In recent years, food microbiologists have seen the development of a range of nonstandard methods designed to enumerate or determine the presence of various microorganisms in food products. Generally the new methods are designed to give the microbiologist advantages, such as greater automation or faster results, over standard conventional methods. The new methods, however, have often not been thoroughly tested to give the end user confidence in the results. In order to generate data to show that new methods give results that are comparable with standard methods, they must be validated. A number of validation schemes have been developed in various countries throughout the world. There has not, however, been an acceptable scheme recognized throughout Europe. The MicroVal project has been involved in the development of a European microbiological method validation and certification scheme; it involves 21 partners from 7 EU member States. New methods that are tested by the MicroVal system will undergo initial testing in a single expert laboratory, to establish the test's specificity, limit of detection, relative accuracy, sensitivity, and linearity. This testing will be followed by a collaborative study in a minimum of eight laboratories, which will be used to determine the test precision, repeatability, and reproducibility. All results will be assessed by two expert reviewers who will recommend or reject the test. Tests that are recommended will be finally accepted by a MicroVal committee. The committee will pass its comments to one of several certification bodies (working together through a memorandum of understanding) who will certify that the new method gives results that are equivalent to the reference method used throughout the validation work. The technical rules that describe the work required to certify a method are currently being considered by the European Committee for Standardization (CEN), with the objective that the rules will become a CEN standard for the certification of new test methods. When this objective has been achieved the rules will become an International Standards Organization (ISO) standard for new test method validation.
Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium