Antiphospholipid antibody solid phase–based assays: problems and proposed solutions for the 2023 ACR/EULAR classification criteria for antiphospholipid syndrome

Recently the 2023 ACR/EULAR antiphospholipid syndrome (APS) classification criteria have been published (1).

However, from a laboratory analytical perspective, there are concerns regarding these recently published updated criteria. Our concerns are substantiated with data derived from the ECAT external quality assessment (EQA) program on aPL. We conclude that the new ACR/EULAR APS classification criteria regarding aPL testing using ELISA solid phase–based assays and fixed cut-off limits represent a step backward compared with the previous criteria. We advocate the reintroduction of the 99th percentile as the cut-off criterion for aPL solid phase assays, with automated platforms also serving as suitable aPL classification assays.

J Thromb Haemost. 2024;22:874–876
This publication can be approached via the following link: Anti‐PF4 testing for vaccine‐induced immune thrombocytopenia and thrombosis (VITT): Results from a NEQAS, ECAT and SSC collaborative exercise in 385 centers worldwide – Journal of Thrombosis and Haemostasis (jthjournal.org)

Reference:
1. Barbhaiya, M., S. Zuily, R. Naden, A. Hendry, F. Manneville, M.C. Amigo, et al., 2023 ACR/EULAR antiphospholipid syndrome classification criteria. Ann Rheum Dis, 2023; 82: 1258-1270.

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