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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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In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measured
The cited source says what the claim attributes to it.
In the citing paper
“Guidelines recommend mixing tests are interpreted with either a mixing test specific cut‐off (MTC) or the index of circulating anticoagulant (ICA).”
The cited source says what the claim attributes to it.
In the citing paper
“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”
The cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“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]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“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]
Experimental — accuracy not yet measured
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“Mixing patient plasma with NPP can correct these factor deficiencies, especially if patient INR (international normalized ratio) is 3.0 [8]: for this reason, CLSI, BSH, and past (2009) ISTH guidelines [15,33,36] consider the possibility of 1:1 mixing with NPP before testing.”
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Metadata
- 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 › Hematology › 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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