FDA认可使用的检测系统和试剂盒

1、FDA认可使用的检测系统和试剂盒 美国FDA认可使用的检测系统和试剂盒详见下列表格：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 Vitek Hazelwood,MOHoffmann LaRoche Nutley, NJHoffmann LaRoche Nutley, NJOrganon Teknika Durham, NCBecton DickinsonCockeysville, MD李斯特氏菌Micro-

2、IDcAPI LidteriaOrganon Teknika Durham, NCBioMerieux Vitek Hazelwood, 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Automicrobic GNIa,GPIb Biochemical tests 生化试验 BioMerieux Vitek Hazelwood, MO Bactometer Conductance 电导率 BioMerieux Vitek Hazelwood, MO ATB Carbon assimila

3、tion碳源利用 BioMerieux Vitek Hazelwood, MO VIDAS Automated EIAc 自动酶联 BioMerieux Vitek Hazelwood, MO MIS Fatty acid profile脂肪酸指纹 Microbial ID Newark, DE Maalthusd Conductance电导率 Radiometer America Westlake, OH Sensititre Fluorogenic dnzyme Reactions Radiometer America Westlake, OH Biolog Carbon utilizat

4、ion碳利用率 BiologHayward, CA WalkAway Biochemical生化 Baxter DiagnosticsW. Sacramento, CA AutoSCAN Biochemical生化 Baxter DiagnosticsW. acramento, CA ALADIN Biochemical生化 Analytab ProductsPlainview, NY UniScept AutoReader Biochemical生化 Analytab ProductsPlainview, NY AutoSceptor Biochemical生化 Becton Dickins

5、onCockeysville, MD a：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 SNAPGENE-TRAK Non-isotopic非同位素Colorimetric比色法 Moloecular Biosystems San Diego, CAGENE-TRAK Systems Framingham, MA Escherichia Coli GENE-TRAK Colorimetric比色法 GENE-TRAK Systems Framingham, MA Listeria GENE-TRAKAccuProb

6、eb Colorimetric比色法Chemiluminescent GENE-TRAK SystemsFramingham, MAGEN-PROBESan Diego, CA SalmonellaGENE-TRAKGENE-TRAK Isotopicc同位素Colorimetrica比色法 GENE-TRAK SystemsFramingham, MAGENE-TRAK SystemsFramingham, MA Staphylococcus Aureus GENE-TRAK Colorimetric 比色法 GENE-TRAK Systems Framingham, MA Yersinia

7、 EnterocoliticaGENE-TRAK Colorimetric比色法 GENE-TRAK SystemsFramingham, MA a：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 cereusDiarrheal Enterotoxin TECRA EIABCET-RPLA RPLA Bioenterprises Roseville, AustraliaUnipath (Oxod) Ogdensburg, NY CampylobacterCampyslideMeritec-camp

8、yMicroScreen LA LALARPLA Becton Dickinson Cockeysville, MDMeridian Diagnostic Cincinnati, OHMercia Diagnostics Shalrord, UK Clostridium Perfringens EnterotoxinPET-RPLA RPLA Unipath (Oxoid)Ogdensburg, NY Escherichia Coli EHECb0157:H7PetrifilmHECHEC 0157EHEC-TEKColine Immuno-blotEIALAEIADipstick-EIA 3

9、M, St. Paul, MN3M, CanadaLondon, OntarioUnipath (Oxoid)Ogdensburg, NYOrganon-TeknikaDurham, NCAMPCOR Camden, NJ LiteriaListeria-TEKTECRAc,dAssurance Listertest EIAEIAImmunobead Organon Teknika Durham, NCBioenterprises Roseville, AustraliaBioControl Systems Bothell, WA SalmonellaBactigenSpectateMicro

10、screen LALALA Wampole Labs Cranbury, NJRhone-Poulenc Glasgow, UKMercia Diagnostics Surrey, 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 LA Laboratoire Wellcome Paris, France Serobact LALA REMEL, Lenexa, KSUnipath (Oxoid)Ogdensburg, NY 1-2 Test Immuno-Diffusion BioControl Dystems Bothell, WA PATH-STIK Dips

11、tick-EIA LUMAC, Landgraaf The Netherlands Salmonella- TEKd,e EIA Organon TeknikaDurham, NC TECRAc,f EIA Bioenterprises Roseville, Australia Unique Dipstick-EIA Bioenterprises Roseville, Australia EQUATE EIA Binax, Portland, ME BacTrace EIA Kirkegaard PerryGaithersburg, MD Assurancef ELA BioControl S

12、ystemsBothell, WA 志贺氏菌 Bactigen LA Wampole Babs Cranbury, NJ Wellcolex LA Laboratoire Wellcome Paris, France 金黄色葡萄球菌 Staphylo-Slide LA Becton Dickinson Cockeysville, MD 金葡菌肠毒素 STE-RPLA RPIA Unipath (Oxoid) Ogdensburg, NY TECRAc,d EIA Bioenterprises Roseville, Australia SET-EIA EIA Toxin Technology M

13、adison, WI ELA TransiaLyon, France Vibrio CholeraeEnterotoxinVET-RPLAg RPLA Unipath (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。表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 Redigelb M

14、edium,APC RCR Scientific Goshen, TN Isogridb HGMF QA LabsSan Diego, CA Enlitenc ATP PromegaMadison, WI Petrifilmd Dry-film 3M, St. Paul, MN Cliform/E. coli Isogridb HGMF/MUG QA LabsSan Diego, CA Petrifilmd Dry-film 3M, St. Paul, MN ColiQuike MUG &ONPG Hach CompanyAmes, IA Colilertc MUG &ONPG

15、 EnvironeticsBranford, CT LST-MUGf MPN-Medium Difco, Detroit, Mi &Gibco, Grand Island, NY Colitrak MPN-MUG Biocontrol Systems Bothell, WA ColiCom-pleteb Enzymatic Biocontrol Systems Bothell, WA E. coli MUG disc MUG REMEL,Lenexa, KS Salmonella Isogridd HGMF QA LabsSan Diego, CA OSRT Medium/motility Unipath (Oxoid)Ogedensburg, NY Rambach Medium Technogram Paris,France MUCAP C8 Esterase Biolife Milano, Italy