JANUARY 2019

admin Publications February 12, 2019April 3, 2021

Thromb Res. 2019 Jan 18;175:32-36 — The comparison of real world and core laboratory antiphospholipid antibody ELISA results from antiphospholipid syndrome alliance for clinical trials & international networking (APS ACTION) clinical database and repository analysis — Sciascia S, Willis R, Pengo V, Krilis S, Andrade D, Tektonidou MG, Ugarte A, Chighizola C, Branch DW, Levy RA, Nalli C, Fortin PR, Petri M, Rodriguez E, Rodriguez-Pinto I, Atsumi T, Nascimento I, Rosa R, Banzato A, Erkan D, Cohen H, Efthymiou M, Mackie I, Bertolaccini ML on Behalf of APS ACTION.

The APS ACTION International Clinical Database and Repository includes a secure web-based data capture system storing patient information including demographics, antiphospholipid antibodies (aPL)-related medical history, and aPL tests. Despite efforts at harmonization, inter-assay variability remains a problem in aPL testing. As a clinical repository open to researchers, ensuring comparability between assays and consistency in results between APS ACTION laboratories is essential to the validity of studies emerging from this network.

OBJECTIVE:

To assess the level of agreement between an aPL-registry inclusion and core laboratory (core lab) anticardiolipin antibody (aCL) and anti-β₂-glycoprotein-I antibody (aβ₂GPI) ELISA testing results.

METHODS:

Patients are recruited from 25 international centers based on positive aPL tests at inclusion. All samples are retested at the corresponding national APS ACTION core lab to confirm aPL positivity based on standard validated protocols. We analysed the categorical agreement, degree of linear association, and correlation between inclusion (local laboratory) and core lab aPL tests. Samples were included in this study only if results of aPL testing with ELISA at baseline were available.

RESULTS:

497 registry samples underwent confirmatory aPL tests. Categorical agreement between the inclusion and core lab values, as expressed by Cohen’s kappa coefficients, ranged between 0.61 and 0.80 (as substantial agreement). The correlation between quantitative results in the aCL and aβ₂GPI was better for IgM and IgA compared to IgG (Spearman rho 0.789 and 0.666 vs. 0.600 for aCL and rho 0.892 and 0.744 vs. 0.432 for aβ₂GPI).

CONCLUSIONS:

The results of inclusion for aCL and aβ₂GPI tests used for recruitment into the registry were in agreement to the results obtained by the APS ACTION core laboratories; aCL and aβ₂GPI results showed very good categorical agreement. This agreement increased when considering high titer (>40 units) samples. APS ACTION is a reliable and useful research resource for APS.

Four Antiphospholipid Syndrome (APS) Organizations – APS ACTION • APS FOUNDATION OF AMERICA • APS FOUNDATION OF AUSTRALIA • APS SUPPORT UK – Jointly Support World Thrombosis Day

admin News December 2, 2018

October 2018 – World Thrombosis Day Support Campaign.

Patient Questions (with answers) & Stories (Challenges, Concerns, Uplifitng and Success Stories) Received During Our 2018 World Thrombosis Day Support Campaign.

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APS ACTION Presentations at the American College of Rheumatology (ACR) 2018 Annual Scientific Meeting

admin News November 2, 2018November 27, 2018

October 2018 –

APS ACTION presented three studies during the 2018 American College of Rheumatology Annual Scientific Meeting (October 2018, Chicago, IL).

Sevim E, Andrade D, Banzato A, Tektonidou M, Ugarte A, Chighizola CB, Ji L, Branch D, Ramires de Jesus G, Andreoli L, Petri M, Cervera R, Knight JS, Atsumi T, Erkan D on Behalf of APS ACTION. Pregnancy Outcomes of Antiphospholipid Antibody Positive Patients: Prospective Results from Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository (“Registry”) [abstract].Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/pregnancy-outcomes-of-antiphospholipid-antibody-positive-patients-prospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-clinical-da/. Accessed November 18, 2018.

Sevim E, Zisa DF, Andrade D, Pengo V, Tektonidou M, Ugarte A, Gerosa M, Ji L, Efthymiou M, Ramires de Jesus G, Branch D, Nalli C, Sciascia S, Belmont HM, Fortin PR, Petri M, Rodriguez-Almaraz E, Quintana R, Knight JS, Willis R, Atsumi T, Bertolaccini ML, Erkan D, Barbhaiya M on Behalf of APS ACTION. Clinical and Laboratory Characteristics of Persistently Antiphospholipid Antibody Positive Patients: Retrospective Results from Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository (“Registry”) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).
https://acrabstracts.org/abstract/clinical-and-laboratory-characteristics-of-persistently-antiphospholipid-antibody-positive-patients-retrospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international/. Accessed November 18, 2018.

Sevim E, Unlu O, Andrade D, Banzato A, Tektonidou M, Ugarte A, Gerosa M, Cohen H, Branch D, Ramires de Jesus G, Tincani A, Fortin PR, Petri M, Rodriguez I, Knight JS, Atsumi T, Willis R, Roubey R, Erkan D on Behalf of APS ACTION. First and Recurrent Thrombosis Risk after 1897 Patient-Years of Follow-up: Prospective Results from Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Clinical Database and Repository (“Registry”) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).
https://acrabstracts.org/abstract/first-and-recurrent-thrombosis-risk-after-1897-patient-years-of-follow-up-prospective-results-from-antiphospholipid-syndrome-alliance-for-clinical-trials-and-international-networking-aps-action-cli/. Accessed November 18, 2018.