FDA认可使用的检测系统和试剂盒.doc

FDA认可使用的检测系统和试剂盒表1：检测和鉴定食源性病原菌的微量生化复合试剂盒微生物检测系统名称生产商肠杆菌科API-20EaEnterotube IIaCobas IDAMicro-IDbEnterobac-Teriaceae IIaBioMerieux VitekHazelwood,MOHoffmann LaRocheNutley, NJHoffmann LaRocheNutley, NJOrganon TeknikaDurham, NCBecton DickinsonCockeysville, MD李斯特氏菌Micro-IDcAPI LidteriaOrganon TeknikaDurham, NCBioMerieux VitekHazelwood, MOa：采纳为官方最终方法，仅用于沙门氏菌检测。b：采纳为官方最终方法，适用于所有肠杆菌。c：采纳为官方初始方法。表2微生物自动鉴定商品名称分析手段生产商AutomicrobicGNIa,GPIbBiochemical tests生化试验BioMerieux VitekHazelwood, MOBactometerConductance电导率BioMerieux VitekHazelwood, MOATBCarbon assimilation碳源利用BioMerieux VitekHazelwood, MOVIDASAutomated EIAc自动酶联BioMerieux VitekHazelwood, MOMISFatty acid profile脂肪酸指纹Microbial IDNewark, DEMaalthusdConductance电导率Radiometer AmericaWestlake, OHSensititreFluorogenic dnzymeReactionsRadiometer AmericaWestlake, OHBiologCarbon utilization碳利用率BiologHayward, CAWalkAwayBiochemical生化Baxter DiagnosticsW. Sacramento, CAAutoSCANBiochemical生化Baxter DiagnosticsW. Sacramento, CAALADINBiochemical生化Analytab ProductsPlainview, NYUniSceptAutoReaderBiochemical生化Analytab ProductsPlainview, NYAutoSceptorBiochemical生化Becton DickinsonCockeysville, MDa：食品中沙门氏菌自动检测系统；AOAC采纳为初始方法。表3核酸杂交分析微生物商品名称检测手段生产厂商Campylobacter弯曲杆菌SNAPGENE-TRAKNon-isotopic非同位素Colorimetric比色法Moloecular BiosystemsSan Diego, CAGENE-TRAK SystemsFramingham, MAEscherichiaColi艾氏大肠杆菌GENE-TRAKColorimetric比色法GENE-TRAK SystemsFramingham, MAListeria李斯特氏菌GENE-TRAKAccuProbebColorimetric比色法Chemiluminescent化学发光法GENE-TRAK SystemsFramingham, MAGEN-PROBESan Diego, CASalmonella沙门氏菌GENE-TRAKGENE-TRAKIsotopicc同位素Colorimetrica比色法GENE-TRAK SystemsFramingham, MAGENE-TRAK SystemsFramingham, MAStaphylococcusAureus金黄色葡萄球菌GENE-TRAKColorimetric比色法GENE-TRAK SystemsFramingham, MAYersiniaEnterocolitica肠炎耶尔森氏菌GENE-TRAKColorimetric比色法GENE-TRAK SystemsFramingham, MAa：AOAC地位：采纳为初始方法。b：用纯培养物鉴定。c：AOAC地位：采纳为最终方法。表4免疫分析微生物毒素商品名称分析手段生产商Bacillus cereusDiarrhealEnterotoxin蜡样芽肠肝菌股泻毒素TECRA EIABCET-RPLARPLABioenterprisesRoseville, AustraliaUnipath (Oxod)Ogdensburg, NYCampylobacter弯曲肝菌CampyslideMeritec-campyMicroScreen LALALARPLABecton DickinsonCockeysville, MDMeridian DiagnosticCincinnati, OHMercia DiagnosticsShalrord, UKClostridiumPerfringensEnterotoxin产气荚膜梭菌肠毒素PET-RPLARPLAUnipath (Oxoid)Ogdensburg, NYEscherichiaColi EHECb0157:H7出血性0157：H7大肠肝菌PetrifilmHECHEC 0157EHEC-TEKColineImmuno-blotEIALAEIADipstick-EIA3M, St. Paul, MN3M, CanadaLondon, OntarioUnipath (Oxoid)Ogdensburg, NYOrganon-TeknikaDurham, NCAMPCORCamden, NJLiteria李斯特氏菌Listeria-TEKTECRAc,dAssuranceListertestEIAEIAImmunobeadOrganon TeknikaDurham, NCBioenterprisesRoseville, AustraliaBioControl SystemsBothell, WASalmonella沙门氏菌BactigenSpectateMicroscreenLALALAWampole LabsCranbury, NJRhone-PoulencGlasgow, UKMercia DiagnosticsSurrey, UK表4免疫分析（续表）微生物毒素商品名称分析手段生产商Wellcolex LALaboratoire WellcomeParis, FranceSerobactLALAREMEL, Lenexa, KSUnipath (Oxoid)Ogdensburg, NY1-2 TestImmuno-DiffusionBioControl DystemsBothell, WAPATH-STIKDipstick-EIALUMAC, LandgraafThe NetherlandsSalmonella-TEKd,eEIAOrganon TeknikaDurham, NCTECRAc,fEIABioenterprisesRoseville, AustraliaUniqueDipstick-EIABioenterprisesRoseville, AustraliaEQUATEEIABinax, Portland, MEBacTraceEIAKirkegaard PerryGaithersburg, MDAssurancefELABioControl SystemsBothell, WA志贺氏菌BactigenLAWampole BabsCranbury, NJWellcolexLALaboratoire WellcomeParis, France金黄色葡萄球菌Staphylo-SlideLABecton DickinsonCockeysville, MD金黄色葡萄球菌肠毒素STE-RPLARPIAUnipath (Oxoid)Ogdensburg, NYTECRAc,dEIABioenterprisesRoseville, AustraliaSET-EIAEIAToxin TechnologyMadison, WIELATransiaLyon, FranceVibrioCholeraeEnterotoxin霉肠肝菌肠毒素VET-RPLAgRPLAUnipath (Oxois)Ogdensburg, NYa：缩写：EIA酶免疫分析；RPLA，反相被动乳胶凝集。LA，乳胶凝集。b：溶血性大肠肝菌。c：也适用于Biopro。d：AOAC地位：采纳为初始方法。e：两种不同增强酸免疫分析的方法：检测所有食品或低水份食品中的沙门氏菌。f：AOAC地位：采纳为最终方法。g：也可检测大肠肝菌耐热毒素。5其它商品化快速检测方法和培养基微生物商品名称分析手段生产商Bacteria细菌RedigelbMedium,APCRCR ScientificGoshen, TNIsogridbHGMFQA LabsSan Diego, CAEnlitencATPPromegaMadison, WIPetrifilmdDry-film3M, St. Paul, MNCliform/大肠菌群E. coli埃希氏大肠杆菌IsogridbHGMF/MUGQA LabsSan Diego, CAPetrifilmdDry-film3M, St. Paul, MNColiQuikeMUG &ONPGHach CompanyAmes, IAColilertcMUG &ONPGEnvironeticsBranford, CTLST-MUGfMPN-MediumDifco, Detroit, Mi &Gibco, Grand Island, NYColitrakMPN-MUGBiocontrol SystemsBothell, WAColiCom-pletebEnzymaticBiocontrol SystemsBothell, WAE. coli大肠肝菌MUG discMUGREMEL,Lenexa, KSSalmonella沙门氏菌IsogriddHGMFQA LabsSan Diego, CAOSRTMedium/motilityUnipath (Oxoid)Ogedensburg, NYRambachMediumTechnogramParis,FranceMUCAPC8EsteraseBiolifeMilano, ItalyXLT-4Mediu