Guidelines on the investigation and management of antiphospholipid syndrome

Keeling, David; Mackie, Ian; Moore, Gary W.; Greer, Ian A.; Greaves, Michael; British Committee for Standards in Haematology

doi:10.1111/j.1365-2141.2012.09037.x

Cited by 740Systemic Lupus Erythematosus ResearchVasculitis and related conditionsBlood Coagulation and Thrombosis Mechanisms

Guidelines on the investigation and management of antiphospholipid syndrome

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Keeling, David, Mackie, Ian, Moore, Gary W., Greer, Ian A., Greaves, Michael, British Committee for Standards in Haematology·2012·British Journal of Haematology

DOI 10.1111/j.1365-2141.2012.09037.x

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Abstract

The British Journal of Haematology publishes original research papers in clinical, laboratory and experimental haematology. The Journal also features annotations, reviews, short reports, images in haematology and Letters to the Editor.

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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).”
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 [7]
The Lupus anticoagulant testing section says mixing tests may be used to detect an inhibitor, and the Recommendation section describes interpreting an abnormal screening result from a mixture. Neither passage recommends interpreting mixing tests with an MTC or ICA; the paper’s discussion of cut-offs concerns LA tests generally, not those two methods specifically. Page numbers are unavailable in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Integrated 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 [7]
The Lupus anticoagulant testing section says that, when no other cause of prolonged clotting time is present, samples may be considered LA-positive based on positive screening and confirmatory tests on undiluted plasma, despite a negative mixing test. It does not specify that the confirmatory test result must fall within its reference interval, and it recommends confirmation with a fresh sample whenever possible. Page numbers are unavailable in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measured
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 [12]
The ‘Lupus anticoagulant testing’ section recommends percentage correction or a normalized screen-to-confirm ratio for interpreting LA tests. It does not recommend an unnormalized screen-to-confirm ratio (SCR) as a separate index; it specifies that screen and confirm results should first be expressed as ratios against a normal plasma pool. No page number is available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measured
CLSI and BSH guidelines employ a "parametric" approach assuming a Gaussian distribution of LA results, using a reference range of ±2 standard deviations from the mean value.
“CLSI and BSH guidelines [15,36], on the other hand, employ a “parametric” approach assuming a Gaussian distribution of LA results, using a reference range of ±2 standard deviations from the mean value”
From Lupus Anticoagulant Detection under the Magnifying Glass (2023) · cites this paper as [36]
The Lupus anticoagulant testing section says laboratories have historically used mean + 2 SD as an LA-positive cutoff for normally distributed data, and that most UK laboratories use the corresponding 97.5th centile. It does not prescribe a ±2 SD reference range or say that LA results must be Gaussian; it also notes a contrasting 99th-centile recommendation. This source does not establish what the separately cited CLSI guideline uses. (LLM, conf=0.87)
Experimental — accuracy not yet measured
Clotting times of screening, mixing, and confirmatory procedures are prone to inter- and intra-assay variability; therefore, it is recommended to normalize these clotting times by generating a ratio between test clotting time and NPP clotting time.
“Clotting times of screening, mixing, and confirmatory procedures are prone to inter- (between same-principle tests offered by different manufacturers) and intra-assay (between batches of the same reagent) variability [25]; for this reason, it is recommended to normalize a screening, mixing, and confirmatory clotting time, generating a ratio between test clotting time and NPP clotting time [9,36,48”
From Lupus Anticoagulant Detection under the Magnifying Glass (2023) · cites this paper as [36]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured

British Society for Haematology and Clinical and Laboratory Standards Institute guidelines have also helped increase uniformity.
“Equally, the British Society for Haematology 13 and the Clinical and Laboratory Standards Institute (CLSI) guidelines 14 have contributed to increased uniformity.”
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 [13]
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”
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 [7]
Mixing tests may make weak LA samples appear negative due to a dilution factor.
“mixing plasma with NPP shows a dilution factor that can make weaker LA samples appear negative in the mixing test despite clear positivity in the screening and confirmation results on undiluted plasma”
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 [7]
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 [12]
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 [12]
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 [12]
Each laboratory employed guideline compliant plasma preparation and storage procedures, and dRVVT and APTT assay performance and interpretation.
“Each laboratory employed guideline compliant plasma preparation and storage procedures, and dRVVT and APTT assay performance and interpretation [17][18][19].”
From Triple-positive antiphospholipid syndrome does not guarantee positivity in each lupus anticoagulant assay (2023) · cites this paper as [17]

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LUPUS ANTICOAGULANT AND RECURRENT FETAL LOSS: SUCCESSFUL TREATMENT WITH GAMMAGLOBULIN
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Clinical significance of different antiphospholipid antibodies in the WAPS (warfarin in the antiphospholipid syndrome) study
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A Clinical Trial for the Treatment of Antiphospholipid Antibody‐Associated Recurrent Pregnancy Loss With Lower Dose Heparin and Aspirin
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Induction of endothelial cell tissue factor activity by sera from patients with antiphospholipid syndrome: A possible mechanism of thrombosis
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Inhibition of the thrombogenic and inflammatory properties of antiphospholipid antibodies by fluvastatin in an in vivo animal model
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The lupus anticoagulant
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Treatment of Antiphospholipid Antibody Syndrome (APS) in Pregnancy: A Randomized Pilot Trial Comparing Low Molecular Weight Heparin to Unfractionated Heparin
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Fluvastatin inhibits up‐regulation of tissue factor expression by antiphospholipid antibodies on endothelial cells
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Point‐of‐care testing in haemostasis
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Migraine, memory loss, and “multiple sclerosis ”. Neurological features of the antiphospholipid (Hughes’) syndrome
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A Retrospective Review of 61 Patients With Antiphospholipid Syndrome: Analysis of Factors Influencing Recurrent Thrombosis
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“…and observational studies it was thought that stroke associated with aPL carried a high risk of recurrence (with the likelihood of consequent permanent disability or death) and should be treated with long-term warfarin (Rosove & Brewer, 1992; Khamashta et al, 1995; Krnic-Barrie et al, 1997).”
BackgroundMethodInfluential
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Comparison between single antiplatelet therapy and combination of antiplatelet and anticoagulation therapy for secondary prevention in ischemic stroke patients with antiphospholipid syndrome
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Antibodies to β2-glycoprotein I—a specific marker for the antiphospholipid syndrome
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Authors: Keeling, D., Mackie, I., Moore, G. W., Greer, I. A., Greaves, M., & British Committee for Standards in Haematology
Affiliations: Churchill Hospital (GB)
University College London (GB)
St Thomas' Hospital (GB)
University of Liverpool (GB)
University of Aberdeen (GB)
Corresponding author: Keeling, David
ORCID: Keeling, David
Mackie, Ian
Moore, Gary W.
Venue: British Journal of Haematology
Publisher: Wiley
Published: 2012-02-08
Volume: 157
Issue: 1
Pages: 47-58
ISSN: 0007-1048 (ISSN-L)
1365-2141
DOI: 10.1111/j.1365-2141.2012.09037.x
OpenAlex: W2160597832
Cited by: 740
References: 176
Citations by year: 2026: 6 · 2025: 14 · 2024: 30 · 2023: 29 · 2022: 38 · 2021: 44 · 2020: 47 · 2019: 51 · 2018: 38 · 2017: 44 · 2016: 45 · 2015: 44 · 2014: 41 · 2013: 26 · 2012: 14
FWCI: 30.38
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: British Journal of Haematology (publishedVersion)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords: antiphospholipid syndrome, antiphospholipid antibodies, thrombosis, pregnancy complications, clinical management, diagnostic workup
MeSH terms: Humans, Antiphospholipid Syndrome

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