5.1 This guide should be used by producers and potential producers of nonconventional tests to determine the accuracy, selectivity, specificity, and reproducibility of the tests, as defined in Practices E691 and D3870. Results of such studies should identify the limitations and indicate the utility or applicability of the nonconventional test, or both, for use on different types of samples.
5.2 Nonconventional test users and potential users should employ this guide to evaluate results of the nonconventional test as compared to their present methods. Practices D5245 and D5465 should be reviewed in regards to the conventional microbiological methods employed. If conventional methods have not been used for monitoring the systems, then guidelines are included for obtaining microbiological expertise.
5.3 Utilization of a nonconventional test may reduce the time required to determine the microbiological status of the system and enable an improvement in the overall operating efficiency. In many cases, the findings of a significantly high level of bacteria indicates the need for an addition of an antimicrobial agent. By accurately determining this in a shorter time period than by conventional methods, treatment with antimicrobial agents may circumvent more serious problems than if the treatment were postponed until conventional results were available. If the antimicrobial treatment program relies on an inaccurate nonconventional test, then unnecessary loss of product and problems associated with inappropriate selection or improper dosing with antimicrobial agents would exist.
5.4 Since many methods based on entirely different chemical and microbiological principles are considered, it is not possible to establish a unique design and recommend a specific method of statistical analyses for the comparisons to be made. It is only possible to present guides that should be followed while performing the experiments. It is also recommended that a statistician be involved in the study.
5.5 There are various ways for categorizing microbiological test methods. One valid approach is to differentiate between methods intended to quantify a particular microbe from those intended to quantify overall bioburden.
5.5.1 Methods used to quantify a single microbe typically can be evaluated for precision (Practice E691). Even though it is unlikely that reference standards exist, often these methods can also be evaluated for bias relative to other methods used to detect the same microbe.
5.5.2 Methods used to quantify total populations are more problematic in terms of precision and bias testing. Guide D7847 addresses many of the factors that confound efforts to determine the precision of microbiological test methods used to quantify microbial contamination in fuels and fuel systems. Many of these issues are broadly relevant to the challenge of developing relevant precision terms for microbiological test methods used to quantify total bioburdens in industrial systems.
1.1 The purpose of this guide is to assist users and producers of nonconventional tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Conventional procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time and degree o......
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