Beta-2 Glycoprotein 1 Antibodies, IgG and IgM

Ordering Recommendation

Acceptable initial test when antiphospholipid syndrome (APS) is strongly suspected. Order with Lupus Anticoagulant Reflexive Panel (0030181) and Cardiolipin Antibodies, IgG and IgM (0099344). May also be useful in estimating risk of thrombosis and/or pregnancy-related morbidity in patients with systemic lupus erythematosus (SLE).

Mnemonic

B2GPI PAN

Performed

Mon-Sat

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-2 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation:

Collect:

Serum separator tube.

Specimen Preparation:

Separate serum from cells ASAP or within 2 hours of collection. (Min: 0.3 mL)

Storage/Transport Temperature:

Refrigerated.

Unacceptable Conditions:

Plasma or other body fluids. Contaminated, hemolyzed, grossly icteric, or severely lipemic specimens.

Remarks:

Stability:

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Reference Interval

Components

<=20 SGU

B2Glycoprotein 1, IgG Antibody

<=20 SMU

B2Glycoprotein 1, IgM Antibody

Interpretive Data

The persistent presence of IgG and/or IgM beta 2 glycoprotein I (B2GPI) antibodies is a laboratory criterion for the diagnosis of antiphospholipid syndrome (APS). Persistence is defined as moderate or high levels of IgG and/or IgM B2GPI antibodies detected in two or more specimens drawn at least 12 weeks apart (J Throm Haemost. 2006;4:295-306). B2GPI results greater than 20 SGU (IgG) and/or SMU (IgM) are considered positive based on the cutoff values established for this test. International reference materials and consensus units for anti-B2GPI antibodies have not been established (Clin Chim Acta. 2012;413(1-2):358-60; Arthritis Rheum. 2012;64(1):1-10.); results can be variable between different commercial immunoassays and cannot be compared. Strong clinical correlation is recommended for a diagnosis of APS. Low positive IgG and IgM B2GPI antibody levels should be interpreted in light of APS-specific clinical manifestations and/or other criteria phospholipid antibody tests.

Compliance Category: FDA

Note

MPL = IgM phospholipid units

CPT Code

86146 x2

Components

Component Chart Name

B2Glycoprotein 1, IgG Antibody

Component Test Code

0050322

LOINC

44448-9

0050323

B2Glycoprotein 1, IgM Antibody

44449-7

Aliases

Anti-B2-Glycoprotein 1

Anti-B2-Glycoprotein I

Anti-B2-GP 1

Anti-B2-GP1

Anti-B2-GPI

Anti-beta-2 glycoprotein 1

Anti-beta-2 glycoprotein I

Apolipoprotein H

Apolipoprotein H, APOH

B2 Glycoprotein 1 antibodies

B2GP Antibodies

B2GP1

B2GPI IgG, IgM

BECKY

Beta 2 GP1 Ab IgG

Beta 2 GP1 Ab IgM

Beta 2GP1 Ab

Beta 2Glycoprotein 1