Detection methods regulation, food validation

ICP-MS-coupled techniques are expected to increase in popularity, possibly leading to the commercial availability of ready-to-use speciation systems. Among the several approaches so far developed for species identification and quantification with ICP-MS detection in foods, some led to the establishment of sufficiently practicable and reliable analytical protocols for selected analytes/matrices. In a few cases, therefore, there is already the potential for validating routine control methods and this should facilitate the laying-down of species-specific regulations in the international legislation on trace elements in food. 

A new requirement of the final CLIA regulations is that laboratories must perform method validation studies oh all new tests introduced after April 24, 2003. Before this, laboratories that implemented new methods and analytical systems that had been cleared by the Food and Drug Administration (FDA) could simply follow manufacturers directions for operation and assume that the manufacturer s performance claims were valid. With the issuance of the final rule, the performance of all new tests must be validated in each laboratory to document the reportable range, precision, accuracy, and reference intervals. For some methods, it may also be necessary to determine the detection limit and to test for possible interferences. 

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