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Test Code MB2GP Beta-2 Glycoprotein 1 Antibodies, IgM, Serum

Reporting Name

Beta 2 GP1 Ab IgM, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Evaluating patients with suspected antiphospholipid syndrome by identification of beta-2 glycoprotein 1 IgM antibodies

 

First-line test when antiphospholipid syndrome is strongly suspected in conjunction with cardiolipin antibodies (IgG and IgM) and lupus anticoagulant testing

 

Estimating the risk of thrombosis and/or pregnancy-related morbidity in patients with systemic lupus erythematosus

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Additional Testing Requirements


Diagnostic criteria for antiphospholipid syndrome include the presence of at least one of the following: lupus anticoagulant, anticardiolipin, and anti-beta-2 glycoprotein 1 IgG or IgM antibodies. Consider ordering CLPMG / Phospholipid (Cardiolipin) Antibodies, IgG and IgM, Serum; GB2GP / Beta-2 Glycoprotein 1 Antibodies, IgG, Serum; and ALUPP / Lupus Anticoagulant Profile, Plasma concurrently with this test.



Specimen 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 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 specimens Reject

Reference Values

<15.0 SMU (negative)

15.0-39.9 SMU (weakly positive)

40.0-79.9 SMU (positive)

≥80.0 SMU (strongly positive)

Results are reported in standard IgM anti-beta 2 glycoprotein 1 units (SMU).

 

Reference values apply to all ages.

Interpretation

Positive results for beta-2 glycoprotein 1 (B2GPI) IgM antibodies in association with specific clinical manifestations may be diagnostic for antiphospholipid syndrome (APS).

 

Compared to IgG antibodies B2GPI, the presence of isolated and low levels of B2GPI IgM antibodies have been reported to demonstrate a low risk for APS.

 

Documentation of persistent anti- B2GPI 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 B2GPI antibodies using the enzyme-linked immunosorbent assay method or other solid-phase immunoassays is not affected by anticoagulant treatment.

Day(s) Performed

Monday through Saturday

Report Available

2 to 6 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

86146

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MB2GP Beta 2 GP1 Ab IgM, S 44449-7

 

Result ID Test Result Name Result LOINC Value
MB2GP Beta 2 GP1 Ab IgM, S 44449-7