Key result
The candidate preparation 86/500 was established as the WHO 2nd International Standard for human IL-2 with an assigned activity of 210 IU/ampoule based on bioassay and immunoassay evaluation.
Establishes the WHO 2nd International Standard for human IL-2 with an assigned activity of 210 IU/ampoule.
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Provides reference for consistent IL-2 assay calibration; extends prior standards for reproducible research.
Two candidate preparations of human sequence recombinant Interleukin-2 (IL-2) were formulated and lyophilized at NIBSC prior to evaluation in a collaborative study for their suitability to serve as a replacement international standard. The preparations were tested by eight laboratories using in vitro bioassays and immunoassays. The candidate preparation 86/500 was judged suitable to serve as a replacement international standard based on the data obtained for activity and stability. On the basis of the results reported here, the preparation coded 86/500 was established by the WHO Expert Committee on Biological Standardisation (ECBS) in 2012 as the WHO 2nd IS for human IL-2 with an assigned value for IL-2 activity of 210IU/ampoule. Calibration of the 2nd IS is primarily based on the bioassay in use in various laboratories and relies exclusively on the estimates calculated relative to the WHO 1st IS for continuity of the IU.
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Wadhwa et al. (2013) studied this question. Candidate preparation 86/500 of human sequence recombinant Interleukin-2 vs. WHO 1st IS was evaluated on Suitability to serve as a replacement international standard based on activity and stability. The candidate preparation 86/500 was established as the WHO 2nd International Standard for human IL-2 with an assigned activity of 210 IU/ampoule based on bioassay and immunoassay evaluation.
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