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HelpTest Code CLPMG Phospholipid (Cardiolipin) Antibodies, IgG and IgM, Serum
Additional Codes
| Mayo Test ID |
|---|
| CLPMG |
Reporting Name
Phospholip Ab (Cardiolip) IgM/IgGUseful 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
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| MCLIP | Phospholipid Ab IgM, S | Yes | Yes |
| GCLIP | Phospholipid Ab IgG, S | Yes | Yes |
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen 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 Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days |
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.
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 |
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.
Clinical Reference
1. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306
2. Pengo V, Bison E, Denas G, Jose SP, Zoppellaro G, Banzato A. Laboratory diagnostics of antiphospholipid syndrome. Semin Thromb Hemost. 2018;44(5):439-444
3. Barbhaiya M, Zuily S, Naden R, et al. The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria. Arthritis Rheumatol. 2023;75(10):1687-1702
4. Tebo AE. Laboratory evaluation of antiphospholipid syndrome: An update on autoantibody testing. Clin Lab Med. 2019;39(4):553-565
5. Devreese KMJ. Solid phase assays for antiphospholipid antibodies. Semin Thromb Hemost. 2022;48(6):661-671. doi:10.1055/s-0042-1744364
6. Ruffatti A, Olivieri S, Tonello M, et al. Influence of different IgG anticardiolipin antibody cut-off values on antiphospholipid syndrome classification. J Thromb Haemost. 2008;6(10):1693-1696
7. Lakos G, Favaloro EJ, Harris EN, et al. International consensus guidelines on anticardiolipin and anti-beta 2-glycoprotein I testing: report from the 13th International Congress on antiphospholipid antibodies. Arthritis Rheum. 2012;64(1):1-10
8. Matsuura E, Igarashi Y, Fujimoto M, et al. Heterogeneity of anticardiolipin antibodies defined by the anticardiolipin cofactor. J Immunol. 1992;148(12):3885-3891
9. Cousins L, Pericleous C, Khamashta M, et al. Antibodies to domain I of beta-2-glycoprotein I and IgA antiphospholipid antibodies in patients with ‘seronegative’ antiphospholipid syndrome. Ann Rheum Dis. 2015;74(01):317-319
10. Nakamura H, Oku K, Amengual O, et al: First-line, non-criterial antiphospholipid antibody testing for the diagnosis of antiphospholipid syndrome in clinical practice: A combination of anti-beta2 -glycoprotein I domain I and anti-phosphatidylserine/prothrombin complex antibodies tests. Arthritis Care Res (Hoboken). 2018;70(4):627-634
Report Available
Same day/1 to 2 daysMethod Name
Enzyme-Linked Immunosorbent Assay (ELISA)
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)
Day(s) Performed
Monday through Saturday