Ruggedness

As for qualitative methods, this data is probably best obtained from the equipment manufacturers, who will have access to multiple instruments, multiple reagent lots, etc. It would normally be demonstrated across a range of microorganisms performing a number of replicates (5 to 10), while the parameters chosen are varied. For a user, this study will probably be limited to using different analysts, different lots of reagents, and different lots of media. The impact could be measured using the coefficient of variation which should be in the range of 10 to 15%.

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