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ASTM E 1326 : 2020

Current
Current

The latest, up-to-date edition.

Standard Guide for Evaluating Non-culture Microbiological Tests
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-15-2020

1.1The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test 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. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments.

1.2Culture test methods estimate microbial population densities based on the ability of mircoorganisms in a sample to proliferate in or on a specified growth medium, under specified growth conditions. Non-culture test methods attempt to provide the same or complimentary information through the measurement of a different parameter. This guide is designed to assist investigators in assessing the accuracy and precision of non-culture methods intended for the determination of microbial population densities or activities.

1.3It is recognized that the Heterotrophic Plate Count (HPC) does not recover all microorganisms present in a product or a system (1, 2).2 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, the utilization of contaminated product components or genetic profile of the microbial population might be indicated. In evaluating non-culture tests, it is possible that the use of these alternative standard procedures might be the only means available for establishing correlation. In such cases, this guide can serve as a reference for those considerations.

1.4Because there are so many types of tests that could be considered non-culture based, 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.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
E 35
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM E 1488 : 2012 : R2023 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
ASTM E 1488 : 2023 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
ASTM D 4012 : 2015 Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water
ASTM E 177 : 1990 : REV A : R1996 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM D 1129 : 2013 : R2020 Standard Terminology Relating to Water
ASTM D 4012 : 2023 : REV A Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water
ASTM D 1129 : 2013 : R2020 : EDT 2 Standard Terminology Relating to Water
ASTM E 691 : 2020 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 1129 : 2013 : R2020 : EDT 1 Standard Terminology Relating to Water
ASTM E 691 : 2019 : EDT 1 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2023 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 1601 : 1998 Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
ASTM E 691 : 2022 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 691 : 2009 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM D 4012 : 2023 Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water
ASTM E 1488 : 1996 Standard Guide for Statistical Procedures to Use in Developing and Applying ASTM Test Methods
ASTM D 4012 : 1981 : R1997 Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water
ASTM E 691 : 2021 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
ASTM E 1488 : 2012 : R2018 Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods

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