Ordering Recommendation

Acceptable initial test when antiphospholipid syndrome (APS) is strongly suspected. Order with Lupus Anticoagulant Reflex Panel (3017009) 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).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (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)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-2 days

Reference Interval

Test Number
Components
Reference Interval
  B2Glycoprotein 1, IgG Antibody <=20 SGU
  B2Glycoprotein 1, IgM Antibody <=20 SMU

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

Hotline History

N/A

CPT Codes

86146 x2

Components

Component Test Code* Component Chart Name LOINC
0050322 B2Glycoprotein 1, IgG Antibody 44448-9
0050323 B2Glycoprotein 1, IgM Antibody 44449-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

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-2 Glycoprotein 1
Beta-2 Glycoprotein 1 Antibodies, IgG and IgM