1. Scope
This guide will cover the methods used to measure the biological activity of the protein toxin ricin. This guide will provide the users with details and considerations for the methods so the data can be replicated by others. The recommendations include the measurement conditions and handling of the ricin materials to ensure that the results obtained from the activity measurements are done and reported in a uniform manner. This will allow the comparison of results from different laboratories using the same materials and facilitate the comparison of different lots of ricin used as reference materials. This guide will include several different methods that are currently used to measure the biological activity of ricin. The different methods require different equipment and training of the user. We do make recommendations for the number or specific measurement methods that should be used, but to ensure that if a measurement method is used, that it be reported in sufficient detail to permit the reliable replication of the measurements. We have included the use of controls in the measurements to ensure a reliable measurement. The guide is aimed at the manufactures of ricin reference materials, as well as the customers as end users. The guide will provide recommendations for the presentation of data, the details, and conditions of the measurement techniques in the form of a report of analysis (ROA). The ROA will provide the users of the reference materials with sufficient detail to replicate the measurements in their own laboratories. The endusers would be able to perform any measurements to ensure that the biological activity of the material has not changed during shipping and storage of the material. This standard guide also incorporates recommendations for the handling and storage of ricin to preserve the biological activity, including storage. The guide also includes recommendations to the references safe handling of this dangerous toxin in the laboratory.
The development of uniform and well-characterized reference materials will improve the quality of the data obtained from detection devices and laboratory instruments. These materials can also be used to test environmental sampling methods and remediation technologies Ricin is a protein toxin that is found in high concentrations in the castor beans and it has been used as a weapon of biological terrorism. Uniform methods or standards are needed for the measurement of the biological activity of ricin. The biological activity results in cell death due to a set of complex interactions between the ricin molecule and the cell target. The biological activity of different preparations of ricin will vary widely, so it is important to have a uniform method to compare different reference materials. It is also important to be able to reliably measure the biological activity of the ricin to determine the effectiveness of remediation technologies and inactivation procedures. Mammalian cell culture is an essential tool to study the complex biological processes. A number of important variables need to be considered including, the cell type, the passage number of the cells, culture condition, method of ricin introduction, and the methods used to measure cell cytotoxicity. The guide on ricin will focus on the biological activity of ricin, including cell-based assays, cell-free translation systems and enzymatic measurements. The standard guide will present an organized and uniform approach to aid manufactures and users of material in the characterization and reporting of the properties of these materials. The use of well-defined reference materials will result in improved data will increase the confidence of the results obtained and facilitate the meaningful comparisons of results are obtained from different labs, trials and devices.
Keywords
ricin; toxin; protein; detection; ribosome inhibitor; biological activity;
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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