Evaluation of phosphatidylserine-dependent antiprothrombin antibody testing for the diagnosis of antiphospholipid syndrome: Results of an international multicentre study

O. Amengual, R. Forastiero, M. Sugiura-Ogasawara, Kotaro Otomo, K. Oku, C. Favas, J. Delgado Alves, P. Žigon, A. Ambrožič, M. Tomšič, I. Ruiz-Arruza, G. Ruiz-Irastorza, M. L. Bertolaccini, G. L. Norman, Z. Shums, J. Arai, A. Murashima, A. E. Tebo, M. Gerosa, P. L. MeroniI. Rodriguez-Pintó, R. Cervera, J. Swadzba, J. Musial, T. Atsumi

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27 Citations (Scopus)

Abstract

Objective A task force of scientists at the International Congress on Antiphospholipid Antibodies recognized that phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT) might contribute to a better identification of antiphospholipid syndrome (APS). Accordingly, initial and replication retrospective, cross-sectional multicentre studies were conducted to ascertain the value of aPS/PT for APS diagnosis. Methods In the initial study (eight centres, seven countries), clinical/laboratory data were retrospectively collected. Serum/plasma samples were tested for IgG aPS/PT at Inova Diagnostics (Inova) using two ELISA kits. A replication study (five centres, five countries) was carried out afterwards. Results In the initial study (n = 247), a moderate agreement between the IgG aPS/PT Inova and MBL ELISA kits was observed (k = 0.598). IgG aPS/PT were more prevalent in APS patients (51%) than in those without (9%), OR 10.8, 95% CI (4.0-29.3), p < 0.0001. Sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratio of IgG aPS/PT for APS diagnosis were 51%, 91%, 5.9 and 0.5, respectively. In the replication study (n = 214), a moderate/substantial agreement between the IgG aPS/PT results obtained with both ELISA kits was observed (k = 0.630). IgG aPS/PT were more prevalent in APS patients (47%) than in those without (12%), OR 6.4, 95% CI (2.6-16), p < 0.0001. Sensitivity, specificity, LR + and LR- for APS diagnosis were 47%, 88%, 3.9 and 0.6, respectively. Conclusions IgG aPS/PT detection is an easily performed laboratory parameter that might contribute to a better and more complete identification of patients with APS.

Original languageEnglish
Pages (from-to)266-276
Number of pages11
JournalLupus
Volume26
Issue number3
DOIs
Publication statusPublished - 2017 Jan 1
Externally publishedYes

Keywords

  • Antiphospholipid antibodies
  • lupus anticoagulant
  • systemic lupus erythematosus
  • thrombosis

ASJC Scopus subject areas

  • Rheumatology

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    Amengual, O., Forastiero, R., Sugiura-Ogasawara, M., Otomo, K., Oku, K., Favas, C., Delgado Alves, J., Žigon, P., Ambrožič, A., Tomšič, M., Ruiz-Arruza, I., Ruiz-Irastorza, G., Bertolaccini, M. L., Norman, G. L., Shums, Z., Arai, J., Murashima, A., Tebo, A. E., Gerosa, M., ... Atsumi, T. (2017). Evaluation of phosphatidylserine-dependent antiprothrombin antibody testing for the diagnosis of antiphospholipid syndrome: Results of an international multicentre study. Lupus, 26(3), 266-276. https://doi.org/10.1177/0961203316660203