1、Designation:E313117Standard Specification forNucleic Acid-Based Systems for Bacterial PathogenScreening of Suspicious Visible Powders1This standard is issued under the fixed designation E3131;the number immediately following the designation indicates the year oforiginal adoption or,in the case of re
2、vision,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.INTRODUCTIONEvaluation of nucleic acid-based detection systems is necessary to ensure that they can achieverequired
3、 performance metrics for the intended application.These systems should be evaluated in bothlaboratory and field settings to determine performance,including potential for false positive ornegative results,probability of detection(POD),and potential impacts of other substances on systemperformance suc
4、h as commonly encountered suspicious powders.Laboratory evaluations establish thebest-case performance for a product and also serve as a means to eliminate from consideration thoseproducts that have deficiencies or limitations before extensive cost and effort is expended for fieldtesting.Testing sho
5、uld be conducted under conditions recommended by the manufacturer.Thestatistical derivation used in this specification assumes that conditions during testing remain stable.Independent testing of biothreat or biological agent detection systems helps to establish thereliability of results and improves
6、 first-responder and supporting agencies confidence in these tools.It is important that testing requirements balance the need for proven systems with the need for aprocess that is not cost or time prohibitive and allows the evaluation of new technologies and assaysas they are developed.This is parti
7、cularly true for nucleic acid-based detection systems because newtechnologies and products continue to emerge on the market and existing assays may be revised whichnecessitates retesting.This specification describes a statistically based testing approach for evaluating the performance ofnucleic acid
8、-based detection systems.The approach ties performance of the system to a specifiedlower confidence bound(LCB)on the POD at a known confidence level(CL)(see Fig.1).Testing shall be conducted to one of two performance levels(see Figs.2 and 3):(1)95%PODwith 95%CL,or(2)90%POD with 90%CL.Four testing mo
9、dules shall be used to evaluatesystem performance(see Table 1):(1)Test Module 1Biological agent nucleic acid inclusivitytesting;(2)Test Module 2Biological agent nucleic acid exclusivity testing;(3)Test Module3Suspicious powder testing(commonly encountered hoax powders and environmental material that
10、could interfere with test results,controls,or cause a false positive result);and(4)Test Module4Whole organism biological agent spiked suspicious powder testing(impact of other material on theability to detect target biological agents or cause a false negative result).See Table 2 for a listing ofsusp
11、icious powders and the Annexes for the representative biological agents that shall be tested.Three different testing tiers are also defined to reduce testing burden by allowing testing ofbiological agent strain panels with fewer panel members(see Table 1).Inclusivity and exclusivitytesting tier pane
12、ls are provided in Annex A4 and Annex A5.All three testing tiers shall test the fullpanel of suspicious powders(Table 2)and the whole representative biological agent(see Annex A7)spiked into powders.While the greatest extensiveness of test panel inclusivity and exclusivity strains and highest PODand
13、 CL are always desirable,time and budget constraints often do not permit this extent of testing.While some detection systems may not be able to achieve the highest performance metrics,it is stillvaluable to know the level to which they can perform.Copyright ASTM International,100 Barr Harbor Drive,P
14、O Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by t
15、he World Trade Organization Technical Barriers to Trade(TBT)Committee.1 1.Scope1.1 General:1.1.1 Thisspecificationprovidessystemdesigners,manufacturers,integrators,procurement personnel,end users/practitioners,and responsible authorities a common set ofparameters to match the capabilities of biologi
16、cal assessmenttools with user needs.1.1.2 This specification is not meant to provide for all uses.Manufacturers,purchasers,and end users will need to deter-mine specific requirements including,but not limited to,use byhazardous material(HAZMAT)teams and Urban Search andRescue(US&R)teams,use in explosive or other hazardousenvironments or atmospheres,use with personal protectiveequipment(PPE),use by firefighters or law enforcementofficers or both,special electromagnetic compatibility needs,extende