| Autor: |
Lydia Greenlees, Reena Varkey, Maria J. Datwyler, Ethan Grant, Melissa Parker, Rozanne Lee, Scott Manetz, Partha Choudhury, Katie Streicher, Meina Liang, Koustubh Ranade, Nicolette M. Jeanblanc, Gerard Davis |
| Rok vydání: |
2015 |
| Předmět: |
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| Zdroj: |
5.1 Airway Pharmacology and Treatment. |
| Popis: |
Rationale: Serum periostin has been proposed as a systemic biomarker of IL-13 pathway activation in the lung. We developed an investigational use only (IUO) immunoassay to detect serum periostin on the ARCHITECT® immunoassay i System. Methods: The ARCHITECT® Periostin assay is a two-step immunoassay for quantitative determination of periostin in human serum using Chemiluminescent Magnetic Immunoassay (CMIA) technology. Periostin is captured by microparticles coated with an anti-periostin monoclonal antibody (mAb). After incubation and washing, a second anti-periostin mAb conjugated with acridinium is added, chemiluminesence is triggered, and signal is measured as relative light units (RLUs). Amount of periostin present and RLUs detected are directly correlated. ARCHITECT® i System has 200 tests per hour throughput. The analytical performance of the assay was assessed. Results: A sandwich immunoassay format was optimized for robust analytical performance. Five-day precision results were 1000 serum samples from patients with severe asthma. The range was 5.2-73.3 ng/mL and median periostin level was 16.44 ng/mL. Conclusions: The IUO ARCHITECT® Periostin immunoassay is a reliable and robust test to measure serum periostin levels. The assay is being used in ongoing Phase 3 trials of tralokinumab, a human IgG4 mAb that neutralizes IL-13. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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