Test Code #

059

CPT Code(s) #

86147 x3, 86146 x3

Test Name

Antiphospholipid syndrome Panel (Cardiolipin IgG, IgA, IgM & B2 GP1 IgG, IgA, IgM)

If Profile, Includes Tests:

N/A

Disease Name:

Antiphospholipid Syndrome

Type of Study:

Serum Studies

Methodology:

Fluoroenzyme immunoassay (FEIA)

Substrate:

N/A

Reference Range:

Cardiolipin IgG (GPL-U/mL)
• Negative <10
• Weak Positive 10-40
• Positive >40

Cardiolipin IgA (APL-U/mL)
• Negative <14
• Equivocal 14-20
• Positive >20

Cardiolipin IgM (MPL-U/mL)
• Negative <10
• Weak Positive 10-40
• Positive >40

Beta 2 Glycoprotein I IgG (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

Beta 2 Glycoprotein I IgA (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

Beta 2 Glycoprotein I IgM (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

Units:

APL U/mL; MPL U/mL; GPL U/mL (Units/mL)

Schedule:

Assay performed once every week. Report availability is within one week from the time of specimen receipt

Specimen Requirements:

Collect 5-10 ml of blood in a red top or serum separator tube. If possible, separate serum from clot and place into red capped tube provided with Beutner Laboratories collection kits. If separation facilities are not available, the blood can be sent in the tube used for collection.

Sample Stability:

Sample is stable at ambient temperature during shipment. If sample is stored prior to shipment, it is stable refrigerated (2-8ºC) up to five days and frozen (-20ºC or lower) up to one year

Clinical Relevance:

Antiphospholipid syndrome (APS) is a heterogeneous autoimmune disorder characterized by arterial or venous thromboembolic events and/or pregnancy morbidity in the setting of persistently positive antiphospholipid antibodies (aPL). APS is classified according to the Sapporo criteria. It is defined as the presence of at least one of the clinical criteria and one of the laboratory criteria included in the classification. The three major antiphosphosholipid antibody tests recognized by the international classification criteria for APS are anticardiolipin antibodies (IgG, IgM), anti-beta 2 glycoprotein antibodies (IgG, IgM) and the lupus anticoagulant (LA). The antiphopholipid antibodies must be present in medium or high titers on two or more occasions at least 12 weeks apart. The Systemic Lupus International Collaborating Units (SLICC) classification includes IgA isotypes of these antibodies as part of the definition of antiphospholipid activity. Positive findings for cardiolipin (IgA) and ß2 GP1 (IgA) antibodies fulfill the preliminary laboratory criteria for the diagnosis of Antiphospholipid Syndrome (APS). The diagnosis of APS should not be based solely on these laboratory findings of positive antiphospholipid antibodies (aPL). Suggestive clinical findings must be present. Follow up, repeat tests for these antibodies after 12 weeks is indicated (please see comment). Low titer aPL and lupus anticoagulant can be found in 1%-5% young, healthy adults with a higher prevalence in pediatric populations.

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