Test Catalog

Test Id : CLPMG

Phospholipid (Cardiolipin) Antibodies, IgG and IgM, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Testing for phospholipid antibodies is indicated in the following clinical situations:

-Unexplained arterial or venous thrombosis

-A history of pregnancy morbidity defined as 1 or more unexplained deaths of a morphologically normal fetus beyond the 10th week of gestation, 1 or more premature births before 34 weeks of gestation caused by severe preeclampsia or placental insufficiency, or 3 or more unexplained, consecutive spontaneous abortions before the 10th week of gestation with no identifiable maternal hormonal or anatomic, or maternal or paternal chromosomal causes

-Presence of an unexplained cutaneous circulatory disturbance, eg, livido reticularis or pyoderma gangrenosum

-Presence of a systemic rheumatic disease especially lupus erythematosus

-Unexplained thrombocytopenia or hemolytic anemia

-Possible nonbacterial, thrombotic endocarditis

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
MCLIP Phospholipid Ab IgM, S Yes Yes
GCLIP Phospholipid Ab IgG, S Yes Yes

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Phospholip Ab (Cardiolip) IgM/IgG

Aliases
Lists additional common names for a test, as an aid in searching

Anti-Phospholipid Antibodies

Anticardiolipin Antibodies

Antiphospholipid Antibodies

Cardiolip

Cardiolipin Antibodies, IgG and IgM, Serum

Phospholip

Phospholipid Antibodies (Cardiolipin Antibodies), IgG and IgM, Serum

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Coagulation Test Request (T753)

-Renal Diagnostics Test Request (T830)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
Frozen 21 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Testing for phospholipid antibodies is indicated in the following clinical situations:

-Unexplained arterial or venous thrombosis

-A history of pregnancy morbidity defined as 1 or more unexplained deaths of a morphologically normal fetus beyond the 10th week of gestation, 1 or more premature births before 34 weeks of gestation caused by severe preeclampsia or placental insufficiency, or 3 or more unexplained, consecutive spontaneous abortions before the 10th week of gestation with no identifiable maternal hormonal or anatomic, or maternal or paternal chromosomal causes

-Presence of an unexplained cutaneous circulatory disturbance, eg, livido reticularis or pyoderma gangrenosum

-Presence of a systemic rheumatic disease especially lupus erythematosus

-Unexplained thrombocytopenia or hemolytic anemia

-Possible nonbacterial, thrombotic endocarditis

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The plasma membranes of mammalian cells are formed from phospholipids. Anionic phospholipids (eg, phosphatidylserine) are found on the cytoplasmic surface and neutral phospholipids (eg, phosphatidylcholine) predominate on the external surface. Membrane phospholipids participate in several important cellular functions including exchanging metabolites across membranes, transferring molecular signals and serving as a platform for the assembly of protein-lipid complexes.(1) Cellular activation is often accompanied by the translocation of anionic phospholipids to the external membrane surface. For example, during platelet-mediated blood coagulation phosphatidylserine is translocated from the inner platelet membrane and provides a surface for the assembly of the prothrombinase enzyme complex that catalyzes the formation of thrombin.

 

Complexes of negatively charged (anionic) phospholipids and endogenous plasma proteins provide epitopes recognized by natural autoantibodies.(2) Plasma from normal individuals contains low concentrations of natural IgG autoantibodies of moderate affinity. Pathologic levels of autoantibodies reflect loss of tolerance and increased production of antibodies. These autoantibodies are called phospholipid or cardiolipin antibodies when they are detected by immunoassays that employ anionic phospholipids as substrates. The most commonly used phospholipid substrate is cardiolipin. The term phospholipid antibody is actually a misnomer. The autoantibodies react with epitopes of protein molecules that associate noncovalently with reagent phospholipids. The best characterized phospholipid-binding protein is beta 2 glycoprotein 1 and most immunoassays for phospholipid antibodies employ a composite substrate consisting of cardiolipin plus beta-2 glycoprotein 1(beta-2 GP1beta-2 GP1). Beta-2 GP1 is a 326 amino acid polypeptide that contains 5 homologous domains of approximately 60 amino acids each. Most phospholipid antibodies bind to an epitope associated with domain 1 near the N-terminus. Autoantibodies can also be detected by the use of functional, phospholipid-dependent coagulation assays. Phospholipid antibodies detected by functional assays are often called lupus anticoagulants because they produce prolongation of phospholipid-dependent clotting in vitro. Not all phospholipid antibodies possess lupus anticoagulant activity.(3) Only those phospholipid antibodies that are capable of cross-linking beta-2 GP1 molecules can interact efficiently with phospholipid surfaces in functional coagulation assays. It is hypothesized that complexes formed in vivo between bivalent, natural autoantibodies and beta-2 GP1 bind to translocated, anionic phospholipid on activated platelets at sites of endothelial injury. This binding is believed to promote further platelet activation that may lead to thrombosis.

 

Phospholipid antibodies occur in patients with a variety of clinical signs and symptoms notably thrombosis (arterial or venous) pregnancy morbidity (unexplained fetal death, premature birth, severe preeclampsia, or placental insufficiency) unexplained cutaneous circulation disturbances (livido reticularis or pyoderma gangrenosum) thrombocytopenia or hemolytic anemia and nonbacterial thrombotic endocarditis. Phospholipid antibodies and lupus anticoagulants are found with increased frequency in patients with systemic rheumatic diseases especially lupus erythematosus. The term antiphospholipid syndrome (APS) or Hughes syndrome is used to describe the triad of thrombosis, recurrent fetal loss and thrombocytopenia accompanied by phospholipid antibodies or a lupus anticoagulant. The diagnosis of APS requires 1 or more of the above mentioned clinical findings plus positive test results for phospholipid antibodies (> or =40 GPL or MPL) or positive tests for a lupus anticoagulant on more than 1 occasion separated by at least 6 weeks.(4)

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<15.0 MPL or GPL (negative)

15.0-39.9 MPL or GPL (weakly positive)

40.0-79.9 MPL or GPL (positive)

> or =80.0 MPL or GPL  (strongly positive)

MPL refers to IgM Phospholipid Units. One MPL unit is 1 microgram of IgM antibody.

GPL refers to IgG Phospholipid Units. One GPL unit is 1 microgram of IgG antibody

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Positive and strongly positive results for phospholipid antibodies (> or =40 GPL and/or MPL) are a diagnostic criterion for antiphospholipid syndrome (APS). Lesser levels of phospholipid antibodies and antibodies of the IgA isotype may occur in patients with clinical signs of APS but the results are not considered diagnostic.

 

Detection of phospholipid antibodies is not affected by anticoagulant treatment.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The immunoassay for phospholipid antibodies does not distinguish between autoantibodies and antibodies produced in response to infectious agents or as epiphenomena following thrombosis. For this reason, a single positive test result is not sufficient to meet accepted serologic criteria for the diagnosis of antiphospholipid syndrome (APS).

 

Comparative studies and interlaboratory proficiency surveys indicate that results of phospholipid antibody tests can be highly variable and results obtained with different commercial immunoassays may yield substantially different results.(5,6)

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bevers EM, Comfurius P, Dekkers DW, et al: Lipid translocation across the plasma membrane of mammalian cells. Biochim Biophys Acta 1999;1439:317-330

2. Arnout J, Vermylen J: Current status and implications of autoimmune antiphospholipid antibodies in relation to thrombotic disease. J Thromb Haemost 2003;1:931-942

3. Proven A, Bartlett RP, Moder KG, et al: Clinical importance of positive test results for lupus anticoagulant and anticardiolipin antibodies. Mayo Clin Proc 2004;79:467-475

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. Fontaine MJ, Jacob GL, Nichols WL, et al: Comparative evaluation of three assays for anti-cardiolipin antibodies. J Autoimmun 2000;15(2):A56

6. Favaloro EJ, Wong RC, Silvertrini R, et al: A multilaboratory peer assessment quality assurance program-based evaluation of anticardiolipin antibody, and beta 2 glycoprotein 1 antibody testing. Semin Thromb Hemost 2005;31(1):73-84

Method Description
Describes how the test is performed and provides a method-specific reference

Purified cardiolipin 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 cardiolipin antibodies present to bind to the immobilized antigen. Unbound sample is washed away and an enzyme-labeled antihuman IgM or IgG 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. After stopping the enzymatic production of colored product, the presence or absence of cardiolipin antibody is determined by comparing the sample optical density with that of a 5-point calibration curve. Results are reported out semiquantitatively in standard IgM or IgG anticardiolipin units (MPL and GPL).(Package inserts: QUANTA Lite ACA IgM III September 2015 Revision 21 and QUANTA Lite ACA IgG III Inova Diagnostics February 2015 Revision 22)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

See Individual Mayo Test IDs.

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US 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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86147 x 2

LOINC® Information

Test Id Test Order Name Order LOINC Value
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
CLPMG Phospholip Ab (Cardiolip) IgM/IgG 24319-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
GCLIP Phospholipid Ab IgG, S 3181-5
MCLIP Phospholipid Ab IgM, S 3182-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports