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Test Code B2GMG Beta-2 Glycoprotein 1 Antibodies, IgG and IgM, Serum

Useful For

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

Profile Information

Test ID Reporting Name Available Separately Always Performed
GB2GP Beta 2 GP1 Ab IgG, S Yes Yes
MB2GP Beta 2 GP1 Ab IgM, S Yes Yes

Reporting Name

Beta 2 GP1 Ab, IgM/IgG, S

Specimen Type

Serum


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 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 Minimum Volume

0.4 mL

Specimen Stability Information

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

Reference Values

BETA 2 GLYCOPROTEIN 1 (GP1) ANTIBODIES IgG:

<15.0 SGU (negative)

15.0-39.9 SGU (weakly positive)

40.0-79.9 SGU (positive)

≥ 80.0 SGU (strongly positive)

Results are reported in standard IgG anti-beta 2 GP1 units (SGU).

 

Reference values apply to all ages.

 

BETA 2 GLYCOPROTEIN 1 ANTIBODIES IgM:

<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 GP1 units (SMU).

 

Reference values apply to all ages.

Interpretation

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

 

Low levels of B2GPIIgG or IgM antibodies, especially in the absence of other criterial phospholipid antibodies should be interpreted with a high degree of suspicion. Compared to B2GPI IgG, low and isolated levels of B2GP1 IgM antibodies have been reported to demonstrate a low risk for APS.

 

Documentation of persistent anti-B2GPI 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 immunoassay 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. Lozier J, Takahashi N, Putnam F W: Complete amino acid sequence of human plasma beta 2 glycoprotein 1. Proc Natl Acad Sci U S A. 1984;81(12):3640-3644

5. Audrain MAP, El-Kouri D, Hamidou MA, el al. Value of autoantibodies to beta(2)-glycoprotein 1 in the diagnosis of antiphospholipid syndrome. Rheumatology (Oxford). 2002;41(5):550-553

6. 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

7. Devreese KMJ. Solid phase assays for antiphospholipid antibodies. Semin Thromb Hemost. 2022;48(6):661-671

8. Tebo AE. Laboratory evaluation of antiphospholipid syndrome: An update on autoantibody testing. Clin Lab Med. 2019;39(4):553-565

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

Day(s) Performed

Monday through Saturday

Report Available

2 to 6 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86146 x 2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
B2GMG Beta 2 GP1 Ab, IgM/IgG, S 72488-0

 

Result ID Test Result Name Result LOINC Value
GB2GP Beta 2 GP1 Ab IgG, S 44448-9
MB2GP Beta 2 GP1 Ab IgM, S 44449-7

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Forms

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

-General Request (T239)

-Coagulation Test Request (T753)

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.