Update of the guidelines for lupus anticoagulant detection
Open accessAbstract
One of the conclusions of the subcommittee meeting on Lupus Anticoagulant/Phospholipid dependent antibodies, held in Geneva on 2007, was the need to update the guidelines on Lupus Anticoagulant (LA) detection. Particular emphasis was given to several aspects discussed in this official communication. A new paragraph is dedicated to the patient selection, and aims to minimize inappropriate requests for LA testing. Modalities for blood collection and processing are fully delineated and the choice of tests is limited to dRVVT and a sensitive aPTT. Calculation of cut-off values for each diagnostic step are clearly stated. A final paragraph reports the interpretation of the results in general and in particular situations.
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Hydroxychloroquine use was associated with lower odds of persistently positive lupus anticoagulant and/or moderate-to-high Sapporo criteria antiphospholipid antibodies, with an odds ratio of 0.24 (95% CI 0.06-0.94), p=0.04.
“Similarly, persistently positive LAC and/or moderate/high Sapporo criteria aPL Abs (aCL IgG or IGM, or anti-b2GPI IgG or IgM) (10) were associated with HCQ use, OR 0.24 (0.06, 0.94), p=0.04”
From Hydroxychloroquine Use Is Associated with Lower Odds of Persistently Positive Antiphospholipid Antibodies and/or Lupus Anticoagulant in Systemic Lupus Erythematosus (2013) · cites this paper as [10]
The citation follows the description of persistently positive LAC and Sapporo-criteria antibodies. In Patient selection (page unavailable), the guideline says a positive lupus anticoagulant result must be repeated more than 12 weeks later, supporting the persistence requirement. Our copy does not establish the stated moderate-to-high antibody criteria or report an association with hydroxychloroquine, the odds ratio, or its p-value. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe 2009 ISTH-SSC guidelines for LA detection have been useful in increasing uniformity in how LA testing is performed and interpreted.
“The last update of the guidelines for LA detection by the International Society on Thrombosis and Haemostasis Scientific and Standardization Subcommittee (ISTH-SSC) in 2009 12 has proven useful in achieving greater uniformity in performance and interpretation of LA testing.”
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 [12]
The Abstract identifies this as the 2009 update and specifies procedures for LA testing and interpretation. Its statement that guidelines had been useful over the preceding 13 years refers to the earlier criteria, not demonstrated effects of the 2009 update. The paper does not establish that the update had already increased uniformity. (LLM, conf=0.84)
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”
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 [12]
The Patient selection section (page unavailable) reports variability in laboratory performance and says cut-off values and expression of results affect LA testing. The Integrated tests section (page unavailable) says interpreting results in patients taking vitamin K antagonists is difficult. These passages support difficulties with the named testing issues, but the paper does not report survey responses showing uncertainty or lack of agreement on them. (LLM, conf=0.77)
Experimental — accuracy not yet measuredIntegrated testing is sufficient to detect LA without performing the mixing test in samples with no other causes of clotting time prolongation and LA confirmatory test results within reference intervals.
“For samples from patients with no other causes of clotting time prolongation and LA assay confirmatory test results within reference intervals, the increasingly popular paradigm of integrated testing is sufficient to detect the presence of LA without performing the mixing test at all.6, 7, 8, 9, 26, 27, 28, 31, 33, 34”
From Lupus anticoagulant mixing tests for multiple reagents are more sensitive if interpreted with a mixing test‐specific cut‐off than index of circulating anticoagulant (2018) · cites this paper as [6]
The Integrated tests section says these tests combine screening and confirmation and, in principle, do not require a mixing test. It does not establish that they are sufficient specifically when other causes of prolonged clotting time are absent and confirmatory results fall within reference intervals. Its statement is also more qualified than the citing sentence’s assertion of sufficiency. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe mixing test is mainly to discriminate between the presence of an inhibitor and coagulation factor deficiencies such as those occurring in patients on VKA.
“The mixing test is mainly to discriminate between the presence of an inhibitor and coagulation factor deficiencies such as those occurring in patients on conventional oral anticoagulants/vitamin K antagonists (VKA).”
From Mixing studies in lupus anticoagulant testing are required at least in some type of samples (2015) · cites this paper as [1]
The Mixing test section (page unavailable) specifies normal plasma with approximately 100% activity of all clotting factors and notes that inhibitors can prolong a mixing test. The section on LA detection in patients taking VKA (page unavailable) discusses prolonged clotting times and possible mixing with normal plasma. Our copy does not explicitly say that the mixing test is mainly used to distinguish inhibitors from factor deficiencies, or identify VKA-related factor deficiencies as that comparison. (LLM, conf=0.79)
Experimental — accuracy not yet measured
Guidelines recommend that mixing tests are interpreted with either MTC or ICA.
“Guidelines recommend mixing tests are interpreted with either a mixing test specific cut‐off (MTC) or the index of circulating anticoagulant (ICA).”
There is no single test to detect all LA, and guidelines recommend performance of two different tests (dRVVT and LA-sensitive APTT).
“There is no single test to detect all LA1, 6, 7, 8 and guidelines recommend performance of two different tests that represent different assay principles, the diluted Russell's viper venom time (dRVVT) and a LA‐sensitive activated partial thromboplastin time (APTT).6, 7, 8”
LA positivity was determined following SSC/ISTH recommendations at the time of testing.
“LA positivity was determined following the Scientific and Standardization Committee (SSC)/International Society on Thrombosis and Hemostasis (ISTH) recommendations at the time of testing.11,13”
From Lupus anticoagulant test persistence over time and its associations with future thrombotic events (2022) · cites this paper as [13]
The lupus anticoagulant assay followed international guidelines.
“The lupus anticoagulant assay (LA) followed international guidelines for the performance of this functional assay (54).”
From Autoantibodies in Systemic Lupus Erythematosus Target Mitochondrial RNA (2019) · cites this paper as [54]
According to ISTH/SSC and CLSI guidelines, LAC identification should include three steps: screening, mixing, and confirmation.
“According to ISTH/SSC (1) and CLSI (2) guidelines LAC identification should include three steps: screening for prolongation in a phospholipid-sensitive test, mixing with normal plasma to identify failure to correct and confirmation through result shortening in a phospholipid-rich test, (though in slightly different priority with CLSI).”
From Mixing studies in lupus anticoagulant testing are required at least in some type of samples (2015) · cites this paper as [1]
Results were interpreted according to in-house calculated cut-off values calculated with the 99th percentile.
“Results were expressed as normalized ratios and interpreted according to in-house calculated cut-off values calculated with the 99th percentile (1).”
From Mixing studies in lupus anticoagulant testing are required at least in some type of samples (2015) · cites this paper as [1]
Testing patients during VKA or other anticoagulant therapy for LAC remains a contentious issue and has been discouraged by official guidelines because of interpretational problems affecting the mixing test.
“Testing patients during VKA or other anticoagulant therapy for LAC remains a contentious issue and has been discouraged by official guidelines (1, 2) because of interpretational problems affecting the mixing test (8-10).”
From Mixing studies in lupus anticoagulant testing are required at least in some type of samples (2015) · cites this paper as [1]
Because no single assay is sensitive to all LA antibodies, at least 2 coagulation tests based on different assay principles are recommended for LA detection.
“Because there is no single assay sensitive to all LA antibodies, at least 2 coagulation tests based on different assay principles are recommended for LA detection [[11], [12], [13]].”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [11]
Various interpretation indices, including %Correct, SCR, and NSCR, are suggested to determine the presence of LA in phospholipid-dependent assays.
“Various interpretation indices, including percentage of correction (%Correct), screen-to-confirm ratio (SCR), and normalized SCR (NSCR), are suggested to determine the presence of LA in these phospholipid-dependent assays [[11], [12], [13]].”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [11]
LA detection laboratory tests comprise complex and multistep coagulation testing procedures, including screening, confirmatory, and mixing tests.
“Laboratory tests for LA detection comprise complex and multistep coagulation testing procedures, including screening, confirmatory, and mixing tests [[11], [12], [13]], and heterogeneity in these is an important cause of interlaboratory variation.”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [11]
The LA-sensitive aPTT assay can be used as a secondary test for LA detection.
“The diluted Russell’s viper venom time (dRVVT) assay is the first recommended test for detecting LA due to its high sensitivity and specificity [14], while the LA-sensitive activated partial thromboplastin time (aPTT) assay can be used as a secondary test [[11], [12], [13], [14]].”
From Comparison of different algorithms for lupus anticoagulant detection: a single-center experience (2024) · cites this paper as [11]
LAC was determined according to ISTH guidelines using dRVVT and aPTT.
“LAC was determined using the STA-R Evolution Coagulation Analyzer (Diagnostica Stago, Asnières-sur-Seine, France) according to ISTH guidelines 1 applying dilute Russell ' s viper venomtime (dRVVT Screen and dRVVT Confirm, Diagnostica Stago, Asnières-sur-Seine, France) and a sensitive activated partial thromboplastin time (aPTT) with silica as an activator (PTT-LA, Diagnostica Stago, Asnières-sur-”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [1]
This study supports the dRVVT as the preferred assay to detect LAC.
“This study supports the dRVVT as the preferred assay to detect LAC. 1”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [1]
LAC was performed according to the ISTH guidelines.
“and LAC was performed according to the ISTH guidelines. 1,34”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [1]
LA was determined using two clotting assays as recommended by the 2009 ISTH guidelines.
“LA was determined using two clotting assays as recommended by the 2009 International Society on Thrombosis and Haemostasis (ISTH) guidelines, 21 which were applicable at the time of the study: APTT by Diagnostica Stago and dRVVT by HYPHEN BioMed. 21”
From Single or triple positivity for antiphospholipid antibodies in “carriers” or symptomatic patients: Untangling the knot (2021) · cites this paper as [21]
The samples were analyzed before publication of the new guidelines and interpreted according to the guidelines applicable at that time.
“However, the samples were analyzed before the publication of these new guidelines and therefore interpreted according to the guidelines that were applicable at this time. 21”
From Single or triple positivity for antiphospholipid antibodies in “carriers” or symptomatic patients: Untangling the knot (2021) · cites this paper as [21]
Most survey participants indicated that pooled normal plasma should be constituted from at least 40 donors.
“The majority of survey participants indicated that the number should be at least 40, which seems reasonable to guarantee an overall normal clotting factor activity. 12”
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 [12]
The Mixing test section says pooled normal plasma should have approximately 100% activity for all clotting factors, but gives no donor count or survey response. The Integrated tests section specifies at least 40 healthy donors for establishing local test cut-offs, not for constituting pooled normal plasma. A search for the survey majority and the proposed PNP donor count found no passage addressing either point; page numbers were unavailable in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- PENGO, V., TRIPODI, A., REBER, G., RAND, J. H., ORTEL, T. L., GALLI, M., & DE GROOT, P. G.
- Affiliations
- University of Padua (IT)
- University of Milan (IT)
- University Hospital of Geneva (CH)
- Montefiore Medical Center (US)
- Duke Medical Center (US)
- Corresponding author
- PENGO, V.
- Venue
- Journal of Thrombosis and Haemostasis
- Publisher
- Elsevier BV
- Published
- 2009-10
- Volume
- 7
- Issue
- 10
- Pages
- 1737-1740
- ISSN
- 1538-7836 (ISSN-L)
- OpenAlex
- W2069797332
- Cited by
- 1,197
- References
- 21
- Citations by year
- 2026: 20 · 2025: 32 · 2024: 53 · 2023: 55 · 2022: 65 · 2021: 89 · 2020: 99 · 2019: 101 · 2018: 88 · 2017: 82 · 2016: 80 · 2015: 75 · 2014: 81 · 2013: 69 · 2012: 82
- FWCI
- 48.25
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Surgery › Heparin-Induced Thrombocytopenia and Thrombosis
- Keywords
- lupus anticoagulant, patient selection, activated partial thromboplastin time, cut-off values, interpretation of results, diagnostic guidelines
- MeSH terms
- Anticoagulants, Blood Coagulation, Blood Specimen Collection, Female, Humans, Indicators and Reagents, Male, Partial Thromboplastin Time, Phospholipids, Pregnancy, Pregnancy Complications, Hematologic, Prothrombin Time, Specimen Handling, Vitamin K, Artifacts, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome, Patient Selection
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