Revisiting the Phadia/EliA cut-off values for anticardiolipin and anti-β2-glycoprotein I antibodies: a systematic evaluation according to the guidelines

Lupus
M V BorJ J Sidelmann

Abstract

Background Phadia/EliA fluorescence enzyme immunoassays are widely used automated assays for anticardiolipin (aCL) and anti-β2-glycoprotein I (aβ2GPI) antibodies. To date, cut-off values for these assays have not been evaluated systematically and the evidence behind manufacturer's recommended cut-off values is not clear. Objective To determine Phadia/EliA cut-off values for antiphospholipid antibodies (aPL) according to the procedures suggested by guidelines. Methods A total of 266 blood donors (135 females and 131 males) were included. The pre-handling and analysis of the samples were performed according to the International Society on Thrombosis and Hemostasis (ISTH) guideline for solid phase aPL assays. Cut-off values and corresponding 90% confidence intervals (CI) for each antibody were established and outliers were handled according to the Clinical and Laboratory Standards Institute (CLSI) guideline for reference intervals. Samples from 377 consecutive patients, referred to our thrombophilia center with evidence of thrombosis or pregnancy morbidity were included for aPL testing. Results The in-house 99th (97.5th) percentile cut-off values were 11 (8.7), 12 (6.9) 8.5 (5.0) AU/mL for aβ2GPI IgG, IgM and IgA, and 21 (13) GPL-...Continue Reading

References

Aug 6, 2008·Journal of Thrombosis and Haemostasis : JTH·A RuffattiV Pengo
Jul 25, 2009·Journal of Thrombosis and Haemostasis : JTH·V PengoUNKNOWN Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the Interna
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Methods Mentioned

BETA
ELISA

Software Mentioned

Phadia
GraphPad
Excel
PRISM4

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Antiphospholipid Syndrome

Antiphospholipid syndrome or antiphospholipid antibody syndrome (APS or APLS), is an autoimmune, hypercoagulable state caused by the presence of antibodies directed against phospholipids.