Classification Criteria for the Antiphospholipid Syndrome: Not the Same as Diagnostic Criteria for Antiphospholipid Syndrome

Favaloro, Emmanuel J.; Pasalic, Leonardo; Lippi, Giuseppe

doi:10.1055/s-0043-1776318

Cited by 9 publications

(2 citation statements)

References 26 publications

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“…Classification criteria are strict and meant for participant inclusion in studies and trials to study homogeneous populations of patients, contrary to laboratory diagnostic criteria, which are used in daily life to diagnose patients and optimize their care. Patients diagnosed with a disease do not necessarily meet the classification criteria for that disease, and improper use of classification criteria may lead to misdiagnosis 22 . We have to avoid using classification criteria for diagnostic purposes, and therefore the term “laboratory noncriteria APS” fits solely when classification criteria are applied and can only be used for research purposes and not for diagnosis of APS in a clinical setting.…”

Section: What Are Noncriteria Apl?mentioning

confidence: 99%

Noncriteria antiphospholipid antibodies in antiphospholipid syndrome

Devreese

2024

Int J Lab Hematology

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Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thrombotic manifestations and/or obstetric complications in patients with persistently positive antiphospholipid antibodies (aPL). aPL are a heterogeneous group of autoantibodies, but only lupus anticoagulant, anticardiolipin (aCL), and antibeta2‐glycoprotein I antibodies (aβ2GPI) IgG or IgM are included as laboratory classification criteria. Seronegative APS patients are usually defined as patients with the clinical symptoms of APS but who test negative for aPL. The negativity to classic aPL criteria does not exclude the presence of other aPL. Several noncriteria aPL have been identified. Some noncriteria aPL are well studied, such as IgA aCL and aβ2GPI, the antiphosphatidylserine‐prothrombin (aPS/PT) antibodies, and the antibodies against the domain I of beta2‐glycoprotein I (aDI), both latter groups receiving more attention for their role in thrombotic events and pregnancy complications. Other noncriteria aPL that have been studied are antibodies against annexin V, prothrombin, phosphatidylethanolamine, phosphatidic acid, phosphatidylserine, phosphatidylinositol, vimentin‐cardiolipin complex, anti‐protein S/protein C. Measurement of some of these noncriteria aPL (aPS/PT, aDI) is useful in the laboratory work‐out of APS in specific situations. We have to differentiate between patients who are positive for noncriteria aPL only, and patients who have both criteria and noncriteria aPL to enable us to study their role in the diagnosis or risk stratification of APS. The research on noncriteria aPL is continually developing as the clinical relevance of these antibodies is not yet fully clarified.

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Section: What Are Noncriteria Apl?mentioning

confidence: 99%

Noncriteria antiphospholipid antibodies in antiphospholipid syndrome

Devreese

2024

Int J Lab Hematology

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“…A more narrow set of classification criteria has been developed to identify “definite” APS, mainly for inclusion of patients into observational studies and clinical trials. Although these APS criteria help guide clinicians, APS may be diagnosed by a broader list of clinical and laboratory features than found in the classification criteria 6 . The classification of APS requires at least one clinical criterion (thrombosis or pregnancy complications) and one laboratory criterion (LA, the aPL which most strongly correlates with thrombosis, 2 anti‐β2‐glycoprotein 1 (anti‐β2‐GP1), and/or anticardiolipin antibodies (aCL) positivity) and confirmation of laboratory results 12 weeks after initial testing, 7–9 although in the newest classification criteria persistent LA positivity provides a higher score but is no longer a requirement for APS 5 .…”

Section: Introductionmentioning

confidence: 99%

Laboratory assessment of antiphospholipid syndrome: Laboratory data

Kobylecki,

Vedel‐Krogh,

Afzal

et al. 2024

Int J Lab Hematology

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IntroductionThorough assessment of the antiphospholipid syndrome (APS) includes retesting of positive antiphospholipid antibody (aPL) tests after at least 12 weeks, and a full antiphospholipid antibody profile. To what extent this work‐up is done in clinical practice is unknown.MethodsData on 25 116 in‐ and out‐hospital patients tested for the presence of lupus anticoagulant (LA), the aPL which most strongly correlates with thrombosis, was extracted from the laboratory information system of the only laboratory that performs LA tests in the Capital Region, Denmark. We estimated fraction of repeated tests, tests repeated within the recommended time span, and fraction with a full aPL profile.ResultsOut of 25 116 patients, 843 were positive for LA (3.3%), and 3948 results were inconclusive (16%). Only 51% (95% CI of the proportion: 48%–54%) (n = 431) of positive tests were repeated. The proportion of inconclusive LA test results increased from 13% (12%–15%) in 2009 to 20% (19%–22%) in 2020. Out of the positive tests repeated within the first year, only 60/353 (17%; 13%–21%) were repeated within 12–16 weeks; 177/353 (50%; 45%–55%) were re‐tested within the first 12 weeks of first positive test result. The proportion of patients with a full antiphospholipid antibody profile increased from 161/1978 (8%) in 2010 to 1041/1978 (43%) in 2020.ConclusionWe found several issues with the laboratory workup of APS. This indicates a need for increased awareness of comprehensive laboratory assessment of possible APS as well as a closer collaboration between the laboratory and clinicians.

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