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Antiphospholipid Antibody Panel

Test Codes

Antrim #32032, EPIC: LAB5750, SOFT: APHSP

Department

Special Chemistry

Instructions

This panel includes:

• Anti Cardiolipin Antibodies
• Anti Beta 2 Glycoprotein I Antibodies (IgG, IgM)

Specimen Collection Criteria

Collect: One Gold-top SST tube. (Minimum Whole Blood: 2.0 mL)

Physician Office/Draw Specimen Preparation

Preparation for Courier Transport

Transport: Centrifuged collection tube, refrigerated (2-8°C or 36-46°F). (Minimum Serum: 0.5 mL)

Rejection Criteria

Plasma specimens.

Severely hemolyzed, lipemic or icteric specimens.   

In-Lab Processing

Let specimen clot 30-60 minutes then immediately centrifuge to separate serum from cells. Room temperature is acceptable for a maximum of two hours. (Minimum Serum: 0.5 mL)

Storage

Specimen Stability for Testing:

Centrifuged SST Tubes and Microtainers^® with Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Red-top Tubes and Microtainers^® without Separator Gel
Room Temperature (20-25°C or 68-77°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 72 hours
Frozen (-20°C/-4°F or below): Unacceptable

Serum Specimens (Pour-Overs)
Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 14 days
Frozen (-20°C/-4°F or below): 3 months

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Special Testing Laboratory

Performed

Monday, Wednesday, Friday.
Results available within 2 business days.

Reference Range

	Cardiolipin IgA (APL Units)	Cardiolipin IgG (GPL Units)	Cardiolipin IgM (MPL Units)
Negative	Less than 12	Less than 15	Less than 12.5
Indeterminate	12-20	15-20	12.5-20
Low-Medium Positive	Greater than 20-80	Greater than 20-80	Greater than 20-80
High Positive	Greater than 80	Greater than 80	Greater than 80

	Beta-2 Glycoprotein I IgG (SGU)	Beta-2 Glycoprotein I IgM (SMU)
Negative	Less than or equal to 20	Less than or equal to 20
Positive	Greater than 20	Greater than 20

Test Methodology

Enzyme Linked Immunosorbent Assay (ELISA).

Interpretation

See specific analytes for interpretation.
This panel includes: Anti Cardiolipin Antibodies and Anti Beta 2 Glycoprotein I Antibodies (IgG, IgM).

Clinical Utility

According to the most recent international consensus statement (see reference), the Antiphospholipid syndrome (APS) is present if at least one clinical criterion and one laboratory criterion are present.

Clinical criteria include:

1. Vascular thrombosis (arterial, venous, small vessel).
2. Pregnancy morbidities with fetal loss.

Laboratory criteria: these must occur on 2 or more occasions, at least 12 weeks apart and include:

1. Anticardiolipin antibodies positive with IgG greater than 40 GPL and/or IgM greater than 40 MPL. (NOTE: IgA anticardiolipin antibodies are not currently considered to be a laboratory criterion.)
2. Anti-beta 2 glycoprotein I antibodies positive with IgG greater than 20 GPL and/or IgM greater than 10 MPL.
3. Lupus anticoagulant detected in plasma.

A diagnosis of APS is discouraged if less than 12 weeks or more than 5 years separates the positive laboratory and clinical criteria.

NOTE: Anticardiolipin antibodies may occur following acute bacterial or viral infections and in syphilis. Patients with such a history, who test positive, should be retested in 6-8 weeks to exclude transient antibodies that are usually not clinically significant.

Reference

1. J. Thrombosis and Haemostasis 2006; 4:295-306.

CPT Codes

86146x2, 86147x3.

Contacts

Last Updated

4/8/2021