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Doruk Erkan - One of the best experts on this subject based on the ideXlab platform.

  • comparison of real world and core laboratory lupus anticoagulant results from the antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository
    Journal of Thrombosis and Haemostasis, 2019
    Co-Authors: M Efthymiou, Danieli Andrade, Doruk Erkan, I Mackie, P J Lane, Rohan Willis, Savino Sciascia, Steven Krillis, E Bison, Margarete B G Vendramini
    Abstract:

    BACKGROUND: Variability remains a challenge in lupus anticoagulant (LA) testing. OBJECTIVE: To validate LA test performance between Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Core laboratories and examine agreement in LA status between Core and local/hospital laboratories contributing patients to this prospective registry. METHODS: Five Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Non-anticoagulated registry samples were retested at the corresponding regional Core laboratories and anticoagulated samples at a single Core laboratory. Categorical agreement and discrepancies in LA status between Core and local/hospital laboratories were analyzed. RESULTS: Clotting times for the reference/characterized plasmas used for normalized ratios were similar between Core laboratories (CV <4%); precision and agreement for LA positive/negative plasma were similar (all CV ≤5%) in the four laboratories that completed both parts of the validation exercise; 418 registry samples underwent LA testing. Agreement for LA positive/negative status between Core and local/hospital laboratories was observed in 87% (115/132) non-anticoagulated and 77% (183/237) anticoagulated samples. However, 28.7% (120/418) of samples showed discordance between the Core and local/hospital laboratories or equivocal LA results. Some of the results of the local/hospital laboratories might have been unreliable in 24.7% (41/166) and 23% (58/252) of the total non-anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance. CONCLUSIONS: Laboratories can achieve good agreement in LA performance by use of the same reagents, analyzer type, and protocols. The standardized Core laboratory results underpin accurate interpretation of APS ACTION clinical data.

  • antiphospholipid syndrome alliance for clinical trials and International Networking aps action
    2017
    Co-Authors: Medha Barbhaiya, Danieli Andrade, Maria Laura Bertolaccini, Doruk Erkan
    Abstract:

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) (www.apsaction.org) is the first International network created to design and conduct large-scale, multicenter clinical trials and research studies in individuals with autoimmune antiphospholipid antibodies (aPL) with/without aPL-related clinical symptoms. Since 2010, through the dedication APS ACTION members, collaborative International projects are underway. This chapter provides a summary of the organization’s structure, ongoing research efforts, and recent accomplishments and discusses future directions.

  • AntiPhospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION): 5-Year Update
    Current Rheumatology Reports, 2016
    Co-Authors: Medha Barbhaiya, Danieli Andrade, Doruk Erkan
    Abstract:

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) is the first-ever International network created to design and conduct large-scale, multicenter clinical trials and research in persistently antiphospholipid antibody (aPL)-positive patients. Since its inception in 2010, the APS ACTION has made important strides toward our goal of International research collaboration and data sharing. Through the dedication and hard work of 50 APS ACTION members, collaborative International projects are currently underway including a multicenter web-based registry and repository of aPL-positive patients, a randomized controlled clinical trial assessing the efficacy of hydroxychloroquine for primary thrombosis prevention in persistently aPL-positive but thrombosis-free patients, standardization of aPL testing through the use of core laboratories worldwide, identification of the limitations in the existing aPL/APS literature, and conducting observational research studies to further our understanding of the disease. Thus far, APS ACTION has held annual workshops and summits with the aim of facilitating International collaboration and developing initiatives to recruit young scholars to APS research. This paper describes updates related to the organization’s structure, ongoing research efforts, and recent accomplishments and discusses future directions.

  • fri0314 antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository analysis the impact of systemic lupus erythematosus on the clinical phenotype of antiphospholipid antibody positiv
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Stephane Zuily, Danieli Andrade, Doruk Erkan, Maria G Tektonidou
    Abstract:

    Background APS ACTION International Clinical Database and Repository (“Registry”) was created to study the natural course of persistently antiphospholipid antibodies (aPL)-positive patients with or without autoimmune disorders over 10 years. The main autoimmune disease associated with aPL is Systemic Lupus Erythematosus (SLE); limited data exist on the impact of SLE on the clinical phenotype of persistently aPL-positive patients. Objectives Our objective was to compare the prevalence of clinical and laboratory characteristics of aPL-positive patients with or without SLE. Methods A secure web-based data capture system is used to store patient demographics, pertinent aPL history, and aPL profile. The inclusion criteria include aPL positivity according to the Updated Sapporo Classification Criteria. Only patients fulfilling the ACR SLE Classification Criteria and those with no other autoimmune diseases were included in this cross sectional analysis to study the impact of SLE on aPL-positive patients. Baseline clinical characteristics were compared using χ 2 or t-tests accordingly. Results As of June 2015, 573 aPL-positive patients recruited from 24 centers; 130 (22.7%) were excluded due to other or overlapping autoimmune diseases, SLE-like disease (fulfilling 3/11 ACR SLE Classification Criteria), or missing data. The mean ages (± SD) of individuals with persistently positive aPL but without other autoimmune diseases (“aPL only”) (female: 218, 73%), and of those with SLE (“aPL with SLE”) (female: 110, 77%) were 44±13 and 49±77, respectively. The majority of patients were Caucasians in both groups (62% and 65%, respectively), followed by Latin Americans (19.3% and 10.5%). Table shows the distribution of the clinical and laboratory characteristics (historically and/or at registry entry). The frequency of criteria and non-criteria APS manifestations was not different between two groups except persistent thrombocytopenia and autoimmune hemolytic anemia, which were more common in the “aPL with SLE” group (14% vs 28% and 2% vs 12%, respectively; both p≤0.001). Nephrotic syndrome, chronic or end-stage renal disease, and hypocomplementemia were also more common in the “apL with SLE” group. Conclusions Concomitant SLE diagnosis in persistently aPL-positive patients is associated with an increased risk of thrombocytopenia, hemolytic anemia, nephrotic syndrome, chronic or end-stage renal disease, and hypocomplementemia; however the risk of other non-criteria manifestations, thrombosis, and pregnancy morbidity remains the same. Acknowledgement APS ACTION Members. Disclosure of Interest None declared

  • ab1071 antiphospholipid syndrome alliance for clinical trials and International Networking aps action core laboratory validation exercise comparison of chemiluminescence immunoassay cia and enzyme linked immunosorbant assay elisa
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Maria Laura Bertolaccini, Danieli Andrade, Rohan Willis, Alessandra Banzato, Vittorio Pengo, Gabriella Lakos, Steven A Krilis, Doruk Erkan
    Abstract:

    Background APS ACTION International Clinical Database and Repository was created to study the natural course of disease over 10 years in persistently aPL-positive patients with/without other systemic autoimmune diseases. The protocol involves testing for anticardiolipin antibodies (aCL) and anti-β2glycoprotein I antibodies (aβ2GPI) at five different International core laboratories in samples collected at multiple sites. Although all core laboratories use the same ELISA kits, APS ACTION core laboratory directors agreed that an exchange of samples to assess intra- and inter-laboratory variability is crucial to establish whether an acceptable agreement among the core labs can be achieved. As part of the this validation exercise, two different assays were used. Objectives To assess between-laboratory agreement obtained with a novel antiphospholipid (aPL) chemiluminescence immunoassay (CIA), and compare the results to those obtained with ELISA assays. Methods Blinded serum samples from aPL positive patients and controls (n=30) were distributed to the five APS ACTION core laboratories. All samples were tested for IgG, IgM and IgA aCL and aβ2GPI with the FDA cleared QUANTA Flash® CIA and QUANTA Lite® ELISA kits (Inova Diagnostics). For every sample, the average, SD and %CV of the values were calculated. Between laboratory precision was considered acceptable if %CV was less than 20%. Results Categorical agreement between the two methods was 100%, 97% and 77% for IgG, IgM and IgA aCL, respectively, and 87%, 93% and 77% for IgG, IgM and IgA ab2GPI, respectively. The correlation between quantitative results was good (Spearman rho 0.917, 0.809 and 0.893 for IgG, IgM and IgA aCL, respectively; rho 0.938, 0.766 and 0.78 for IgG, IgM and IgA anti-b2GPI. All p values Conclusions IgG and IgM aCL and aβ2GPI results showed good agreement between CIA and ELISA. Agreement was lower for IgA assays due to borderline samples being positive for CIA (a very sensitive test) and negative for the ELISA. Based on the evaluations performed in the APS ACTION Core Laboratories, CIA and ELISA tests displayed substantially equivalent performance for the detection of aCL and aβ2GPI. QUANTA Flash® CIA, a fully automated assay, however, showed higher level of reproducibility, making inter-laboratory comparisons more reliable. Disclosure of Interest M. L. Bertolaccini: None declared, R. Willis: None declared, G. Lakos Employee of: Inova Diagnostics Inc, D. Andrade: None declared, V. Pengo: None declared, A. Banzato: None declared, S. Krilis: None declared, D. Erkan: None declared

Danieli Andrade - One of the best experts on this subject based on the ideXlab platform.

  • comparison of real world and core laboratory lupus anticoagulant results from the antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository
    Journal of Thrombosis and Haemostasis, 2019
    Co-Authors: M Efthymiou, Danieli Andrade, Doruk Erkan, I Mackie, P J Lane, Rohan Willis, Savino Sciascia, Steven Krillis, E Bison, Margarete B G Vendramini
    Abstract:

    BACKGROUND: Variability remains a challenge in lupus anticoagulant (LA) testing. OBJECTIVE: To validate LA test performance between Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Core laboratories and examine agreement in LA status between Core and local/hospital laboratories contributing patients to this prospective registry. METHODS: Five Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Non-anticoagulated registry samples were retested at the corresponding regional Core laboratories and anticoagulated samples at a single Core laboratory. Categorical agreement and discrepancies in LA status between Core and local/hospital laboratories were analyzed. RESULTS: Clotting times for the reference/characterized plasmas used for normalized ratios were similar between Core laboratories (CV <4%); precision and agreement for LA positive/negative plasma were similar (all CV ≤5%) in the four laboratories that completed both parts of the validation exercise; 418 registry samples underwent LA testing. Agreement for LA positive/negative status between Core and local/hospital laboratories was observed in 87% (115/132) non-anticoagulated and 77% (183/237) anticoagulated samples. However, 28.7% (120/418) of samples showed discordance between the Core and local/hospital laboratories or equivocal LA results. Some of the results of the local/hospital laboratories might have been unreliable in 24.7% (41/166) and 23% (58/252) of the total non-anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance. CONCLUSIONS: Laboratories can achieve good agreement in LA performance by use of the same reagents, analyzer type, and protocols. The standardized Core laboratory results underpin accurate interpretation of APS ACTION clinical data.

  • 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
    Thrombosis Research, 2019
    Co-Authors: Savino Sciascia, Danieli Andrade, Rohan Willis, Maria G Tektonidou, Vittorio Pengo, Amaia Ugarte, Steven A Krilis, Cecilia Beatrice Chighizola, Ware D Branch, Roger A Levy
    Abstract:

    Abstract Background 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.

  • factors associated with first thrombosis in patients presenting with obstetric antiphospholipid syndrome aps in the aps alliance for clinical trials and International Networking clinical database and repository a retrospective study
    British Journal of Obstetrics and Gynaecology, 2018
    Co-Authors: G R De Jesus, Medha Barbhaiya, Danieli Andrade, Savino Sciascia, Maria G Tektonidou, Alessandra Banzato, Vittorio Pengo, L Ji, P L Meroni, Amaia Ugarte
    Abstract:

    OBJECTIVE To evaluate the subsequent rate of thrombosis among women with obstetric antiphospholipid syndrome (Ob-APS) in a multicentre database of antiphospholipid antibody (aPL)-positive patients, and the clinical utility of the adjusted Global Antiphospholipid Syndrome Score (aGAPSS), a validated tool to assess the likelihood of developing new thrombosis, in this group of patients. DESIGN Retrospective study. SETTING The Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking Clinical Database and Repository. POPULATION Women with Ob-APS. METHODS Comparison of clinical and laboratory characteristics and measurement of aGAPSS in women with Ob-APS, with or without thrombosis, after initial pregnancy morbidity (PM). MAIN OUTCOME MEASURES Risk factors for thrombosis and aGAPSS. RESULTS Of 550 patients, 126 had Ob-APS; 74/126 (59%) presented with thrombosis, and 47 (63%) of these women developed thrombosis after initial PM, in a mean time of 7.6 ± 8.2 years (4.9/100 patient years). Younger age at diagnosis of Ob-APS, additional cardiovascular risk factors, superficial vein thrombosis, heart valve disease, and multiple aPL positivity increased the risk of first thrombosis after PM. Women with thrombosis after PM had a higher aGAPSS compared with women with Ob-APS alone [median 11.5 (4-16) versus 9 (4-13); P = 0.0089]. CONCLUSION Based on a retrospective analysis of our multicentre aPL database, 63% of women with Ob-APS developed thrombosis after initial obstetric morbidity; additional thrombosis risk factors, selected clinical manifestations, and high-risk aPL profile increased the risk. Women with subsequent thrombosis after Ob-APS had a higher aGAPSS at entry to the registry. We believe that aGAPSS is a valid tool to improve risk stratification in aPL-positive women. TWEETABLE ABSTRACT More than 60% of women with obstetric antiphospholipid syndrome had thrombosis after initial pregnancy morbidity.

  • antiphospholipid syndrome alliance for clinical trials and International Networking aps action
    2017
    Co-Authors: Medha Barbhaiya, Danieli Andrade, Maria Laura Bertolaccini, Doruk Erkan
    Abstract:

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) (www.apsaction.org) is the first International network created to design and conduct large-scale, multicenter clinical trials and research studies in individuals with autoimmune antiphospholipid antibodies (aPL) with/without aPL-related clinical symptoms. Since 2010, through the dedication APS ACTION members, collaborative International projects are underway. This chapter provides a summary of the organization’s structure, ongoing research efforts, and recent accomplishments and discusses future directions.

  • AntiPhospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION): 5-Year Update
    Current Rheumatology Reports, 2016
    Co-Authors: Medha Barbhaiya, Danieli Andrade, Doruk Erkan
    Abstract:

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) is the first-ever International network created to design and conduct large-scale, multicenter clinical trials and research in persistently antiphospholipid antibody (aPL)-positive patients. Since its inception in 2010, the APS ACTION has made important strides toward our goal of International research collaboration and data sharing. Through the dedication and hard work of 50 APS ACTION members, collaborative International projects are currently underway including a multicenter web-based registry and repository of aPL-positive patients, a randomized controlled clinical trial assessing the efficacy of hydroxychloroquine for primary thrombosis prevention in persistently aPL-positive but thrombosis-free patients, standardization of aPL testing through the use of core laboratories worldwide, identification of the limitations in the existing aPL/APS literature, and conducting observational research studies to further our understanding of the disease. Thus far, APS ACTION has held annual workshops and summits with the aim of facilitating International collaboration and developing initiatives to recruit young scholars to APS research. This paper describes updates related to the organization’s structure, ongoing research efforts, and recent accomplishments and discusses future directions.

Maria G Tektonidou - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Thrombosis Research, 2019
    Co-Authors: Savino Sciascia, Danieli Andrade, Rohan Willis, Maria G Tektonidou, Vittorio Pengo, Amaia Ugarte, Steven A Krilis, Cecilia Beatrice Chighizola, Ware D Branch, Roger A Levy
    Abstract:

    Abstract Background 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.

  • factors associated with first thrombosis in patients presenting with obstetric antiphospholipid syndrome aps in the aps alliance for clinical trials and International Networking clinical database and repository a retrospective study
    British Journal of Obstetrics and Gynaecology, 2018
    Co-Authors: G R De Jesus, Medha Barbhaiya, Danieli Andrade, Savino Sciascia, Maria G Tektonidou, Alessandra Banzato, Vittorio Pengo, L Ji, P L Meroni, Amaia Ugarte
    Abstract:

    OBJECTIVE To evaluate the subsequent rate of thrombosis among women with obstetric antiphospholipid syndrome (Ob-APS) in a multicentre database of antiphospholipid antibody (aPL)-positive patients, and the clinical utility of the adjusted Global Antiphospholipid Syndrome Score (aGAPSS), a validated tool to assess the likelihood of developing new thrombosis, in this group of patients. DESIGN Retrospective study. SETTING The Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking Clinical Database and Repository. POPULATION Women with Ob-APS. METHODS Comparison of clinical and laboratory characteristics and measurement of aGAPSS in women with Ob-APS, with or without thrombosis, after initial pregnancy morbidity (PM). MAIN OUTCOME MEASURES Risk factors for thrombosis and aGAPSS. RESULTS Of 550 patients, 126 had Ob-APS; 74/126 (59%) presented with thrombosis, and 47 (63%) of these women developed thrombosis after initial PM, in a mean time of 7.6 ± 8.2 years (4.9/100 patient years). Younger age at diagnosis of Ob-APS, additional cardiovascular risk factors, superficial vein thrombosis, heart valve disease, and multiple aPL positivity increased the risk of first thrombosis after PM. Women with thrombosis after PM had a higher aGAPSS compared with women with Ob-APS alone [median 11.5 (4-16) versus 9 (4-13); P = 0.0089]. CONCLUSION Based on a retrospective analysis of our multicentre aPL database, 63% of women with Ob-APS developed thrombosis after initial obstetric morbidity; additional thrombosis risk factors, selected clinical manifestations, and high-risk aPL profile increased the risk. Women with subsequent thrombosis after Ob-APS had a higher aGAPSS at entry to the registry. We believe that aGAPSS is a valid tool to improve risk stratification in aPL-positive women. TWEETABLE ABSTRACT More than 60% of women with obstetric antiphospholipid syndrome had thrombosis after initial pregnancy morbidity.

  • fri0314 antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository analysis the impact of systemic lupus erythematosus on the clinical phenotype of antiphospholipid antibody positiv
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Stephane Zuily, Danieli Andrade, Doruk Erkan, Maria G Tektonidou
    Abstract:

    Background APS ACTION International Clinical Database and Repository (“Registry”) was created to study the natural course of persistently antiphospholipid antibodies (aPL)-positive patients with or without autoimmune disorders over 10 years. The main autoimmune disease associated with aPL is Systemic Lupus Erythematosus (SLE); limited data exist on the impact of SLE on the clinical phenotype of persistently aPL-positive patients. Objectives Our objective was to compare the prevalence of clinical and laboratory characteristics of aPL-positive patients with or without SLE. Methods A secure web-based data capture system is used to store patient demographics, pertinent aPL history, and aPL profile. The inclusion criteria include aPL positivity according to the Updated Sapporo Classification Criteria. Only patients fulfilling the ACR SLE Classification Criteria and those with no other autoimmune diseases were included in this cross sectional analysis to study the impact of SLE on aPL-positive patients. Baseline clinical characteristics were compared using χ 2 or t-tests accordingly. Results As of June 2015, 573 aPL-positive patients recruited from 24 centers; 130 (22.7%) were excluded due to other or overlapping autoimmune diseases, SLE-like disease (fulfilling 3/11 ACR SLE Classification Criteria), or missing data. The mean ages (± SD) of individuals with persistently positive aPL but without other autoimmune diseases (“aPL only”) (female: 218, 73%), and of those with SLE (“aPL with SLE”) (female: 110, 77%) were 44±13 and 49±77, respectively. The majority of patients were Caucasians in both groups (62% and 65%, respectively), followed by Latin Americans (19.3% and 10.5%). Table shows the distribution of the clinical and laboratory characteristics (historically and/or at registry entry). The frequency of criteria and non-criteria APS manifestations was not different between two groups except persistent thrombocytopenia and autoimmune hemolytic anemia, which were more common in the “aPL with SLE” group (14% vs 28% and 2% vs 12%, respectively; both p≤0.001). Nephrotic syndrome, chronic or end-stage renal disease, and hypocomplementemia were also more common in the “apL with SLE” group. Conclusions Concomitant SLE diagnosis in persistently aPL-positive patients is associated with an increased risk of thrombocytopenia, hemolytic anemia, nephrotic syndrome, chronic or end-stage renal disease, and hypocomplementemia; however the risk of other non-criteria manifestations, thrombosis, and pregnancy morbidity remains the same. Acknowledgement APS ACTION Members. Disclosure of Interest None declared

Savino Sciascia - One of the best experts on this subject based on the ideXlab platform.

  • comparison of real world and core laboratory lupus anticoagulant results from the antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository
    Journal of Thrombosis and Haemostasis, 2019
    Co-Authors: M Efthymiou, Danieli Andrade, Doruk Erkan, I Mackie, P J Lane, Rohan Willis, Savino Sciascia, Steven Krillis, E Bison, Margarete B G Vendramini
    Abstract:

    BACKGROUND: Variability remains a challenge in lupus anticoagulant (LA) testing. OBJECTIVE: To validate LA test performance between Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Core laboratories and examine agreement in LA status between Core and local/hospital laboratories contributing patients to this prospective registry. METHODS: Five Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Non-anticoagulated registry samples were retested at the corresponding regional Core laboratories and anticoagulated samples at a single Core laboratory. Categorical agreement and discrepancies in LA status between Core and local/hospital laboratories were analyzed. RESULTS: Clotting times for the reference/characterized plasmas used for normalized ratios were similar between Core laboratories (CV <4%); precision and agreement for LA positive/negative plasma were similar (all CV ≤5%) in the four laboratories that completed both parts of the validation exercise; 418 registry samples underwent LA testing. Agreement for LA positive/negative status between Core and local/hospital laboratories was observed in 87% (115/132) non-anticoagulated and 77% (183/237) anticoagulated samples. However, 28.7% (120/418) of samples showed discordance between the Core and local/hospital laboratories or equivocal LA results. Some of the results of the local/hospital laboratories might have been unreliable in 24.7% (41/166) and 23% (58/252) of the total non-anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance. CONCLUSIONS: Laboratories can achieve good agreement in LA performance by use of the same reagents, analyzer type, and protocols. The standardized Core laboratory results underpin accurate interpretation of APS ACTION clinical data.

  • 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
    Thrombosis Research, 2019
    Co-Authors: Savino Sciascia, Danieli Andrade, Rohan Willis, Maria G Tektonidou, Vittorio Pengo, Amaia Ugarte, Steven A Krilis, Cecilia Beatrice Chighizola, Ware D Branch, Roger A Levy
    Abstract:

    Abstract Background 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.

  • factors associated with first thrombosis in patients presenting with obstetric antiphospholipid syndrome aps in the aps alliance for clinical trials and International Networking clinical database and repository a retrospective study
    British Journal of Obstetrics and Gynaecology, 2018
    Co-Authors: G R De Jesus, Medha Barbhaiya, Danieli Andrade, Savino Sciascia, Maria G Tektonidou, Alessandra Banzato, Vittorio Pengo, L Ji, P L Meroni, Amaia Ugarte
    Abstract:

    OBJECTIVE To evaluate the subsequent rate of thrombosis among women with obstetric antiphospholipid syndrome (Ob-APS) in a multicentre database of antiphospholipid antibody (aPL)-positive patients, and the clinical utility of the adjusted Global Antiphospholipid Syndrome Score (aGAPSS), a validated tool to assess the likelihood of developing new thrombosis, in this group of patients. DESIGN Retrospective study. SETTING The Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking Clinical Database and Repository. POPULATION Women with Ob-APS. METHODS Comparison of clinical and laboratory characteristics and measurement of aGAPSS in women with Ob-APS, with or without thrombosis, after initial pregnancy morbidity (PM). MAIN OUTCOME MEASURES Risk factors for thrombosis and aGAPSS. RESULTS Of 550 patients, 126 had Ob-APS; 74/126 (59%) presented with thrombosis, and 47 (63%) of these women developed thrombosis after initial PM, in a mean time of 7.6 ± 8.2 years (4.9/100 patient years). Younger age at diagnosis of Ob-APS, additional cardiovascular risk factors, superficial vein thrombosis, heart valve disease, and multiple aPL positivity increased the risk of first thrombosis after PM. Women with thrombosis after PM had a higher aGAPSS compared with women with Ob-APS alone [median 11.5 (4-16) versus 9 (4-13); P = 0.0089]. CONCLUSION Based on a retrospective analysis of our multicentre aPL database, 63% of women with Ob-APS developed thrombosis after initial obstetric morbidity; additional thrombosis risk factors, selected clinical manifestations, and high-risk aPL profile increased the risk. Women with subsequent thrombosis after Ob-APS had a higher aGAPSS at entry to the registry. We believe that aGAPSS is a valid tool to improve risk stratification in aPL-positive women. TWEETABLE ABSTRACT More than 60% of women with obstetric antiphospholipid syndrome had thrombosis after initial pregnancy morbidity.

Rohan Willis - One of the best experts on this subject based on the ideXlab platform.

  • comparison of real world and core laboratory lupus anticoagulant results from the antiphospholipid syndrome alliance for clinical trials and International Networking aps action clinical database and repository
    Journal of Thrombosis and Haemostasis, 2019
    Co-Authors: M Efthymiou, Danieli Andrade, Doruk Erkan, I Mackie, P J Lane, Rohan Willis, Savino Sciascia, Steven Krillis, E Bison, Margarete B G Vendramini
    Abstract:

    BACKGROUND: Variability remains a challenge in lupus anticoagulant (LA) testing. OBJECTIVE: To validate LA test performance between Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Core laboratories and examine agreement in LA status between Core and local/hospital laboratories contributing patients to this prospective registry. METHODS: Five Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Non-anticoagulated registry samples were retested at the corresponding regional Core laboratories and anticoagulated samples at a single Core laboratory. Categorical agreement and discrepancies in LA status between Core and local/hospital laboratories were analyzed. RESULTS: Clotting times for the reference/characterized plasmas used for normalized ratios were similar between Core laboratories (CV <4%); precision and agreement for LA positive/negative plasma were similar (all CV ≤5%) in the four laboratories that completed both parts of the validation exercise; 418 registry samples underwent LA testing. Agreement for LA positive/negative status between Core and local/hospital laboratories was observed in 87% (115/132) non-anticoagulated and 77% (183/237) anticoagulated samples. However, 28.7% (120/418) of samples showed discordance between the Core and local/hospital laboratories or equivocal LA results. Some of the results of the local/hospital laboratories might have been unreliable in 24.7% (41/166) and 23% (58/252) of the total non-anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance. CONCLUSIONS: Laboratories can achieve good agreement in LA performance by use of the same reagents, analyzer type, and protocols. The standardized Core laboratory results underpin accurate interpretation of APS ACTION clinical data.

  • 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
    Thrombosis Research, 2019
    Co-Authors: Savino Sciascia, Danieli Andrade, Rohan Willis, Maria G Tektonidou, Vittorio Pengo, Amaia Ugarte, Steven A Krilis, Cecilia Beatrice Chighizola, Ware D Branch, Roger A Levy
    Abstract:

    Abstract Background 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.

  • ab1071 antiphospholipid syndrome alliance for clinical trials and International Networking aps action core laboratory validation exercise comparison of chemiluminescence immunoassay cia and enzyme linked immunosorbant assay elisa
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Maria Laura Bertolaccini, Danieli Andrade, Rohan Willis, Alessandra Banzato, Vittorio Pengo, Gabriella Lakos, Steven A Krilis, Doruk Erkan
    Abstract:

    Background APS ACTION International Clinical Database and Repository was created to study the natural course of disease over 10 years in persistently aPL-positive patients with/without other systemic autoimmune diseases. The protocol involves testing for anticardiolipin antibodies (aCL) and anti-β2glycoprotein I antibodies (aβ2GPI) at five different International core laboratories in samples collected at multiple sites. Although all core laboratories use the same ELISA kits, APS ACTION core laboratory directors agreed that an exchange of samples to assess intra- and inter-laboratory variability is crucial to establish whether an acceptable agreement among the core labs can be achieved. As part of the this validation exercise, two different assays were used. Objectives To assess between-laboratory agreement obtained with a novel antiphospholipid (aPL) chemiluminescence immunoassay (CIA), and compare the results to those obtained with ELISA assays. Methods Blinded serum samples from aPL positive patients and controls (n=30) were distributed to the five APS ACTION core laboratories. All samples were tested for IgG, IgM and IgA aCL and aβ2GPI with the FDA cleared QUANTA Flash® CIA and QUANTA Lite® ELISA kits (Inova Diagnostics). For every sample, the average, SD and %CV of the values were calculated. Between laboratory precision was considered acceptable if %CV was less than 20%. Results Categorical agreement between the two methods was 100%, 97% and 77% for IgG, IgM and IgA aCL, respectively, and 87%, 93% and 77% for IgG, IgM and IgA ab2GPI, respectively. The correlation between quantitative results was good (Spearman rho 0.917, 0.809 and 0.893 for IgG, IgM and IgA aCL, respectively; rho 0.938, 0.766 and 0.78 for IgG, IgM and IgA anti-b2GPI. All p values Conclusions IgG and IgM aCL and aβ2GPI results showed good agreement between CIA and ELISA. Agreement was lower for IgA assays due to borderline samples being positive for CIA (a very sensitive test) and negative for the ELISA. Based on the evaluations performed in the APS ACTION Core Laboratories, CIA and ELISA tests displayed substantially equivalent performance for the detection of aCL and aβ2GPI. QUANTA Flash® CIA, a fully automated assay, however, showed higher level of reproducibility, making inter-laboratory comparisons more reliable. Disclosure of Interest M. L. Bertolaccini: None declared, R. Willis: None declared, G. Lakos Employee of: Inova Diagnostics Inc, D. Andrade: None declared, V. Pengo: None declared, A. Banzato: None declared, S. Krilis: None declared, D. Erkan: None declared