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Analytical and clinical performance of a new, automated assay panel for the diagnosis of antiphospholipid syndrome
|Published in||Journal of Thrombosis and Haemostasis. 2010, vol. 8, no. 7, p. 1540-1546|
|Abstract||SUMMARY BACKGROUND: Anticardiolipin (aCL) and anti-beta(2)glycoprotein I (abeta(2)GPI) antibodies are part of the criteria for antiphospholipid syndrome (APS). Therefore they are widely measured and about 30 commercial kits are available. OBJECTIVES: To investigate the analytical and clinical performances of four fully automated, chemiluminescent assays: HemosIL AcuStar aCL IgG, HemosIL AcuStar aCL IgM, HemosIL AcuStar abeta(2)GPI IgG, and HemosIL AcuStar abeta(2)GPI IgM. METHODS: Cut-off values were assessed by testing 250 blood donors. Total coefficients of variation (CV) were determined with six plasma pools and two controls ranging from 4.3 to 2694 U mL(-1) depending on the assay. Samples from 218 well-characterized patients and 103 controls were measured in three laboratories to determine inter-laboratory variation. The results of the 321 samples were compared with three commercial assays (REAADS, INOVA and VARELISA). RESULTS: Cut-off values were assigned to 20 arbitrary units for all the tests. Total CV ranged from 4.3 to 11.2%. No interference of hemoglobin, bilirubin, triglycerides, heparins and rheumatoid factor was observed. Inter-laboratory variability was low and no sample changed status. Overall status agreement between HemosIL assays and the comparator kits ranged from 82 to 96%. Sensitivity, specificity, agreement when predicting APS and the odds ratios when predicting a thrombotic or obstetric event gave comparable results between HemosIL AcuStar and the three other assays. CONCLUSIONS: Our study demonstrates that the fully automated HemosIL AcuStar aPL assay panel showed similar performances to the three commercial ELISAs commonly used by various laboratories to detect antiphospholipid antibodies.|
|Keywords||Antibodies, Antiphospholipid/*blood — Antiphospholipid Syndrome/*diagnosis — Female — Humans — Luminescent Measurements/standards — Male — Observer Variation — Predictive Value of Tests — Pregnancy — Pregnancy Complications, Hematologic — Reagent Kits, Diagnostic/*standards — Reproducibility of Results — Sensitivity and Specificity — Thrombosis|
|Research group||Anticorps antiphospholipides (12)|
|DE MOERLOOSE, Philippe et al. Analytical and clinical performance of a new, automated assay panel for the diagnosis of antiphospholipid syndrome. In: Journal of Thrombosis and Haemostasis, 2010, vol. 8, n° 7, p. 1540-1546. https://archive-ouverte.unige.ch/unige:21199|