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Published on: October 23, 2011
Evaluating presence/absence of target microbes in microbiological tests
1U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Washington, DC 20204, USA.
Abstract:
A typical qualitative microbiological method performance (collaborative) study gathers a data set of responses about a test for the presence or absence of a target microbe. We developed 2 models that estimate false-positive and false-negative rates. One model assumes a constant probability that the tests will indicate the target microbe is present for any positive concentration in the test portion. The other model assumes that this probability follows a logistic curve. Test results from several method performance studies illustrate these estimates.
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