1. Scope

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 of accuracy. It is these limitations that have recently led to the marketing of a variety of non-conventional procedures, test kits and instruments.

1.2 A conventional test is one that is widely accepted and published as a standard microbiological method or related procedure. A new, nonconventional test method will attempt to provide the same information through the measurement of a different parameter. This guide is designed to assist investigators in assessing the accuracy and precision of nonconventional methods intended for the determination of microbial population densities or activities.

1.3 It is recognized that the Heterotrophic Plate Count does not recover all microorganisms present in a product or a system (, ) . When this problem occurs during the characterization of a microbiological population, alternative standard enumeration procedures may be necessary, as in the case of sulfate-reducing bacteria. At other times, chemical methods that measure the rates of appearance of metabolic derivatives or the utilization of contaminated product components might be indicated. In evaluating nonconventional tests, the use of these alternative standard procedures may be the only means available for establishing correlation. In such cases, this guide can serve as a reference for those considerations.

1.4 Since there are so many types of tests that could be considered nonconventional, it is impossible to recommend a specific test protocol with statistical analyses for evaluating the tests. Instead, this guide should assist in determining what types of tests should be considered to verify the utility and identify the limitations of the nonconventional test.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D3870 Practice for Establishing Performance Characteristics for Colony Counting Methods in Microbiology

D4012 Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water

D5245 Practice for Cleaning Laboratory Glassware, Plasticware, and Equipment Used in Microbiological Analyses

D5465 Practice for Determining Microbial Colony Counts from Waters Analyzed by Plating Methods

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

Keywords

Accuracy assessment; Antimicrobial formulations/testing; Bacteria/bacterial control; Heterotrophic plate count procedure; Microbiological examination; Nonconventional testing procedures; Reproducibility; Sampling biological materials; Selectivity;

ICS Code

ICS Number Code 07.100.10 (Medical microbiology)

DOI: 10.1520/E1326-06

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