A review of 10 years of data from an external quality assurance program for antiphospholipid antibodies: no evidence for improved aCL and β2GPI assay standardization

Wienholt, Louise; Richardson, Alexander; Wong, Richard; Chapman, Kristie; Lee, Frederick J.

doi:10.21037/aob.2019.10.01

Cited by 5 publications

(5 citation statements)

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“…Moreover, the type of solid assay employed and intra-assay variability might also influence aPL results. 21 Lastly, it is important to consider that aPL titer variation can depend on type and length of immunomodulatory/immunosuppressant drugs used in patient treatment, as previously reported in retrospective studies. 8,9,[22][23][24][25][26][27] When looking at the literature published to date, in regard to the definition of aPL seroconversion, most of the authors agree on the need of at least two consecutive negative aPL determinations, but the reported intervals between the two determinations are heterogeneous, ranging from12 weeks to 1 year, and from 20 months to more than 5 years for clinical follow-up.…”

Section: Discussionmentioning

confidence: 96%

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Clinical Delphi on aPL Negativization: Report from the APS Study Group of the Italian Society for Rheumatology (SIR-APS)

et al. 2022

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The rate of antiphospholipid antibodies (aPL) negativization in antiphospholipid syndrome (APS) patients is uncertain, but it is estimated to be as high as 8%. Currently, a consensus definition of aPL negativization is lacking, as well as international recommendations on how to approach treatment in patients with a persistent aPL negative seroconversion. Evaluate the clinical approach and level of consensus among experts from the APS Study Group of the Italian Society for Rheumatology (SIR-APS) in different clinical scenario. Experts of SIR-APS were contacted using a survey methodology. A structured survey was circulated among 30 experts.Up to 90% of the interviewed experts agreed on defining aPL negativization as the presence of two negative determinations, one year apart (90%).Almost full consensus exist among experts in some clinical settings, including: a) the role of aPL negativization in the management of a thrombotic event determined by concomitant presence of cardiovascular risk factors, both modifiable and not modifiable (90%); b) approach to young patients with triple aPL positivity who experienced pulmonary arterial thrombotic event and tested negative for aPL detection after five year of vitamin K antagonist (VKA) treatment (90%); c)the use of “extra criteria” aPL antibodies testing before pondering VKA suspension (93%). A substantial agreement exists among expert on how to define aPL negativization. VKA suspension should be embraced with extreme caution, particularly in case of previous thrombotic events and/or triple aPL positivity. Nevertheless, VKA cessation might be considered when risk factors are carefully monitored/treated and the presence for “extra criteria” is ruled out.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 96%

Clinical Delphi on aPL Negativization: Report from the APS Study Group of the Italian Society for Rheumatology (SIR-APS)

et al. 2022

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“…Best illustrated by external quality control programs, 24 27 this inter-assay variation remains a major concern. In a real-world setting on a large cohort of APS and non-APS patient samples, we have recently shown that with commercially available solid phase assays, even with eliminating inter-laboratory and inter-operator variation, there is still variable detection of aCL and aβ2GPI IgG/M between platforms.…”

Section: Agreement Between Solid Phase Assaysmentioning

confidence: 99%

Solid Phase Assays for Antiphospholipid Antibodies

Devreese

2022

Semin Thromb Hemost

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The diagnosis of antiphospholipid syndrome (APS) relies on the detection of circulating antiphospholipid antibodies (aPL). Currently, lupus anticoagulant (LA), anticardiolipin (aCL), and anti-β2-glycoprotein I antibodies (aβ2GPI) IgG or IgM are the laboratory criteria if persistently present over time. As aCL and aβ2GPI are two out of the three laboratory criteria, the detection of aPL by solid phase assays is an essential step in the diagnosis of APS. Advancement has been made to resolve some of the methodological challenges of aCL and aβ2GPI assays by providing guidelines how to measure aPL, as well as to gain a better understanding of their diagnostic role. However, solid phase assays for aCL and aβ2GPI still show substantive inter-assay differences, resulting in disagreement concerning positive/negative results, but also differences in titer of antibodies. This hampers the semiquantitative classification into low-medium-high positivity. The non-criteria aPL, such as antibodies against the domain one of β2GPI and anti-phosphatidylserine/prothrombin antibodies (aPS/PT) have roles in confirming the risk in APS, and can be useful, especially in patients with incomplete antibody profiles.

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“…6,7 Solid phase assays are not prone to interferences as described for LAC assays but lack standardization and demonstrate intra-and inter-assay variation. 6,[8][9][10] Debate is ongoing whether aPL that are currently not included in the laboratory criteria for APS (so called non-criteria aPL) can add value to the diagnosis or risk stratification in APS. Non-criteria aPL include aCL and aβ2GPI of the IgA isotype, antiphosphatidylserine/ prothrombin antibodies (aPS/PT) IgG/IgM, and anti-domain I β2GPI IgG.…”

Section: Introductionmentioning

confidence: 99%

“…aCL and aβ2GPI IgG/IgM are measured by solid phase assays using techniques such as enzyme‐linked immunosorbent assay (ELISA) or chemiluminescent immunoassay (CLIA) 6,7 . Solid phase assays are not prone to interferences as described for LAC assays but lack standardization and demonstrate intra‐ and inter‐assay variation 6,8–10 …”

Section: Introductionmentioning

confidence: 99%

Added value of antiphosphatidylserine/prothrombin antibodies in the workup of thrombotic antiphospholipid syndrome: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Vandevelde

Chayouâ

Laat

et al. 2022

Journal of Thrombosis and Haemostasis

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A review of 10 years of data from an external quality assurance program for antiphospholipid antibodies: no evidence for improved aCL and β2GPI assay standardization

Cited by 5 publications

References 0 publications

Clinical Delphi on aPL Negativization: Report from the APS Study Group of the Italian Society for Rheumatology (SIR-APS)

Clinical Delphi on aPL Negativization: Report from the APS Study Group of the Italian Society for Rheumatology (SIR-APS)

Solid Phase Assays for Antiphospholipid Antibodies

Added value of antiphosphatidylserine/prothrombin antibodies in the workup of thrombotic antiphospholipid syndrome: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

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