Sending laboratory, method transfer

Method transfer is the situation in which the method is fully validated in one laboratory (sending laboratory) and transferred to another laboratory (receiving laboratory) and requires at least a partial validation. The parameters to evaluate during this partial validation are accuracy and precision of the method, selectivity, bench-top stability, and so on. 

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... 

All laboratories now have the obligation, not only to develop assays, but to get the assays into the hands of users. Rather than racing to develop new assays, possibly we should judge our success based on our ability to transfer the technology successfully to user laboratories. We routinely send reagents to other laboratories in the field. We try to send these reagents with a detailed protocol as well. Not that this is the best way to run the assay, but it represents a method that will give reliable results in the hands of both experts and neophytes. 

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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