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Antiphospholipid Syndrome Criteria Panel

Justification

This panel will detect laboratory abnormalities characteristic of Antiphospholipid Syndrome (APS), including the presence of a lupus anticoagulant, antibodies against the membrane phospholipid cardiolipin (IgG, IgM and IgA isotypes) and antibodies against B2GP1 (IgG, IgM and IgA isotypes). Catastrophic antiphospholipid syndrome (CAPS) is a rare, life-threatening form of APS characterized by the presence of a triple-positive APS lab work-up. Detecting a single, double, or triple positive result can significantly change patient management. Lupus anticoagulant and antiphospholipid antibodies increase the risk of arterial thrombosis, venous thrombosis, thrombocytopenia and recurrent miscarriage.

Panel Component Tests

aPTT-LA (Lupus Sensitive) Russell Viper Venom Time (dilute) Anticardiolipin Antibody (IgG, IgM, IgA) Beta-2 Glycoprotein I Antibody (IgG, IgM, IgA)

STAT: < 48 hours (M-F)

Clot-based, CIA

Draw Tube: Blue Top

Draw Tube: Red Top

Sample Type: Citrated Plasma and Serum

Specimen Requirements

Sample Type Volume Required Minimum Volume Stability
PREFERRED Citrated Plasma and Serum Three aliquots, 1mL each (Citrated Plasma);One aliquot, 1mL (Serum) Three aliquots, 0.5mL each (Citrated Plasma);One aliquot, 0.5mL (Serum) Frozen (-20C): 2 weeks
Frozen (-80C): 6 months
ALTERNATIVE - - - -
REJECTION CRITERIA Thawed in transit if shipped frozen, refrozen, clotted sample
SPECIAL INSTRUCTIONS -

General Information

METHODOLOGY Clot-based, CIA
STAT TAT < 48 hours (M-F)
STAT TAT Performance > 90% of results released in 48 hours
ROUTINE TAT < 1 week
ALTERNATIVE NAMES APS Panel, Lupus Anticoagulant (LA), Antiphospholipid Antibody testing, CAPS work-up
DESCRIPTION Antiphospholipid antibodies are present in Antiphospholipid Syndrome (APS) and may be detected in both solid (CIA) and plasmatic-based tests. Beta-2 Glycoprotein I (B2GPI) antibodies measured above 20 CU are considered positive and are associated with APS as described by international consensus and Harris et al [1,2] Persistently elevated levels of B2GPI antibodies are associated with an increased risk of vascular thrombosis and obstetrical complications [3,4]. This assay employs an FDA-approved, chemiluminescent immunoassay (CIA) method and reports in arbitrary chemiluminescent units (CU).
LIMITATIONS -
NORMAL RANGE Interpretation: Normal
ASSOCIATED TESTING -
REFERENCES

1. Ruiz-Irastorza G et al. Antiphospholipid syndrome. Lancet 2010; 376:1498.

2. Giannakopoulos B et al. How we diagnose the antiphospholipid syndrome. Blood 2009; 113:985.

3. Pengo V et al. Update of the guidelines for lupus anticoagulant detection. Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2009; 7:1737.

4. Bertolaccini ML et al. Antiphospholipid antibody tests: spreading the net. Ann Rheum Dis 2005; 64:1639.

5. Vila P et al. Prevalence, follow-up and clinical significance of the anticardiolipin antibodies in normal subjects. Thromb Haemost 1994; 72:209.
SAMPLE REPORT Upon request
NEW YORK STATE APPROVED Yes

Test Codes

ORDER CODE P1212
CPT CODE 86147x3, 86146x3, 85613, 85730
LOINC CODE 3181-5, 3182-3, 5076-5