ASTM_E_1326_-_15a.pdf

Designation:E132615aStandard Guide forEvaluating Non-culture Microbiological Tests1This standard is issued under the fixed designation E1326;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 The purpose of this guide is to assist users and producersof non-culture microbiological tests in determining the appli-cability of the test for processing different types of samples andevaluating the accuracy of the results.Culture test proceduressuch as the Heterotrophic(Standard)Plate Count,the MostProbable Number(MPN)method and the Spread Plate Countare widely cited and accepted for the enumeration of microor-ganisms.However,these methods have their limitations,suchas performance time.Moreover,any given culture test methodtypically recovers only a portion of the total viable microbespresent in a sample.It is these limitations that have recently ledto the marketing of a variety of non-culture procedures,testkits and instruments.1.2 Culture test methods estimate microbial populationdensities based on the ability of mircoorganisms in a sample toproliferate in or on a specified growth medium,under specifiedgrowth conditions.Non-culture test methods attempt to pro-vide the same or complimentary information through themeasurement of a different parameter.This guide is designed toassist investigators in assessing the accuracy and precision ofnon-culture methods intended for the determination of micro-bial population densities or activities.1.3 It is recognized that the Heterotrophic Plate Count(HPC)does not recover all microorganisms present in aproduct or a system(1,2).2When this problem occurs duringthe characterization of a microbiological population,alterna-tive standard enumeration procedures may be necessary,as inthe case of sulfate-reducing bacteria.At other times,chemicalmethods that measure the rates of appearance of metabolicderivatives,the utilization of contaminated product compo-nents or genetic profile of the microbial population might beindicated.In evaluating non-culture tests,it is possible that theuse of these alternative standard procedures might be the onlymeans available for establishing correlation.In such cases,thisguide can serve as a reference for those considerations.1.4 Because there are so many types of tests that could beconsidered non-culture based,it is impossible to recommend aspecific test protocol with statistical analyses for evaluating thetests.Instead,this guide should assist in determining whattypes of tests should be considered to verify the utility andidentify the limitations of the nonconventional test.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD4012 Test Method forAdenosine Triphosphate(ATP)Con-tent of Microorganisms in WaterD5245 Practice for Cleaning Laboratory Glassware,Plasticware,and Equipment Used in MicrobiologicalAnalysesD5465 Practice for Determining Microbial Colony Countsfrom Waters Analyzed by Plating MethodsE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE1601 Practice for Conducting an Interlaboratory Study toEvaluate the Performance of an Analytical MethodE2756 Terminology Relating to Antimicrobial and AntiviralAgents3.Terminology3.1 Defintions:3.1.1 For definitions of terms used in this guide refer toTerminologies D1129,E2756,and E177.3.2 Abbreviations:3.2.1 HPCHeterotrophic Plate Count1This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,Antimicrobials,and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2015.Published November 2015.Originallyapproved in 1990.Last previous edition approved in 2015 as E1326 15.DOI:10.1520/E1326-15A.2The boldface numbers in parentheses refer to the list of references at the end ofthis guide.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Summary of Guide4.1 ASTM standard methods and practices are referencedfor use by producers and users in order to determine thepotential utility of a non-standard,non-culture test.4.2 Recognizing that potential users of non-culture testmethods might not have the resources with which or capabili-ties for evaluating the utility of non-standard,non-culture testmethods,recommendations