ASTM E1326-13
(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
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...
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).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 recom...
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Designation: E1326 − 13
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 1.5 The values stated in SI units are to be regarded as
Heterotrophic (Standard) Plate Count, the Most Probable standard. No other units of measurement are included in this
Number (MPN) method and the Spread Plate Count are widely standard.
cited and accepted for the enumeration of microorganisms.
2. Referenced Documents
However, these methods have their limitations, such as perfor-
3
mance time and degree of accuracy. It is these limitations that
2.1 ASTM Standards:
have recently led to the marketing of a variety of non-
D1129 Terminology Relating to Water
conventional procedures, test kits and instruments.
D3870 PracticeforEstablishingPerformanceCharacteristics
for Colony Counting Methods in Microbiology (With-
1.2 A conventional test is one that is widely accepted and
4
drawn 2000)
published as a standard microbiological method or related
D4012 Test Method forAdenosineTriphosphate (ATP) Con-
procedure.Anew, nonconventional test method will attempt to
tent of Microorganisms in Water
provide the same information through the measurement of a
D5245 Practice for Cleaning Laboratory Glassware,
different parameter. This guide is designed to assist investiga-
Plasticware, and Equipment Used in Microbiological
torsinassessingtheaccuracyandprecisionofnonconventional
Analyses
methods intended for the determination of microbial popula-
D5465 Practice for Determining Microbial Colony Counts
tion densities or activities.
from Waters Analyzed by Plating Methods
1.3 It is recognized that the Heterotrophic Plate Count does
D7687 Test Method for Measurement of CellularAdenosine
notrecoverallmicroorganismspresentinaproductorasystem
Triphosphate in Fuel, Fuel/Water Mixtures, and Fuel-
2
(1, 2). When this problem occurs during the characterization
AssociatedWaterwithSampleConcentrationbyFiltration
of a microbiological population, alternative standard enumera-
D7847 GuideforInterlaboratoryStudiesforMicrobiological
tion procedures may be necessary, as in the case of sulfate-
Test Methods
reducing bacteria. At other times, chemical methods that
E691 Practice for Conducting an Interlaboratory Study to
measure the rates of appearance of metabolic derivatives or the
Determine the Precision of a Test Method
utilization of contaminated product components might be
E2694 Test Method for Measurement ofAdenosine Triphos-
indicated. In evaluating nonconventional tests, the use of these
phate in Water-Miscible Metalworking Fluids
alternative standard procedures may be the only means avail-
E2756 Terminology Relating to Antimicrobial and Antiviral
able for establishing correlation. In such cases, this guide can
Agents
serve as a reference for those considerations.
3. Terminology
1.4 Since there are so many types of tests that could be
considered nonconventional, it is impossible to recommend a
3.1 For definitions of terms used in this guide refer to
Terminologies D1129 and E2756.
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, 2013. Published October 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1990. Last previous edition approved in 2008 as E1326 – 08. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E1326-13. 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 C700, West Conshohocken, PA 19428-2959. United States
1
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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 − 08 E1326 − 13
Standard Guide 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
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
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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
3
2.1 ASTM Standards:
D1129 Terminology Relating to Water
4
D3870 Practice for Establishing Performance Characteristics for Colony Counting Methods in Microbiology (Withdrawn 2000)
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
D7687 Test Method for Measurement of Cellular Adenosine Triphosphate in Fuel, Fuel/Water Mixtures, and Fuel-Associated
Water with Sample Concentration by Filtration
D7847 Guide for Interlaboratory Studies for Microbiological Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E2694 Test Method for Measurement of Adenosine Triphosphate in Water-Miscible Metalworking Fluids
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, 2008Oct. 1, 2013. Published October 2008October 2013. Originally approved in 1990. Last previous edition approved in 20062008 as
E1326 – 06.E1326 – 08. DOI: 10.1520/E1326-08.10.1520/E1326-13.
2
The boldface numbers in parentheses refer to the list of references at the end of this guide.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
The last approved version of
...
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