International Multicenter, Multiplatform Study to Validate Taipan Snake Venom Time as a Lupus Anticoagulant Screening Test with Ecarin Time as the Confirmatory Test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies
Open accessAbstract
Background Lupus anticoagulant (LA) assays are compromised in anticoagulated patients, and existing strategies to overcome the interferences have limitations. The prothrombin-activating Taipan snake venom time (TSVT) screening test and ecarin time (ET) confirmatory test are innately insensitive to vitamin K antagonists (VKA) and direct factor Xa inhibitors (DFXaI). Objectives Validate standardized TSVT/ET reagents for LA detection, in a multicenter, multiplatform study. Patients/methods Six centers from four countries analyzed samples with TSVT/ET from 81 nonanticoagulated patients with LA, patients with established antiphospholipid syndrome (APS), and proven persistent LA who were either not anticoagulated (n = 120) or were anticoagulated with VKAs (n = 180) or DFXaIs (n = 71). Additionally, 339 nonanticoagulated LA-negative patients, and 575 anticoagulated non-APS patients (172 VKA, 403 DFXaI) were tested. Anticoagulant spiking experiments were performed and 112 samples containing potential interferences (i.e., direct thrombin inhibitors) were tested. Results were evaluated against locally derived cutoffs. Imprecision was evaluated. Results Cutoffs were remarkably similar despite use of different analyzers and donor populations. Cutoffs for TSVT ratio, ET ratio, percent correction, and normalized TSVT ratio/ET ratio ranged between 1.08 and 1.10, 1.09 and 1.12, 9.3% and 14.8%, and 1.10 and 1.15, respectively. Coefficients of variation for TSVT and ET ratios were ≤5.0%. TSVT/ET exhibited sensitivity, specificity, and negative and positive predictive values of 78.2%/95.0%/86.3%/91.5%, respectively, with established APS as the LA-positive population, and 86.9%/95.0%/76.8%/97.4%, respectively, with triple-positive APS. Interference was seen with direct thrombin inhibitors, unfractionated heparin, and low molecular weight heparins, but not VKAs or DFXaIs. Conclusions TSVT/ET are validated for LA detection in nonanticoagulated patients and those on VKAs or DFXaIs.
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The combination of TSVT/ET demonstrated good sensitivity and specificity in LA detection in VKA-treated patients in an international multicenter multiplatform study, but is not routinely utilized in laboratories at present.
“the use of the combination of TSVT/ET (Taipan snake venom time/ecarin time), which in an international multicenter multiplatform study demonstrated good sensitivity and specificity in LA detection in VKA-treated patients [28], but is not routinely utilized in laboratories at present”
From Lupus Anticoagulant Detection under the Magnifying Glass (2023) · cites this paper as [28]
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- Authors
- Moore, G. W., Jones, P. O., Platton, S., Hussain, N., White, D., Thomas, W., Rigano, J., Pouplard, C., Gray, E., & Devreese, K. M. J.
- Affiliations
- St Thomas' Hospital (GB)
- Barts Health NHS Trust (GB)
- Cambridge University Hospitals NHS Foundation Trust (GB)
- The Alfred Hospital (AU)
- Université de Tours (FR)
- National Institute for Biological Standards and Control (GB)
- Ghent University Hospital (BE)
- Corresponding author
- Moore, Gary W.
- ORCID
- Venue
- Journal of Thrombosis and Haemostasis
- Publisher
- Elsevier BV
- Published
- 2021-12
- Volume
- 19
- Issue
- 12
- Pages
- 3177-3192
- ISSN
- 1538-7836 (ISSN-L)
- OpenAlex
- W3176076200
- Cited by
- 47
- References
- 76
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 13 · 2023: 10 · 2022: 7 · 2021: 2
- FWCI
- 5.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Middlesex University Research Repository (Middlesex University Of London) (acceptedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- lupus anticoagulant, antiphospholipid syndrome, anticoagulant interference, vitamin K antagonists, direct factor Xa inhibitors, direct thrombin inhibitors, assay validation, cut-off values, anticoagulated patients, antiphospholipid antibodies, assay precision and accuracy
- MeSH terms
- Communication, Heparin, Humans, Endopeptidases, Prothrombin Time, Snake Venoms, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome
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