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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
dc.contributor.authorEfthymiou, Maria
dc.contributor.authorMackie, Ian J.
dc.contributor.authorLane, Philip J.
dc.contributor.authorAndrade, Danieli
dc.contributor.authorWillis, Rohan
dc.contributor.authorErkan, Doruk
dc.contributor.authorSciascia, Savino
dc.contributor.authorKrillis, Steven
dc.contributor.authorBison, Elisa
dc.contributor.authorBorges Galhardo Vendramini, Margarete
dc.contributor.authorRomay‐penabad, Zurina
dc.contributor.authorQi, Miao
dc.contributor.authorTektonidou, Maria
dc.contributor.authorUgarte, Amaia
dc.contributor.authorChighizola, Cecilia
dc.contributor.authorBelmont, H. Michael
dc.contributor.authorAguirre, Maria Angeles
dc.contributor.authorJi, Lanlan
dc.contributor.authorBranch, D. Ware
dc.contributor.authorJesus, Guilherme
dc.contributor.authorFortin, Paul R.
dc.contributor.authorAndreoli, Laura
dc.contributor.authorPetri, Michelle
dc.contributor.authorCervera, Ricard
dc.contributor.authorRodriguez, Esther
dc.contributor.authorKnight, Jason S.
dc.contributor.authorAtsumi, Tatsuya
dc.contributor.authorVega, Joann
dc.contributor.authorSevim, Ecem
dc.contributor.authorBertolaccini, Maria Laura
dc.contributor.authorPengo, Vittorio
dc.contributor.authorCohen, Hannah
dc.date.accessioned2020-01-13T15:07:07Z
dc.date.availableWITHHELD_12_MONTHS
dc.date.available2020-01-13T15:07:07Z
dc.date.issued2019-12
dc.identifier.citationEfthymiou, Maria; Mackie, Ian J.; Lane, Philip J.; Andrade, Danieli; Willis, Rohan; Erkan, Doruk; Sciascia, Savino; Krillis, Steven; Bison, Elisa; Borges Galhardo Vendramini, Margarete; Romay‐penabad, 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 (2019). "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 17(12): 2069-2080.
dc.identifier.issn1538-7933
dc.identifier.issn1538-7836
dc.identifier.urihttps://hdl.handle.net/2027.42/152667
dc.description.abstractBackgroundVariability remains a challenge in lupus anticoagulant (LA) testing.ObjectiveTo 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.MethodsFive Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Nonâ 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.ResultsClotting 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 â ¤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) nonâ 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 nonâ anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance.ConclusionsLaboratories 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.
dc.publisherWiley Periodicals, Inc.
dc.publisherClinical and Laboratory Standards Institute
dc.subject.otherthrombosis
dc.subject.otherantiphospholipid antibodies
dc.subject.otherRussell’s viper venom time
dc.subject.otherlupus anticoagulant
dc.subject.otherantiphospholipid syndrome
dc.titleComparison 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
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelInternal Medicine and Specialties
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/152667/1/jth14596.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/152667/2/jth14596_am.pdf
dc.identifier.doi10.1111/jth.14596
dc.identifier.sourceJournal of Thrombosis and Haemostasis
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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