ASTM E1326-20
(Guide)Standard Guide for Evaluating Non-culture Microbiological Tests
Standard Guide for Evaluating Non-culture Microbiological Tests
SIGNIFICANCE AND USE
5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and precision of the tests, as defined in Practice E691. Results of such studies should identify the limitations and indicate the utility or applicability of the non-culture test, or both, for use on different types of samples. Guide E1488 recommends other statistical tools for evaluating the suitability and applicability of proposed new test methods.
5.2 Non-culture test users and potential users should employ this guide to evaluate results of the non-culture test as compared to their present methods. Practices D5245 and D5465 should be reviewed in regards to the microbiological methods employed. If culture methods have not been used for monitoring the systems, then guidelines are included for obtaining microbiological expertise.
5.3 Utilization of a non-culture test can reduce the time required to determine the microbiological status of the system and detect microbe that are not detected by culture testing. Consequently, non-culture tests can contribute to the improvement in the overall operating efficiency of microbial contamination condition monitoring and diagnostic efforts, and microbicide performance evaluations.
5.4 Detecting microbial contamination levels that exceed predetermined upper control limits indicates the need for an addition of an antimicrobial agent or other corrective maintenance action. By accurately determining this in a shorter time period than is possible than by culture methods, treatment with antimicrobial agents may circumvent more serious problems than if the treatment were postponed until culture results were available. If the antimicrobial treatment program relied on an inaccurate non-culture test, then unnecessary loss of product and problems associated with inappropriate selection or improper dosing with antimicrobial agents would exist.
5.5 Since many methods based on entirely diff...
SCOPE
1.1 The 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.
1.2 Culture 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.
1.3 It 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...
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This 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.
Designation: E1326 − 20
Standard Guide for
1
Evaluating Non-culture Microbiological Tests
This standard is issued under the fixed designation E1326; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* means available for establishing correlation. In such cases, this
guide can serve as a reference for those considerations.
1.1 Thepurposeofthisguideistoassistusersandproducers
1.4 Because there are so many types of tests that could be
of non-culture microbiological tests in determining the appli-
considered non-culture based, it is impossible to recommend a
cabilityofthetestforprocessingdifferenttypesofsamplesand
specific test protocol with statistical analyses for evaluating the
evaluating the accuracy of the results. Culture test procedures
tests. Instead, this guide should assist in determining what
such as the Heterotrophic (Standard) Plate Count, the Most
types of tests should be considered to verify the utility and
Probable Number (MPN) method and the Spread Plate Count
identify the limitations of the nonconventional test.
are widely cited and accepted for the enumeration of microor-
ganisms. However, these methods have their limitations, such
1.5 The values stated in SI units are to be regarded as
as performance time. Moreover, any given culture test method
standard. No other units of measurement are included in this
typically recovers only a portion of the total viable microbes
standard.
presentinasample.Itistheselimitationsthathaverecentlyled
1.6 This international standard was developed in accor-
to the marketing of a variety of non-culture procedures, test
dance with internationally recognized principles on standard-
kits and instruments.
ization established in the Decision on Principles for the
1.2 Culture test methods estimate microbial population Development of International Standards, Guides and Recom-
densities based on the ability of mircoorganisms in a sample to mendations issued by the World Trade Organization Technical
proliferate in or on a specified growth medium, under specified Barriers to Trade (TBT) Committee.
growth conditions. Non-culture test methods attempt to pro-
2. Referenced Documents
vide the same or complimentary information through the
3
measurementofadifferentparameter.Thisguideisdesignedto
2.1 ASTM Standards:
assist investigators in assessing the accuracy and precision of
D1129 Terminology Relating to Water
non-culture methods intended for the determination of micro-
D4012 Test Method forAdenosineTriphosphate (ATP) Con-
bial population densities or activities.
tent of Microorganisms in Water
D5245 Practice for Cleaning Laboratory Glassware,
1.3 It is recognized that the Heterotrophic Plate Count
Plasticware, and Equipment Used in Microbiological
(HPC) does not recover all microorganisms present in a
2
Analyses
product or a system (1, 2). When this problem occurs during
D5465 Practices for Determining Microbial Colony Counts
the characterization of a microbiological population, alterna-
from Waters Analyzed by Plating Methods
tive standard enumeration procedures may be necessary, as in
E177 Practice for Use of the Terms Precision and Bias in
the case of sulfate-reducing bacteria. At other times, chemical
ASTM Test Methods
methods that measure the rates of appearance of metabolic
E691 Practice for Conducting an Interlaboratory Study to
derivatives, the utilization of contaminated product compo-
Determine the Precision of a Test Method
nents or genetic profile of the microbial population might be
E1488 GuideforStatisticalProcedurestoUseinDeveloping
indicated. In evaluating non-culture tests, it is possible that the
and Applying Test Methods
use of these alternative standard procedures might be the only
E1601 Practice for Conducting an Interlaboratory Study to
Evaluate the Performance of an Analytical Method
E2756 Terminology Relating to Antimicrobial and Antiviral
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,
Agents
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Dec. 1, 2020. Published December 2020. Originally
3
approved in 1990. Last previous edition approved in 2015 as E1326 – 15a. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E1326-20. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1326 − 15a E1326 − 20
Standard Guide for
1
Evaluating Non-culture Microbiological Tests
This standard is issued under the fixed designation E1326; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Scope*
1.1 The 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.
1.2 Culture 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.
1.3 It is recognized that the Heterotrophic Plate Count (HPC) does not recover all microorganisms present in a product or a system
2
(1, 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.
1.4 Because 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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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.
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2015Dec. 1, 2020. Published November 2015December 2020. Originally approved in 1990. Last previous edition approved in 2015 as
E1326 – 15.E1326 – 15a. DOI: 10.1520/E1326-15A.10.1520/E1326-20.
2
The boldface numbers in parentheses refer to the list of references at the end of this guide.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E1326 − 20
2. Referenced Documents
3
2.1 ASTM Standards:
D1129 Terminology Relating to Water
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 Practices for Determining Microbial Colony Counts from Waters Analyzed by Plating Methods
E177 Practice for Use of the Term
...
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