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
| Autor: | Maria Efthymiou, Maria G Tektonidou, Vittorio Pengo, Cecilia Beatrice Chighizola, Esther Rodriguez, Iana Sousa Nascimento, Rohan Willis, Cecilia Nalli, Tatsuya Atsumi, I Mackie, Savino Sciascia, Doruk Erkan, Paul R. Fortin, Renata Lopes Rosa, Hannah Cohen, Maria Laura Bertolaccini, Danieli Andrade, Steve Krilis, D. Ware Branch, Alessandra Banzato, Roger A. Levy, Ignasi Rodríguez-Pintó, Michelle Petri, Aps Action, Amaia Ugarte |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Demographics Databases Factual Enzyme-Linked Immunosorbent Assay Anticardiolipin 030204 cardiovascular system & hematology computer.software_genre Anti-β 2 -glycoprotein I Anti-β 2 glycoprotein I Antiphospholipid antibodies antiphospholipid syndrome miscarriages reproducibility Thrombosis 03 medical and health sciences 0302 clinical medicine immune system diseases Antiphospholipid syndrome Medicine Humans Categorical variable Database biology business.industry Hematology medicine.disease Clinical trial 030220 oncology & carcinogenesis biology.protein Antibodies Antiphospholipid Anticardiolipin antibodies Female Core laboratory Antibody business computer Kappa |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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