Robustness

Again this should be part of the portfolio supplied by the manufacturers but a limited in-house determination could be done by, for example, varying the age of the cultures when tested; age of any media or reagents used; using media at the extremes of the acceptable pH range etc.

With all of the above the main criteria being evaluated is equivalency (i.e., the proposed method is as consistent as the registered or pharmacopoeial method, when applied to well-characterized microorganisms in achieving an unequivocal identification). In our experience even the pharmacopoeial methods may not provide consistent identification.

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