Good thread here with some interesting discussion. Excuse me for the dumb questions but I'd be silly not to ask them
FDA approval is based on safety and efficacy, which I assume has objective test parameters for various categories. Is your statement that the efficacy (in this case, specificity of the machine would relate to efficacy, while safety would be more about sensitivity) is not very good? if so, is this based on your professional opinion and past experience, or is this based on something you've seen in print?
I understand your point about colony morphology being very variable within species and you need confirmatory tests for specific situations. I doubt this will ever be removed, the confirmatory tests may be automated, but they will still need to be done for this variability.
However, you state that APAS could not ever be used for a positive result, is this truly the case? Would it not be able to determine the obvious yes and the obvious no tests?
for instance, if it was an E.coli strand that was completely straight forward to detect and had very identifiable characteristics to the eye, the machine could detect that?
Does this leave us with a machine that can give the following responses: No significant growth, significant growth + positive identification and Significant growth + negative identification.
2 out of 3 of those categories are then fully automated, while the third requires cofirmatory tests. This could make laboratories way more productive?
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