RUGGEDNESS TESTS FOR ANALYTICAL CHEMISTRY

Mulholland, M. (1996). Ruggedness tests for analytical chemistry. In Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products (M. W. B. Hendriks, J. H. de Boer, and A. K. Smilde, Eds), pp. 191-232, Elsevier, Amsterdam. 

As an analytical approach to residue analysis, immunoassay methods are not well characterized, and no validation protocols have been established. The Association of Official Analytical Chemists, whose primary purpose is validation of analytical methods, established a Task Force on Test Kits and Proprietary Methods (2), which has addressed some of the issues relating to immunoassay methods. The International Union of Pure and Applied Chemistry s Commission on Food Chemistry has established a Working Group on Immunochemical Methods, whose first project is to develop draft guidelines on criteria for evaluation, validation, and quality control for r o-immunoassay methods (10). Similar guidelines for EIAs will also be developed. These documents will assist in development and standardization of requirements for precision for both between-laboratories and within-laboratory andyses, accuracy, and ruggedness, and— for qualitative methods— false positive and false negative rates. 

---