Test Catalog

Test Id : PSPTM

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Phosphatidylserine/Prothrombin Antibody, IgM, Serum

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Overview

Test Catalog

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

Detecting IgM 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

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

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

PS/PT Ab, IgM, S

Specimen Type
Describes the specimen type validated for testing

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

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
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

Detecting IgM 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

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

According to the 2006 revised Sapporo classification criteria, a diagnosis of antiphospholipid syndrome (APS) is based on the presence of specific pregnancy-related morbidities, arterial or venous thrombosis in association with persistent lupus anticoagulant (LA), anticardiolipin IgG/IgM or anti-beta 2-glycoprotein I IgG/IgM antibodies.(1) Cardiolipin is an anionic phospholipid that interacts with the protein cofactor beta 2-glycoprotein I. 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 LAC 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
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.

Negative < or =30.0 U

Borderline 30.1-40.0 U

Positive > or =40.1 U

Interpretation
Provides information to assist in interpretation of the test results

A positive and persistent result for anti-phosphatidylserine/prothrombin complex IgM 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.

 

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

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

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.

 

Anti-phosphatidylserine/prothrombin complex IgM antibodies have a lower risk for APS-associated thrombotic events compared to the IgG isotype in carriers.

 

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

 

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

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

1. Miyakis S, Lockshin MD, Atsumi T, et al: International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006 Feb;4(2):295-306. doi: 10.1111/j.1538-7836.2006.01753.x

2. Pengo V, Bison E, Denas G, Jose SP, Zoppellaro G, Banzato A: Laboratory diagnostics of antiphospholipid syndrome. Semin Thromb Hemost. 2018 Jul;44(5):439-444. doi: 10.1055/s-0037-1601331

3. Tebo AE. Laboratory evaluation of antiphospholipid syndrome: An update on autoantibody testing. Clin Lab Med. 2019 Dec;39(4):553-565. doi: 10.1016/j.cll.2019.07.004

4. Sciascia S, Sanna G, Murru V, Roccatello D, Khamashta MA, Bertolaccini ML: Anti-prothrombin (aPT) and anti-phosphatidylserine/prothrombin (aPS/PT) antibodies and the risk of thrombosis in the antiphospholipid syndrome: A systematic review. Thromb Haemost. 2014 Feb;111(2):354-364. doi: 10.1160/TH13-06-0509

5. Amengual O, Forastiero R, Sugiura-Ogasawara M, et al: Evaluation of phosphatidylserine-dependent antiprothrombin antibody testing for the diagnosis of antiphospholipid syndrome: results of an international multicentre study. Lupus. 2017 Mar;26(3):266-276. doi: 10.1177/0961203316660203

6. Heikal NM, Jaskowski TD, Malmberg E, Lakos G, Branch DW, Tebo AE: Laboratory evaluation of anti-phospholipid syndrome: A preliminary prospective study of phosphatidylserine/prothrombin antibodies in an at-risk patient cohort. Clin Exp Immunol. 2015 May;180(2):218-226. doi: 10.1111/cei.12573

7. Nakamura H, Oku K, Amengual O, et al: First-line, non-criterial antiphospholipid antibody testing for the diagnosis of antiphospholipid syndrome in clinical practice: A combination of anti-beta 2 -glycoprotein I domain I and anti-phosphatidylserine/prothrombin complex antibodies tests. Arthritis Care Res (Hoboken). 2018 Apr 70(4):627-634

8. Radin M, Foddai SG, Cecchi I, et al: Antiphosphatidylserine/prothrombin antibodies: An update on their association with clinical manifestations of antiphospholipid syndrome. Thromb Haemost. 2020 Apr;120(4):592-598. doi: 10.1055/s-0040-1705115

9. Nunez-Alvarez CA, Hernandez-Molina G, Bermudez-Bermejo P, et al: Prevalence and associations of anti-phosphatidylserine/prothrombin antibodies with clinical phenotypes in patients with primary antiphospholipid syndrome: aPS/PT antibodies in primary antiphospholipid syndrome. Thromb Res. 2019 Feb;174:141-147. doi: 10.1016/j.thromres.2018.12.023

10. Tonello M, Mattia E, Favaro M, et al: IgG phosphatidylserine/prothrombin antibodies as a risk factor of thrombosis in antiphospholipid antibody carriers. Thromb Res. 2019 May;177:157-160. doi: 10.1016/j.thromres.2019.03.006

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

The QUANTA Lite sPS/PT IgM 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, IgM antibodies to the PS/PT complex will bind during an incubation step. After a wash step, an antihuman IgM 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 IgM 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, IgM ELISA kit. INOVA Diagnostics; Rev. 4, 09/2018)

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.

Wednesday

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.

2 to 8 days

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

14 days

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 account representative. 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 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.

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.

86148

LOINC® Information
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.

Test Id Test Order Name Order LOINC Value
PSPTM PS/PT Ab, IgM, S 85358-0
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.
PSPTM PS/PT Ab, IgM, S 85358-0

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 | 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