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

Reporting Name

Beta 2 GP1 Ab, IgM/IgG, S

Useful For

Evaluation of patients with suspected antiphospholipid syndrome by identification of beta-2 glycoprotein 1 (beta-2 GP1) IgG and IgM antibodies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


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

<15.0 U/mL (negative)

15.0-39.9 U/mL (weakly positive)

40.0-79.9 U/mL (positive)

≥80.0 U/mL (strongly positive)

Results are expressed in arbitrary units and apply to IgG and IgM values.

Reference values apply to all ages.

Day(s) and Time(s) Performed

Monday through Saturday; 8 a.m.

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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 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

Clinical Reference

1. Caronti B, Calderaro C, Alessandri C, et al: Beta2-glycoprotein 1 (beta2-GP1) mRNA is expressed by several cell types involved in anti-phospholipid syndrome-related tissue damage. Clin Exp Immunol 1999;115:214-219

2. Lozier J, Takahashi N, Putnam F: Complete amino acid sequence of human plasma beta-2-glycoprotein 1. Proc Natl Acad Sci USA 1984;81:3640-3644

3. Kra-Oz Z, Lorber M, Shoenfeld Y, Scharff Y: Inhibitor(s) of natural anti-cardiolipin autoantibodies. Clin Exp Immunol 1993;93:265-268

4. Wilson WW, Gharavi AE, Koike T, et al: International consensus statement on preliminary classification criteria for definite antiphospholipid syndrome. Arthritis Rheum 1999;42(7):1309-1311

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

Method Description

Purified beta-2 GPI antigen is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Prediluted controls and diluted patient sera are added to separate wells, allowing any beta-2 GPI IgM or IgG antibodies present to bind to the immobilized antigen. Unbound sample is washed away and an enzyme-labeled antihuman IgM conjugate is added to each well. A second incubation allows the enzyme-labeled antihuman IgM or IgG to bind to any patient antibodies that have become attached to the microwells. After washing away any unbound enzyme-labeled antihuman IgM or IgG, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay can be evaluated spectrophotometrically by measuring and comparing the color intensity that develops in the patient wells with that of a 5-point calibration curve. Results are reported out semiquantitatively in standard IgM anti-beta-2 GPI units (SMU) and standard IgG anti-beta-2 GPI units (SGU).(Package Inserts: QUANTA Lite beta 2 GP1 IgM ELISA, Inova Diagnostics, February 2015 Revision 13 and QUANTA Lite 2[2] GP1 IgG ELISA, Inova Diagnostics, March 2016 Revision 18)

Analytic Time

Same day/1 day

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Forms

If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.

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

Secondary ID

62926