibodies using the enzyme-linked immunosorbent method or other solid-phase immunoassays is not affected by anticoagulant treatment.

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 2 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86147 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CLPMG Phospholip Ab (Cardiolip) IgM/IgG 24319-6

 

Result ID Test Result Name Result LOINC Value
GCLIP Phospholipid Ab IgG, S 3181-5
MCLIP Phospholipid Ab IgM, S 3182-3

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Coagulation Test Request (T753)

-Renal Diagnostics Test Request (T830)

Profile Information

Test ID Reporting Name Available Separately Always Performed
MCLIP Phospholipid Ab IgM, S Yes Yes
GCLIP Phospholipid Ab IgG, S Yes Yes