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Palme, Stefan; Christenson, Robert H.; Jortani, Saeed A.; Ostlund, Richard E.; Kolm, Ruediger; Kopal, Guido; Laubender, Ruediger P. (2017): Multicenter evaluation of analytical characteristics of the Elecsys® Periostin immunoassay. In: Clinical Biochemistry, Vol. 50, No. 3: pp. 139-144
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Objective: The multifunctional cytokine IL-13 is thought to play a central role in Type 2 inflammation in asthma. Serum periostin has been explored as a candidate biomarker for evaluating IL-13 activity in the airway. We describe the technical performance characteristics of a novel, fully automated immunoassay for the determination of periostin in serum. Design and methods: Limit of blank [LoB], limit of detection [LoD] and limit of quantitation [LoQ], linearity, precision and reproducibility across sites and lots were evaluated according to Clinical and Laboratory Standards Institute guidelines. Interferences and sample stability were also investigated. Results: The pre-specified values for LoB (2 ng/mL), LoD (4 ng/mL) and LoQ (10 ng/mL) were met. The assay was linear throughout the measuring range (10-160 ng/mL) with recoveries within +/- 10% of target at concentrations >30 ng/mL and within +/- 3 ng/mL at concentrations <= 30 ng/mL. Recovered periostin concentrations were also within 10% of target in presence of 43 potentially interfering substances and drugs. Samples were stable across various storage conditions and durations (24 h at room temperature, 7 days at 4 degrees C, 12 weeks at - 20 degrees C, and 3 freeze/thaw cycles). Repeatability experiments resulted in CVs across samples and controls ranging from 0.9-1.5%. Intermediate precision was 1.2-1.7% and reproducibility including 3 testing sites and 3 reagent lots was 1.7-3.1%. The final assay correlates to the assay version used in previous clinical trials (Pearson's r = 0.998, bias at 50 ng/mL = 1.2%). Conclusion: The performance evaluation of the Elecsys (R) Periostin immunoassay including a multicenter precision analysis demonstrated that the assay is suitable for measuring serum periostin at clinically important concentrations around 50 ng/mL (C) 2016 The Authors. Published by Elsevier Inc. on behalf of The Canadian Society of Clinical Chemists.