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Test Code PSPTG Phosphatidylserine/Prothrombin Antibody, IgG, Serum

Useful For

Detecting IgG antibodies against phosphatidylserine/prothrombin complex in patients with strong suspicion of antiphospholipid syndrome (APS) who are negative for the APS criteria laboratory tests (lupus anticoagulant, IgG and IgM anticardiolipin/beta 2-glycoprotein I and anti-beta 2-glycoprotein I antibodies)

 

May be useful for the evaluation of patients with prior positive lupus anticoagulant results who are on direct oral anticoagulant therapy

 

May be useful as a risk marker for thrombosis in antiphospholipid antibody carriers

Reporting Name

PS/PT Ab, IgG, S

Specimen Type

Serum


Ordering Guidance


Cardiolipin and beta-2 glycoprotein testing are the first-tier test options for most patients. Phosphatidylserine/prothrombin antibodies are considered part of the second-tier workup.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat treated Reject

Clinical Information

The 2023 American College of Rheumatology/European Alliance of Associations for Rheumatology antiphospholipid syndrome (APS) classification criteria includes an entry criterion of at least one positive antiphospholipid antibody (aPL) test within 3 years of identification of an aPL-associated clinical criterion, followed by additive weighted criteria (score range 1-7 points each) clustered into 6 clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and 2 laboratory domains (lupus anticoagulant functional coagulation assays, and solid-phase enzyme-linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti-beta 2-glycoprotein I antibodies) (1)Cardiolipin is an anionic phospholipid that interacts with the protein cofactor beta 2-glycoprotein I. Lupus anticoagulant (LA) is an indirect assessment for the presence of antiphospholipid antibodies, which is evident in the in vitro prolongation of phospholipid-dependent coagulation.(2) Anticardiolipin and anti-beta 2-glycoprotein I antibodies are detected in solid-phases immunoassays using beta 2-glycoprotein I-dependent cardiolipin/or beta 2-glycoprotein I alone as substrate, respectively.(2,3)

 

There is evidence from multiple studies to suggest that patients with APS may develop autoantibodies to other phospholipid/protein complexes, specifically phosphatidylserine/prothrombin (PS/PT).(4-9) Like beta 2-glycoprotein-dependent I cardiolipin, PS/PT is a complex composed of the anionic phospholipid phosphatidylserine and the protein cofactor prothrombin. In a systematic review, Sciascia et al demonstrated that the presence of anti-PS/PT IgG antibodies is an independent risk factor for arterial and/or venous thrombotic events, with odds ratio (OR) of 5.11 (95% CI: 4.2-6.3).(4) A multicenter study showed that IgG anti-PS/PT were more prevalent in APS patients (51%) than in those without (9%), OR 10.8, 95% CI (4.0-29.3), p <0.0001.(5) Furthermore, a number of studies have shown clinical and laboratory evidence that PS/PT antibodies may be a useful second-line test for the evaluation of patients at-risk or suspected with suspected APS, particularly for those individuals with evidence of thrombosis or abnormal LA testing.(6,7) While anti-PS/PT antibodies were highly prevalent and correlated with other anti-PL antibodies, IgG anti-PS/PT conferred a high risk for thrombosis (8,9) but not for pure hematologic involvement.(9) These antibodies may also be seen in patients with other autoimmune diseases such as systemic lupus erythematosus.(5,8) In individuals who test positive for antiphospholipid antibodies without clinical features of APS (carriers), the cumulative incidence rate of thrombotic events has also been reported to be significantly higher for anti-PS/PT IgG positive than anti-PS/PT IgM positive subjects.(10)

Reference Values

Negative ≤30.0 U

Borderline 30.1-40.0 U

Positive ≥40.1 U

Interpretation

A positive and persistent result for anti-phosphatidylserine/prothrombin complex IgG antibodies may be suggestive of a diagnosis of antiphospholipid syndrome (APS) in patients with evidence of arterial, venous, or specific pregnancy-related morbidities. These antibodies may also exist prior to the occurrence APS clinical manifestations as well as in patients with other systemic autoimmune diseases such systemic lupus erythematosus.

 

Anti-phosphatidylserine/prothrombin complex IgG antibodies have relatively higher correlations with positive results for lupus anticoagulant than the IgM isotype as well as significant risk for APS-associated thrombotic events compared to the IgM isotype in antiphospholipid antibody carriers.

 

A negative result does not exclude a diagnosis of APS, as other phospholipid and/or protein antibodies are also associated with this disorder.

Cautions

A diagnosis of antiphospholipid syndrome (APS) should not be based only on the presence of anti-phosphatidylserine/prothrombin antibodies. Results must be interpreted in the appropriate clinical context.

 

A negative result for anti-phosphatidylserine/prothrombin IgG antibodies does not exclude the diagnosis of APS.

 

Anti-phosphatidylserine/prothrombin IgG antibodies are not yet included in the classification criteria for APS.

Method Description

The QUANTA Lite aPS/PT IgG assay is an enzyme-linked immunosorbent assay. Briefly, purified phosphatidylserine/prothrombin (PS/PT) complex is coated onto a 96-well plate. Calibrators, controls, and diluted patient samples are added to the wells of the plate. If present, IgG antibodies to the PS/PT complex will bind during an incubation step. After a wash step, an antihuman IgG horseradish peroxidase-labelled conjugate is added. After another incubation and wash step, a peroxidase substrate solution is added, which will change color in the presence of the conjugated enzyme. Lastly, the reaction is stopped by the addition of 0.44 M sulfuric acid. The absorbance of the colored produced is proportional to the amount of IgG PSPT antibodies in the sample. Control and patient results are calculated based on a curve generated from the kit calibrators.(Packet insert: QUANTA Lite aPS/PT IgG. INOVA Diagnostics; Rev 2, 01/2016)

Day(s) Performed

Wednesday

Report Available

2 to 8 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86148

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PSPTG PS/PT Ab, IgG, S 85359-8

 

Result ID Test Result Name Result LOINC Value
PSPTG PS/PT Ab, IgG, S 85359-8

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.