Antiphospholipid antibody testing and standardization

Devreese, K. M. J.

doi:10.1111/ijlh.12234

Cited by 98Systemic Lupus Erythematosus ResearchClinical Laboratory Practices and Quality ControlBlood Coagulation and Thrombosis Mechanisms

Antiphospholipid antibody testing and standardization

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Devreese, K. M. J.·2014·International Journal of Laboratory Hematology

DOI 10.1111/ijlh.12234

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Abstract

The laboratory criteria that define patients with antiphospholipid syndrome (APS) include lupus anticoagulant (LAC), anticardiolipin antibodies and anti-β2 glycoprotein I antibodies (aβ2GPI). All assays show methodological shortcomings and the combination of the three tests, each with different sensitivity and specificity, and hence, differences in clinical utility make the laboratory diagnosis of APS challenging. Consensus guidelines and proposals for antiphospholipid antibodies (aPL) testing have been published in the last 20 years and have led to a substantial improvement. Despite efforts so far, standardization is not reached yet, but progress has been made. On-going efforts to reduce the interlaboratory/interassay variations remain important; even an absolute standardization cannot be feasibly achieved. Taking into account the methodological shortcomings of the means we have available, more detailed guidelines may help in adequate performance of aPL testing. This review will focus on the efforts and achievements in standardization and on the weaknesses and strengths of the current available laboratory methods.

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LA detection relies on phospholipid-dependent coagulation tests, which make the methodology and interpretation difficult because anticoagulant therapy and acute phase proteins can interfere.
“LA detection is based on phospholipid (PL)-dependent coagulation tests, which complicate the methodology and hamper its interpretation because of interference, for instance by anticoagulant therapy and some acute phase response proteins.3,4”
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 [3]
Anticoagulant therapy is a main confounding factor in LA testing because it prolongs clotting times in phospholipid-dependent assays.
“One of the main confounding factors in LA testing is anticoagulant therapy, prolonging the clotting times in the PL-dependent assays used for LA detection.”
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 [3]
Retesting positive after 12 weeks strengthens the initial result and adds confidence, particularly amid poor standardization and interfering factors.
“A confirmatory positive test after 12 weeks renders the initial test result more reliable and increases assurance of a test result in the context of poor standardization and interferences affecting the test result.2,3”
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 [3]
International External Quality Assessment programs have shown significant inter-laboratory variation, especially for weaker LAC samples.
“International External Quality Assessment programs have shown significant inter-laboratory variation, especially for weaker LAC samples. 2,4,7”
From Clinical Relevance of Isolated Lupus Anticoagulant Positivity in Patients with Thrombotic Antiphospholipid Syndrome (2021) · cites this paper as [4]

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Reber G, Meijer P. In ECAT veritas? Lupus 2012;21:722-4.
Tincani A, Filippini M, Scarsi M, Galli M, Meroni PL. European attempts for the stan- dardisation of the antiphospholipid anti- bodies. Lupus 2009;18:913-9.

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Authors: Devreese, K. M. J.
Affiliations: Ghent University Hospital (BE)
Corresponding author: Devreese, K. M. J.
ORCID: Devreese, K. M. J.
Venue: International Journal of Laboratory Hematology
Publisher: Wiley
Published: 2014-04-18
Volume: 36
Issue: 3
Pages: 352-363
ISSN: 1751-5521 (ISSN-L)
1751-553X
DOI: 10.1111/ijlh.12234
OpenAlex: W2148616488
Cited by: 98
References: 86
Citations by year: 2026: 3 · 2025: 5 · 2024: 12 · 2023: 7 · 2022: 6 · 2021: 9 · 2020: 13 · 2019: 9 · 2018: 12 · 2017: 7 · 2016: 6 · 2015: 4 · 2014: 5
FWCI: 1.20
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 501 d)
Locations: International Journal of Laboratory Hematology (publishedVersion)
PubMed (publishedVersion)
Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Topics: Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords: antiphospholipid syndrome, antiphospholipid antibodies, lupus anticoagulant, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, assay standardization, inter-laboratory variability, diagnostic criteria
MeSH terms: Diagnostic Tests, Routine, Humans, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome, Antibodies, Antiphospholipid

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