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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
Author(s) -
Efthymiou Maria,
Mackie Ian J.,
Lane Philip J.,
Andrade Danieli,
Willis Rohan,
Erkan Doruk,
Sciascia Savino,
Krillis Steven,
Bison Elisa,
Borges Galhardo Vendramini Margarete,
RomayPenabad Zurina,
Qi Miao,
Tektonidou Maria,
Ugarte Amaia,
Chighizola Cecilia,
Belmont H. Michael,
Aguirre Maria Angeles,
Ji Lanlan,
Branch D. Ware,
Jesus Guilherme,
Fortin Paul R.,
Andreoli Laura,
Petri Michelle,
Cervera Ricard,
Rodriguez Esther,
Knight Jason S.,
Atsumi Tatsuya,
Vega Joann,
Sevim Ecem,
Bertolaccini Maria Laura,
Pengo Vittorio,
Cohen Hannah
Publication year - 2019
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.14596
Subject(s) - medicine , lupus anticoagulant , clinical trial , antiphospholipid syndrome , core (optical fiber) , medical physics , thrombosis , materials science , composite material
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.