Laboratory compatibility, method transfer

In the field of clinical chemistry a complete structure of methods and materials was proposed in the late 1970s for better accuracy and compatibility of laboratory results (Boutwell, 1977 Alvares et al., 1982). The system includes primary and secondary reference materials and control materials, as well as definitive, reference, and laboratory methods. Each of the materials or methods would guarantee the transfer of accuracy from the highest level to the final routine level of the laboratories. For this transfer the three types of materials would in principle be used in conjunction with the three levels of methods. A schematic overview of this system would be as follows ... 

Successful method transfer requires a good match of skills, experience, and team dynamics between the sending and receiving laboratories. If contract research organizations are involved, the initial selection step of a suitable contractor requires an evaluation of these compatibilities. However, if the transfer occurs within an organization or as part of already existing partnerships, the match between labs may be... 

When identifying suitable testing labs, the main emphasis should be on the method application requirements, for example, sample analysis for preclinical or clinical studies, testing in conformance with GLP guidelines and, last but not least, the extent and philosophy of method validation between the laboratories. The selection of a compatible laboratory as the receiving laboratory is pivotal to the success of the method transfer process. 

Compatibility of instruments is one of the criteria to be assessed early on to assure that assays can be transferred more reliably. Incubators, plate washers, and plate readers (including analysis software) are critical in assuring comparable method performance between laboratories. Ideally, sending and receiving labs should run their methods on equivalent equipment. If not, assay conditions may have to be adapted and the assay transfer could become significantly more cumbersome, requiring additional supportive partial validation. 

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