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Laboratory: Clinical Immunology
Test Name:
ANTI-PHOSPHOLIPID PROFILE - (S)
Test Code: APHL
Clinical Information:
Alternate Name(s):
Anti-Phospholipid Antibodies
Antiphospholipid Antibodies
Anticardiolipin Antibodies
Cardiolipin Antibodies
Anti-β2-Glycoprotein 1
Beta-2 Glycoprotein 1 Antibodies
Beta-2 GP1 Ab

Phospholipid Antibodies occur in patients with a variety of manifestations:
* Thrombotic events both arterial and venous
* Obstetric abnormalities: unexplained fetal death, premature birth, placental insufficiency,  and severe preeclampsia
* Cutaneous abnormalities: livido reticularis, pyoderma gangrenosum
* Peripheral blood cytopenia, thrombocytopenia, or hemolytic anemia
 
Diagnosis of antiphospholipid syndrome requires a positive test result of either cardiolipin,    β2-Glycoprotein or lupus anticoagulant on more than one occasion separated by at least 12 weeks, in addition to either thrombosis, fetal loss, or thrombocytopenia. Only IgG and IgM antibodies are tested as IgA antibodies lack specificity.
 
These antibodies are also known to be more frequent in patients with systemic rheumatic diseases and are also produced in response to infections and as a non-autoimmune epiphenomenon of thrombotic events.
 
Collection Devices:
Preferred Device:
1 - Serum Separator (SST) Tube(s) - Full Tube Collection
Specimen Required:
Serum: 1.0 mL

Specimen Stability:
Refrigerated: 14 Days
Frozen: 30 Days
Referral:
Serum: 1.0 mL

Shipping & Storage: Separate serum and ship refrigerated, or frozen if greater than 7 days from time of collection

Testing Laboratory: St. Boniface Hospital Immunology Laboratory
Requisition:
Reference Values:
Reference Intervals:
Anti-β2-Glycoprotein 1 (IgG and IgM):   0 - 19 RU/ml
Anti-Cardiolipin (IgG and IgM):              0 - 11 PL-IgG(M)-U/ml
A negative result does not necessarily exclude autoimmune disease.  Positive results should not be interpreted in isolation and must be correlated with relevant clinical findings.

Method of Analysis:
The ELISA test kits provide a quantitative in vitro assay for human autoantibodies of the IgG and IgM class against cardiolipin and β2-Glycoprotein 1 in serum.
Availability:
Within 1 Week
ELISA tests are batched tests
See Also:
More Information:
  Sensitivity Specificity
Anti-β2-Glycoprotein 1 IgG 43% 100%
Anti-β2-Glycoprotein 1 IgM 52% 97.5%
Anti-Cardiolipin IgG 67% 100%
Anti-Cardiolipin IgM 38% 99.8%

Reportable Range:
Anti-β2-Glycoprotein 1 (IgG and IgM):  2 - 200 RU/ml
Anti-Cardiolipin (IgG and IgM):              2 - 120 PL-IgG(M)-U/ml

References:

1.         EUROIMMUN: Anti-β2-Glycoprotein 1 ELISA (IgG) Test Instruction,  EA_1632G_A_UK_C05.doc, Version 18/03/2014
2.         EUROIMMUN: Anti-β2-Glycoprotein 1 ELISA (IgM) Test Instruction, EA_1632M_A_UK_C07.doc, Version 05/09/11
3.         EUROIMMUN: Anti-Cardiolipin ELISA (IgG) Test Instruction, EA_1621G_A_UK_C06.doc, Version 21/07/2017
4.         EUROIMMUN: Anti-Cardiolipin ELISA (IgM) Test Instruction, EA_1621M_A_UK_C06.doc, Version 15/02/2016