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HelpTest Code MCLIP Phospholipid (Cardiolipin) Antibodies, IgM, Serum
Additional Codes
| Mayo Test ID |
|---|
| MCLIP |
Reporting Name
Phospholipid Ab IgM, SUseful For
The following clinical situations, when used in conjunction with other criterial antiphospholipid antibody tests:
-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
-Unexplained thrombocytopenia
-Presence of an unexplained cutaneous manifestations varying from livedo reticularis to cutaneous necrosis, such as leg ulcers
-Possible nonbacterial, thrombotic endocarditis
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen Required
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.
Negative: <15.0 MPL)
Weakly positive: 15.0-39.9 MPL
Positive: 40.0-79.9 MPL
Strongly positive:≥80.0 MPL
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
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MCLIP | Phospholipid Ab IgM, S | 3182-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| MCLIP | Phospholipid Ab IgM, S | 3182-3 |
Interpretation
Moderate-to-strong positive results for anticardiolipin (aCL) IgM antibodies (≥40 IgM phospholipid [MPL] units) are a diagnostic criterion for antiphospholipid syndrome (APS). Compared to aCL IgG, isolated and low 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 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 anticardiolipin antibodies using the enzyme-linked immunosorbent assay 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):439-44
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):553-65
5. Devreese KMJ. Solid phase assays for antiphospholipid antibodies. Semin Thromb Hemost. 2022 Sep;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):1693-6
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):3885-91.
9. Cousins L, Pericleous C, Khamashta M, et al. Antibodies to domain I of ß-2-glycoprotein I and IgA antiphospholipid antibodies in patients with ‘seronegative’ antiphospholipid syndrome. Ann Rheum Dis. 2015;74(01):317-9
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):627-34
Report Available
1 to 3 daysMethod Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Day(s) Performed
Monday through Saturday