Assessing the variation in antiphospholipid antibody (APA) assays: comparison of results from 10 centers - 25/08/11
, Rodney D. Franklin, BS
Reprint requests: William H. Kutteh, MD, PhD, Department of Obstetrics and Gynecology, The University of Tennessee Health Science Center, 80 Humphreys Center, Suite 307, Memphis, TN 38120-2363.Abstract |
Objective |
This study was undertaken to determine the variability of antiphospholipid antibody (APA) assay results of cardiolipin and other frequently tested phospholipids.
Study design |
Ten centers performing APA assays submitted samples that were positive in their assay. Twenty samples were identified to cover a broad range of APA results. Samples were distributed to the 10 participating centers for evaluation of immunoglobulin G (IgG), IgM, and IgA antibodies to phospholipids.
Results |
Of 20 patients, 9 (45%) were identified as positive by all 10 centers and 2 of 20 patients (10%) were identified as positive by 8 or 9 centers. However, 9 of 20 samples (45%) returned with mixed results. The average percent of positive samples was 29%, but results from the 10 centers ranged from a low number of positives (13%) to a high number of (37%).
Conclusion |
When considering a clinical diagnosis of APA syndrome, laboratory concordance of results from 20 patient samples among the 10 centers was only 55%. However, when considering a single phospholipid of a single immunoglobulin isotype, agreement of test results was 83.8%. Isolated positive APA results should be correlated with the clinical history and confirmed by repeat testing.
Le texte complet de cet article est disponible en PDF.Keywords : Antiphospholipid antibodies, Recurrent pregnancy loss, Antiphospholipid antibody syndrome, Anticardiolipin antibodies, Enzyme-linked immunoassay
Plan
 | Supported by a research grant from University of Tennessee. |
Vol 191 - N° 2
P. 440-448 - août 2004 Retour au numéro
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