Clinical and laboratory practice for lupus anticoagulant testing: an International Society of Thrombosis and Haemostasis Scientific and Standardization Committee survey
Open accessAbstract
Background Current guidelines have contributed to more uniformity in the performance and interpretation of lupus anticoagulant (LA) testing. However, points to reconsider include testing for LA in patients on anticoagulation, cut-off values, and interpretation of results.Objectives The aim of this International Society of Thrombosis and Haemostasis Scientific and Standardization committee (ISTH SSC) questionnaire was to capture the spectrum of clinical and laboratory practice in LA detection, focusing on variability in practice, so that the responses could inform further ISTH SSC recommendations.Methods Members of the ISTH SSC on Lupus Anticoagulant/Antiphospholipid Antibodies and participants of the Lupus Anticoagulant/Antiphospholipid Antibodies Programme of the External quality Control of diagnostic Assays and Tests Foundation were invited to complete a questionnaire on LA testing that was placed on the ISTH website using RedCap, with data tallied using simple descriptive statistics.Results There was good agreement on several key recommendations in the ISTH and other guidelines on LA testing, such as sample processing, principles of testing, choice of tests, repeat testing to confirm persistent positivity and the use of interpretative reporting. However, the results highlight that there is less agreement on some other aspects, including the timing of testing in relation to thrombosis or pregnancy, testing in patients on anticoagulation, cut-off values, and calculation and interpretation of results.Conclusions Although some of the variability in practice in LA testing reflects the lack of substantive data to underpin evidence-based recommendations, a more uniform approach, based on further guidance, should reduce the inter-center variability of LA testing.
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Sample collection and processing as described in the 2009 ISTH-SSC guidelines is widely applied.
“Sample collection and processing as described in the ISTH-SSC 2009 guidelines is widely applied.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
The Essentials section reports that 86.8% of respondents agreed samples should be collected and processed in line with the 2009 guidelines. That supports broad acceptance of the procedures, but the survey response does not establish that they are widely applied in practice. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe ISTH-SSC survey showed considerable lack of agreement on cutoff calculation: 79% calculated in-house cutoffs, but only 12% used more than 120 normal samples.
“The ISTH-SSC survey showed a considerable lack of agreement on calculation of cutoff values, although 79% stated that they calculate their in-house cutoff values, but only 12% indicated use of >120 normals.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
The 'Number of healthy adult donors for the preparation of in-house' section reports that 78.9% of laboratories calculated in-house cutoffs, and the discussion reports considerable disagreement about cutoffs. The 12% figure applies only to respondents who indicated use of the 99th centile, not to respondents overall; Figure 4B shows 4% selecting >120 donors in its broader question. (LLM, conf=0.89)
Experimental — accuracy not yet measuredMost laboratories calculate normalized ratios by dividing the patient's clotting time by the pooled normal plasma clotting time measured in the same run.
“Normalized ratios calculated by dividing the clotting time of the patient by the clotting time of the PNP measured in the same run, as advised in the 2009 guidelines, is applied by the majority of laboratories.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
In the section on normalized-ratio calculations (page not available), 65.7% of survey respondents said the denominator should be pooled normal plasma analyzed in the same run. That supports the majority and same-run aspects, but the passage reports what respondents said should be done, not that most laboratories actually use this calculation. (LLM, conf=0.82)
Experimental — accuracy not yet measuredAn overwhelming majority of survey participants, 94.5%, supported the combination of APTT and dRVVT.
“is supported by an overwhelming majority of participants (94.5%) of the survey reflecting daily practice.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
In the survey’s LA testing passage (page not specified), 94.5% agreed that testing should include two phospholipid-dependent clotting tests based on different principles. The passage identifies dRVVT and APTT as tests used by many respondents, but does not say that 94.5% specifically supported their combination. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe 99th centile was used by 50% of survey participants.
“The 99th centile, chosen to avoid false positives, was applied by 50% of survey participants.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
The cut-offs results (Figure 4A; page not provided) report that 50% of respondents said the cut-off for screen, mixing, and confirmatory tests should be above the 99th centile. That supports the percentage, but the question asked what the cut-off should be, not whether participants applied it; the paper also does not give avoiding false positives as their reason for choosing it. (LLM, conf=0.86)
Experimental — accuracy not yet measured
In a survey, more than 80% of participants considered a small number (20 or 40) of normal donors reliable for solid phase assays.
“a small number (20 or 40) of normal donors, 68 as often applied for the solid phase assays, 75 and found reliable by more than 80% of the survey participants.15”
From Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis (2020) · cites this paper as [15]
The discussion of cut-off values says 20–40 normal subjects may be used to verify a manufacturer’s cut-off. In the survey results on healthy donors, 81.2% agreed that manufacturer cut-offs for lupus anticoagulant positivity should be locally validated—not that 20 or 40 donors were reliable, and not specifically for solid-phase assays. No page numbers are available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSurvey responses showed uncertainty or lack of agreement on testing in anticoagulated patients, cutoff values, and calculation and interpretation of results.
“However, on other points, including testing in patients on anticoagulation, cutoff values, and calculation and interpretation of results, there was uncertainty or lack of agreement.12,15”
A majority of ISTH-SSC survey respondents, 84.1%, affirmed the need for mixing tests.
“The need for mixing tests is reflected in the affirmative response of majority of the ISTH-SSC survey respondents (84.1%) and recent literature.15,61,62”
Technical and practical issues, including test algorithms, interpretation parameters, cutoff values, and methods of interpretation, are problematic in many laboratories.
“Technical and practical issues, including test algorithms, interpretation parameters, cutoff values, and methods of interpretation, are problematic in many laboratories [6,8,9,21].”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [21]
A recent internationally circulated ISTH SSC questionnaire revealed that 98.9% of respondents used dRVVT and 79.7% used an LA-sensitive APTT for routine LA detection.
“A recent internationally circulated ISTH SSC questionnaire revealed that 98.9% of respondents used dRVVT and 79.7% used an LA-sensitive APTT for routine LA detection [34].”
From Triple-positive antiphospholipid syndrome does not guarantee positivity in each lupus anticoagulant assay (2023) · cites this paper as [34]
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- Authors
- Cohen, H., Mackie, I. J., & Devreese, K. M. J.
- Affiliations
- University College Hospital (GB)
- University College London (GB)
- Ghent University Hospital (BE)
- Corresponding author
- Cohen, Hannah
- Venue
- Journal of Thrombosis and Haemostasis
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 17
- Issue
- 10
- Pages
- 1715-1732
- ISSN
- 1538-7836 (ISSN-L)
- OpenAlex
- W2954422860
- Cited by
- 48
- References
- 42
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 8 · 2023: 11 · 2022: 6 · 2021: 4 · 2020: 9 · 2019: 2
- FWCI
- 3.98
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- UCL Discovery (University College London) (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
- antiphospholipid antibodies, clinical practice variation, anticoagulation, cut-off values, interpretation of results, external quality control, pregnancy, thrombosis, sample processing
- MeSH terms
- Blood Chemical Analysis, Humans, Predictive Value of Tests, Reproducibility of Results, Biomarkers, Observer Variation, Lupus Coagulation Inhibitor, Health Care Surveys, Healthcare Disparities, Clinical Laboratory Services
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