5.01 2016-06-16T10:00:47 True 0 6 Text False True False AnalyticalMeth Detection and quantification analytical method unacc BAD acc good v-good exc GOOD 000000112201234 FitForPurpose Is method fit for purpose? no BAD partly yes GOOD 000011012 PurposeFitness Fitness with respect to purpose no BAD partly yes GOOD 000111222012012012 Purpose Primary purpose of analysis: screening or quantification NONE screening quantification FitForScreening Method fitness for screening no BAD partly yes GOOD 000000000001012022 Specificity Is method specific? no BAD yes GOOD LOD Limit of detection high BAD med low GOOD Robustness Is method robust? low BAD med high GOOD FitForQuantification Method fitness for quantification no BAD partly yes GOOD 000012012 FitForScreening Method fitness for screening no BAD partly yes GOOD QuantitativePerformance Method performance for quantification unacc BAD acc good GOOD SiteFitness Fitness with respect to on/off-site applicability no BAD partly yes GOOD 222012 Site Site of performing analysis: lab or on-site NONE lab on-site FitForOnSiteScreening Method fitness for on-site detection no BAD partly yes GOOD 000012 OnSiteDetection Is method suitable for on-site detection? no BAD yes GOOD FitForScreening Method fitness for screening no BAD partly yes GOOD BestForPurpose Best-for-purpose method evaluation unacc BAD acc good v-good exc GOOD 000000011201234 Constraints Constraints for best-for-purpose method no BAD partly yes GOOD 000000110022 FitForPurpose Is method fit for purpose? no BAD partly yes GOOD MethDeveloped Completeness of method development proof BAD partly almost fully GOOD 000111112223 Developed Stage of method development, cost-related proof BAD partly almost fully GOOD 00001111111222222223 DevelopementStage Current state of method development proof BAD opt.assay tested prevalidation validation GOOD SOP Is Standard Operating Procedure available? no BAD yes GOOD SuggestedSamples Are samples for method development available? no BAD yes GOOD SpecificCharacteristics Additional characteristics of method development (non cost-related) no BAD partly yes GOOD 01111212 SpecificityAssessed To which extent was method specificity assessed? no BAD partly yes GOOD not-required GOOD Proficiency Was method tested on proficiency samples? no BAD yes GOOD MethEvaluation Best for purpose method evaluation unacc BAD acc good v-good exc GOOD 0000000000000000011101121112112201121222122312331223223322342344 MethPerformance Performance of the method unacc BAD acc good exc GOOD 00001111222233330123012301230123 MethodType Method type: DNA extraction, detection or quantification NONE detection quantification MethPerformance_Detection Performance of detection method unacc BAD acc good exc GOOD 000000000000000000000000000000012012011022023012022033 Specificity Is method specific? no BAD yes GOOD LOD Limit of detection high BAD med low GOOD 001011112 False LOD_Abs Absolute limit of detection: Targets detected in single reactions insensitive BAD med good GOOD LOD_Rel Relative limit of detection: Lowest detected percentage of GMO in the sample insensitive BAD med good GOOD Robustness Is method robust? low BAD med high GOOD InhibitorHandling Sensitivity to inhibitors none BAD med good GOOD MethPerformance_Quantification Performance of quantification method unacc BAD acc good exc GOOD 000012013013 MethPerformance_Detection Performance of detection method unacc BAD acc good exc GOOD QuantitativePerformance Method performance for quantification unacc BAD acc good GOOD 000112122 Accuracy How accurate is method? low BAD med high GOOD DynamicRange Range of target copies suitable for quantification low BAD med high GOOD 000011012 LOQ Limit of quantification high BAD med low GOOD 000011022 LOQ_Low Low target LOQ high BAD med low GOOD 001011122 LOQ_Abs Absolute limit of quantification: Targets quantified in single reactions bad BAD med good GOOD LOQ_Rel Relative limit of quantification: Lowest quantifiable percentage of GMO in sample bad BAD med good GOOD LOQ_High High target LOQ low BAD med high GOOD 012 LOQ_Abs Absolute limit of quantification: Targets quantified in single reactions bad BAD med good GOOD Linearity How linear is method within range of quantification? low BAD med high GOOD MethApplicability General applicability of method bad BAD acc good exc GOOD 0123 MethApplicabilityDetection General applicability of detection method bad BAD acc good exc GOOD 0012012212232233 SampleProcessing Method applicability for sample processing bad BAD acc good exc GOOD 001123233 SampleTypes Ability of method to handle different sample types bad BAD acc good GOOD 0112 MixedSamples Does method handle mixed samples? no BAD yes GOOD ProcessedSamples Does method handle processed samples? no BAD yes GOOD RequiredAmount Required amount of sample (for DNAEx) or DNA (for detection) high BAD med low GOOD MethFunctions Extent of method functions for detection bad BAD acc good exc GOOD 0000000013332333133323332333333313332333233333332333233323333333 Screening Is method useful for screening? no BAD yes GOOD Identification Is method useful for identification? no BAD yes GOOD SpeciesDetection Is method useful for species detection? no BAD yes GOOD Quantification Is method useful for quantification? no BAD yes GOOD UnauthorisedGM Can method detect un-authorised GMOs? no BAD yes GOOD OnSiteDetection Is method suitable for on-site detection? no BAD yes GOOD Costs Method implementation costs v-high BAD high med low GOOD 0011111212221233 RunningCosts Running costs of method operation v-high BAD high med low GOOD 001012112233 Efficiency Method efficiency low BAD med high GOOD v-high GOOD 001101120122011211122233112211232333 Consumables/Sample Costs of conumables per sample high BAD med low GOOD Samples/Day Number of samples that can be analysed in one working day low BAD med high GOOD Targets/Method Number of targets that can be detected simultaneously low 1 BAD med 2-5 high 6-15 v-high >=16 GOOD PersonalCosts Costs of labour per sample high BAD med low GOOD FixedCosts Fixed costs of method implementation v-high BAD high med low GOOD 001112122233 False MaterialCosts Fixed material costs v-high BAD high range of qPCR med range of conv. PCR low basic lab or even on-site GOOD 012122222233 EquipmentCosts Costs of required equipment v-high additional equipment besides qPCR BAD high range of qPCR med range of conv. PCR low basic lab or even on-site GOOD InfrastructureCosts Cost of infrastructure high BAD med low GOOD NonMaterialCosts Fixed non-material costs high BAD med low GOOD 001111122 CompetenceCosts Personal competence required for method high BAD med low GOOD ValidationCosts Cost of in-house validation (implementation in the lab) high BAD med low GOOD