ASTM E1326-08
(Guide)Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
SIGNIFICANCE AND USE
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 E 691 and D 3870. 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.
Nonconventional test users and potential users should employ this guide to evaluate results of the nonconventional test as compared to their present methods. Practices D 5245 and D 5465 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.
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.
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.
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 (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 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 s...
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Designation: E1326 − 08
StandardGuide for
Evaluating Nonconventional Microbiological Tests Used for
1
Enumerating Bacteria
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 specific test protocol with statistical analyses for evaluating the
tests. Instead, this guide should assist in determining what
1.1 Thepurposeofthisguideistoassistusersandproducers
types of tests should be considered to verify the utility and
of nonconventional tests in determining the applicability of the
identify the limitations of the nonconventional test.
testforprocessingdifferenttypesofsamplesandevaluatingthe
accuracy of the results. Conventional procedures such as the
2. Referenced Documents
Heterotrophic (Standard) Plate Count, the Most Probable
3
2.1 ASTM Standards:
Number (MPN) method and the Spread Plate Count are widely
cited and accepted for the enumeration of microorganisms. D3870 PracticeforEstablishingPerformanceCharacteristics
for Colony Counting Methods in Microbiology (With-
However, these methods have their limitations, such as perfor-
4
mance time and degree of accuracy. It is these limitations that drawn 2000)
D4012 Test Method forAdenosineTriphosphate (ATP) Con-
have recently led to the marketing of a variety of non-
conventional procedures, test kits and instruments. tent of Microorganisms in Water
D5245 Practice for Cleaning Laboratory Glassware,
1.2 A conventional test is one that is widely accepted and
Plasticware, and Equipment Used in Microbiological
published as a standard microbiological method or related
Analyses
procedure.Anew, nonconventional test method will attempt to
D5465 Practice for Determining Microbial Colony Counts
provide the same information through the measurement of a
from Waters Analyzed by Plating Methods
different parameter. This guide is designed to assist investiga-
E691 Practice for Conducting an Interlaboratory Study to
torsinassessingtheaccuracyandprecisionofnonconventional
Determine the Precision of a Test Method
methods intended for the determination of microbial popula-
tion densities or activities.
3. Summary of Guide
1.3 It is recognized that the Heterotrophic Plate Count does
3.1 ASTM standard practices are referenced for use by
notrecoverallmicroorganismspresentinaproductorasystem
producers and users to determine the potential utility of the
2
(1, 2). When this problem occurs during the characterization
nonconventional test. Users of tests who are unequipped for
of a microbiological population, alternative standard enumera-
performing standard microbiological tests are given recom-
tion procedures may be necessary, as in the case of sulfate-
mendations for seeking out microbiological laboratories that
reducing bacteria. At other times, chemical methods that
could perform collaborative studies to evaluate and verify the
measure the rates of appearance of metabolic derivatives or the
information generated with the nonconventional tests.
utilization of contaminated product components might be
indicated. In evaluating nonconventional tests, the use of these
4. Significance and Use
alternative standard procedures may be the only means avail-
4.1 This guide should be used by producers and potential
able for establishing correlation. In such cases, this guide can
producers of nonconventional tests to determine the accuracy,
serve as a reference for those considerations.
selectivity, specificity, and reproducibility of the tests, as
1.4 Since there are so many types of tests that could be
defined in Practices E691 and D3870. Results of such studies
considered nonconventional, it is impossible to recommend a
should identify the limitations and indicate the utility or
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
3
Subcommittee E35.15 on Antimicrobial Agents. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2008. Published October 2008. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1990. Last previous edition approved in 2006 as E1326 – 06. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E1326-08. the ASTM website.
4
2
The boldface numbers in parentheses refer to the list of references at the end of The last approved version of this historical standard is referenced on
this guide. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:E 1326–06 Designation:E 1326–08
Standard Guide for
Evaluating Nonconventional Microbiological Tests Used for
1
Enumerating Bacteria
This standard is issued under the fixed designation E 1326; 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
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 Aconventional 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 (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 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
3
2.1 ASTM Standards:
4
D 3870 Practice for Establishing Performance Characteristics for Colony Counting Methods in Microbiology
D 4012 Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Water
D 5245 Practice for Cleaning Laboratory Glassware, Plasticware, and Equipment Used in Microbiological Analyses
D 5465 Practice for Determining Microbial Colony Counts from Waters Analyzed by Plating Methods
E 691Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E2250Method for Determination of Endotoxin Concentration inWater Miscible MetalWorking Fluids Practice for Conducting
an Interlaboratory Study to Determine the Precision of a Test Method
3. Summary of Guide
3.1 ASTM standard practices are referenced for use by producers and users to determine the potential utility of the
nonconventional test. Users of tests who are unequipped for performing standard microbiological tests are given recommendations
for seeking out microbiological laboratories that could perform collaborative studies to evaluate and verify the information
generated with the nonconventional tests.
1
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides and Alternative Control Agents and is the direct responsibility of Subcommittee E35.15 on
Antimicrobial Agents.
Current edition approved Nov.Oct. 1, 2006.2008. Published November 2006.October 2008. Originally approved in 1990. Last previous edition approved in 19982006 as
E1326–98.E 1326 – 06.
2
The boldface numbers in parentheses refer to the list of references at the end of this guide.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on
...
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