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Comparison of Real World and Core Laboratory Lupus Anticoagulant Results from the Antiphospholipid Syndrome (APS) ACTION Clinical Database and Repository

Efthymiou, M; Mackie, IJ; Lane, PJ; Andrade, D; Willis, R; Erkan, D; Sciascia, S; ... APS ACTION, .; + view all (2019) Comparison of Real World and Core Laboratory Lupus Anticoagulant Results from the Antiphospholipid Syndrome (APS) ACTION Clinical Database and Repository. Journal of Thrombosis and Haemostasis 10.1111/jth.14596. (In press).

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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 analyser, protocol, and characterised 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 analysed. // RESULTS: Clotting times for the reference/ characterised plasmas used for normalised 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 same reagents, analyser type, and protocols. The standardised Core laboratory results underpin accurate interpretation of APS ACTION clinical data.

Type: Article
Title: Comparison of Real World and Core Laboratory Lupus Anticoagulant Results from the Antiphospholipid Syndrome (APS) ACTION Clinical Database and Repository
DOI: 10.1111/jth.14596
Publisher version: https://doi.org/10.1111/jth.14596
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Russells viper venom time (RVVT), antiphospholipid antibodies, antiphospholipid syndrome, lupus anticoagulant, thrombosis
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Haematology
URI: http://discovery.ucl.ac.uk/id/eprint/10079345
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