Minimal requirements for antiphospholipid antibodies ELISAs proposed by the European Forum on antiphospholipid antibodies

Tincani, Anǵela; Allegri, F.; Balestrieri, G.; Reber, Guido; Sanmarco, Marielle; Meroni, Pier Luigi; Boffa, Maurice

doi:10.1016/j.thromres.2004.06.035

Cited by 134 publications

(122 citation statements)

References 13 publications

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“…Although there is room for improved standardization (55 ), better agreement is found between different assays compared with aCL antibody assays (51 ). Laboratories measuring anti-␤2GPI antibodies are encouraged to follow the guidelines proposed by the standardization group of the European Forum on Antiphospholipid Antibodies (62 ).…”

Section: Apas Measured By Elisamentioning

confidence: 99%

Challenges in the Diagnosis of the Antiphospholipid Syndrome

Devreese

Hoylaerts

2010

Clinical Chemistry

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BACKGROUND:The antiphospholipid syndrome (APS) is an important cause of acquired thromboembolic complications and pregnancy morbidity. Its diagnosis is based on clinical and laboratory criteria, defined by strict guidelines. The original clinical and laboratory criteria for the identification of APS patients were published in 1999, in the so-called Sapporo criteria. In 2006 these criteria were revised, and recently more precise guidelines for analysis of the lupus anticoagulant have been provided. However, several questions related to the diagnosis of APS remain unanswered.CONTENT: In addition to providing a historical perspective, this review covers several challenges in the diagnosis of APS with respect to clinical and laboratory features, while highlighting pathogenic pathways of the syndrome. We discuss ongoing dilemmas in the diagnosis of this complex disease. Although antiphospholipid antibodies are found in association with various clinical manifestations, the older established clinical criteria were not substantively altered in the 2006 update. Several laboratory tests recommended in the latest criteria, including phospholipid-dependent coagulation tests for the detection of the lupus anticoagulant and ELISAs for measuring anticardiolipin and ␤2-glycoprotein I antibodies, still show methodological and diagnostic shortcomings. In addition, antiphospholipid antibodies have been described against other antigens, but their clinical role remains uncertain.

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Section: Apas Measured By Elisamentioning

confidence: 99%

Challenges in the Diagnosis of the Antiphospholipid Syndrome

Devreese

Hoylaerts

2010

Clinical Chemistry

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“…The combinations SCT/dRVVT and dRVVT/APTT were both associated with IgG antibodies to b 2 -GPI. The significant association of SCT alone or combined with dRVVT with the most clinically important aPLELISAs, such as IgG anti-b 2 -GPI and IgG aCL (16)(17)(18), underlines its important clinical value. These results confirm that this new commercial SCT assay is a sensitive and specific test for diagnosing LA in patients with APS-related thrombosis.…”

Section: Discussionmentioning

confidence: 99%

Use of a new silica clotting time for diagnosing lupus anticoagulant in patients who meet the clinical criteria for antiphospholipid syndrome

Grypiotis

Ruffatti

Pengo

et al. 2006

Clinical Laboratory Analysis

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The silica clotting time (SCT) is a phospholipid-dependent coagulation assay used for the laboratory diagnosis of lupus anticoagulant (LA) antibodies. The sensitivity and specificity of a new commercial SCT for identifying LA in patients who meet the clinical criteria for antiphospholipid syndrome (APS), and its association with thrombotic events were evaluated here. Forty-five patients who met the clinical criteria for APS according to the Sapporo International Consensus Statement were examined. Sixty-nine patients who did not meet the clinical criteria for APS, and 20 blood donors were used as controls. Plasma samples from the patients and controls were tested for LA using a new commercial SCT with low and high synthetic phospholipid concentrations. The results were compared with those obtained by diluted Russell's viper venom time (dRVVT) and activated partial thromboplastin time (APTT). SCT's sensitivity for identifying LA in patients who met the clinical criteria of APS was higher compared to APTT and dRVVT (53.3% vs. 31.1% and 31.1%), and the specificities of these assays were 96.6%, 100%, and 98.9%, respectively. When dRVVT was combined with SCT, and dRVVT was combined with APTT their sensitivities were 57.7% and 48.8%, and their specificities were 96.6% and 98.9%, respectively. A stepwise logistic regression analysis indicated that the combination of dRVVT with SCT was associated with total thrombotic events (odds ratio (OR) 5 11.5, 95% confidence interval (CI) 5 1.25-106.3, P 5 0.031) as well as with venous thrombosis (OR 5 4.09, 95% CI 5 1.16-14.43, P 5 0.028). According to our results, SCT is the most sensitive assay for identifying LA in patients who meet the clinical criteria for APS. Moreover, the highest sensitivity was reached with a combination of SCT and dRVVT. The method's association with total thrombotic events and venous thrombosis was in fact significant.

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“…LA was performed according to international guidelines [54]. aCL IgG/IgM and anti-β2GPI IgG/IgM were detected by internationally validated in-house ELISA assays [55]. The fine specificities of anti-β2GPI IgG antibodies was investigated using prototype research ELISAs developed by INOVA Diagnostics (San Diego, California, USA).…”

Section: β2 Glycoprotein I Domain Specificities In An Italian Monocenmentioning

confidence: 99%

Reactivity against the Five Domains of β2 Glycoprotein I: A Focus on Systemic Lupus Erythematosus

Chighizola¹,

Borghi²,

Grossi³

et al. 2014

J Clin Cell Immunol

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Beta-2 glycoprotein I (β 2 GPI) is the main antigenic target for antiphospholipid antibodies (aPL), the serological markers of antiphospholipid syndrome (APS), a systemic autoimmune disease characterized by vascular thrombosis and/or pregnancy morbidity. aPL are detected in 20 to 50% of patients with systemic lupus erythematosus (SLE), representing a poor prognostic factor. Indeed, thrombotic events heralds high morbidity and mortality, being regarded as the strongest predictors of death in the first five years after SLE onset. It would be thus very important to identify a reliable laboratory tool such as anti-domain antibodies to better risk-stratify lupus patients according to the aPL profile, in order to tailor treatment strategies. Domain I (DI) of β 2 GPI has lately been identified as the main epitope targeted by antibodies reacting against β 2 GPI isolated from APS patients, well correlating with thrombotic as well as obstetric manifestations. Interestingly, anti-DI antibodies have been shown to well correlate with lupus anticoagulant and to predict the clinical manifestations of the syndrome, thrombotic events as well as pregnancy complications. Further, anti-DI antibodies allow to identify patients at highest clinical risk, presenting a good specificity for APS. On the other hand, anti-β 2 GPI antibodies from aPL asymptomatic carriers or subjects with infectious diseases preferentially display reactivity towards DIV or DV of the molecule.Few studies have to date evaluated the domain profile of anti-β 2 GPI antibodies in subjects with SLE, even though it would be very relevant from a clinical point of view to understand whether among patients with SLE the domain specificities of anti-β 2 GPI antibodies display a clinical meaning comparable to the one they exert in APS. It is therefore rather appropriate to review the available evidence about anti-domain specificities with a particular focus on SLE.

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Minimal requirements for antiphospholipid antibodies ELISAs proposed by the European Forum on antiphospholipid antibodies

Cited by 134 publications

References 13 publications

Challenges in the Diagnosis of the Antiphospholipid Syndrome

Challenges in the Diagnosis of the Antiphospholipid Syndrome

Use of a new silica clotting time for diagnosing lupus anticoagulant in patients who meet the clinical criteria for antiphospholipid syndrome

Reactivity against the Five Domains of β2 Glycoprotein I: A Focus on Systemic Lupus Erythematosus

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