用戶手冊(cè)中英文產(chǎn)品信息userproduct informationzh

27712 Cheminde RCSLYON673620 Fax33(0)4788720,I00RS,NCservice,altion,ormodificationoftheInstrumentbyany otherthantheauthorizedTHEWARRANTYOFBIOMéRIEUXSETFORTHABOVEANDTHEOBLIGATIONSANDLIABILITIESOFBIOMéRIEUXTHEREUNDERAREEXCLUSIVEANDINLIEUOFALLOTHERREMEDIES,WARRANTIES,GUARANTEESORLIABILITIES,EXPRESSEDORIMPLIED,ARISINGBYLAWOROTHERWISE,WITHRESPECTTOANYPRODUCTSDELIVEREDHEREUNDER(INCLUDINGWITHOUTLIMITATIONANYOBLIGATIONOFBIOMéRIEUXWITHRESPECTTOMERCHANTABILITY,FITNESSFORAPARTICULARPURPOSE,NON-INFRINGEMENT,ANDWHETHERORNOTOCCASIONEDBYBIOMéRIEUX’SNEGLIGENCE).ThisWarrantyshallnotbeextendedoralteredexceptbywrittenagreementStandardWarrantytoincreasethelevelofcoverageandaddadditionalfeatures,assetforthTheEnhancedWarrantyprovidesthefollowingadditionalWarrantyPeriodServices:(i)daysaweek(hereinafterthe“EnhancedWarrantyPeriodServices”).TheseEnhancedWarrantyPeriodServicesincludeone(1)PreventiveMaintenanceservice.ExceptassameBaseWarrantytermsandconditionsassetforthabove.ANC產(chǎn)品信 預(yù)期用 1描 1注意事 1 2準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 4 4 質(zhì)量控 5認(rèn)證..................................................................................................................................1- 6ANC質(zhì)量控制 6 7局限 7性能特 7ANC卡鑒定的細(xì) 8ANC反應(yīng)孔內(nèi)容 10ANC補(bǔ)充試 11 14參考文 15BCL產(chǎn)品信 用 1描 1注意事 1 1準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 4 5 質(zhì)量控 5認(rèn)證..................................................................................................................................2- 6BCL質(zhì)量控制 7 7局限 7性能特 7BCL卡鑒定的細(xì) 7BCL反應(yīng)孔內(nèi)容 9BCL補(bǔ)充試 11 14參考文 15CBC產(chǎn)品信 用 1描 1注意事 1 2樣品準(zhǔn) 2材 2操作步 2結(jié) 3 4 4 質(zhì)量控 5認(rèn)證..................................................................................................................................3- 6CBC質(zhì)量控制 6 7局限 7性能特 7CBC卡鑒定的細(xì) 7CBC反應(yīng)孔內(nèi)容 9CBC補(bǔ)充試 10 15參考文 15GN產(chǎn)品信 用 1描 1注意事 1 2準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 5 6 質(zhì)量控 7認(rèn)證..................................................................................................................................4- 8GN質(zhì)量控制 8 9局限 9性能特 9GN卡鑒定的細(xì) 10GN反應(yīng)孔內(nèi)容 14GN補(bǔ)充試 15 19參考文 20GP產(chǎn)品信 用 1描 1注意事 1 2準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 4 4 質(zhì)量控 5認(rèn)證..................................................................................................................................5- 6GP質(zhì)量控制 6 7局限 7性能特 7GP卡鑒定的細(xì) 8GP反應(yīng)孔內(nèi)容 11GP補(bǔ)充試 12 16參考文 17NH產(chǎn)品信 用 1描 1注意事 1 2準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 3 4 質(zhì)量控 5認(rèn)證..................................................................................................................................6- 5NH質(zhì)量控制 6 6局限 6性能特 6NH卡鑒定的細(xì) 6NH反應(yīng)孔內(nèi)容 7NH補(bǔ)充試 8 10參考文 12YST產(chǎn)品信 用 1描 1注意事 1 2準(zhǔn)備標(biāo) 2材 2操作步 2結(jié) 3 4 5 質(zhì)量控 6認(rèn)證..................................................................................................................................7- 7YST質(zhì)量控制 7 8局限 8性能特 8YST卡鑒定的酵母 8YST反應(yīng)孔內(nèi)容 9YST補(bǔ)充試 11 13參考文 14 用 1試驗(yàn)概 1 試驗(yàn)原 2試 3 注意事 3 3儀 3準(zhǔn)備標(biāo) 4操作步 4 質(zhì)量控 5 結(jié) 6 局限 7預(yù)期 8性能特 8 9 15參考文 17 描 1ANC質(zhì)量控 1 ANC質(zhì)量控制 2BCL質(zhì)量控 4 BCL質(zhì)量控制 5CBC質(zhì)量控 10 CBC質(zhì)量控制 11GN質(zhì)量控 15 GN質(zhì)量控制 16GP質(zhì)量控 20 GP質(zhì)量控制 20NH質(zhì)量控 24 NH質(zhì)量控制 24YST質(zhì)量控 27 YST質(zhì)量控制 28參考文 33 VITEK?2 1VITEK?2BCL（只限工業(yè)使用 1VITEK?2CBC（只限工業(yè)使用 1VITEK?2 1VITEK?2 1VITEK?2 2VITEK?2 2VITEK?2 2VITEK?2鑒定卡選擇指 1ANCVITEK?2（ANC）VITEK?2Systems一起使用，以便自動(dòng)鑒定大多數(shù)具有臨床意義的厭氧菌和棒狀桿菌。VITEK?2ANC鑒定卡只供使用。欲了解可鑒定的細(xì)菌種類列表，請(qǐng)參見ANC卡鑒定的細(xì)菌。

VITEK?2DensiCHEK?Plus上的適當(dāng)區(qū)內(nèi)， VITEK?260VITEK?2XL：補(bǔ)充試驗(yàn)。（請(qǐng)參見ANC補(bǔ)充試驗(yàn)。） ANC產(chǎn)品信收到時(shí)，VITEK?2ANC2°C8°C

VITEK?2ANCVITEK?2DensiCHEK?PlusDensiCHEK?PlusVITEK?2無菌鹽水（0.450.50%NaCl溶液，pH4.512mmx75mm透明塑料（聚苯乙烯）試預(yù)裝鹽水的試管（0.450.50%NaCI溶液，pH4.5

以無菌方法，3.0mL無菌鹽水（0.45%0.50NaCl溶液，pH4.57.0）明的塑料（聚苯乙烯）(12mmx75mm）VITEK?2DensiCHEK?PlusMcFarlandNo2.703.30 ANC產(chǎn)品信除卡片中包括的內(nèi)部測試外，ANC鑒定算法還需要三個(gè)機(jī)外試驗(yàn)。ANCID產(chǎn)品選用的機(jī)外試驗(yàn)包括染色、形態(tài)和耐氧試驗(yàn)。ANC機(jī)外試驗(yàn)結(jié)果可被輸入至SmartCarrierStation–+?–+?––+?–+?–+?

VITEK?2Systems根據(jù)所分析細(xì)菌和反應(yīng)的數(shù)據(jù)和知識(shí)等方法鑒定細(xì)菌菌。已針對(duì)已知菌株收集2:ANCANC梭菌 ANC產(chǎn)品信Excellent（極好196VeryGood（非常好193Good（好189Acceptable（可接受185LowDiscrimination（低2100；在根據(jù)Inconclusive（不確定或或或Unidentified0

個(gè)細(xì)菌或菌群的試驗(yàn)反應(yīng)模式和獨(dú)特反應(yīng)模式完美匹配，99。如果不是完美下，概率百分比范圍為85至99。數(shù)值越接近99，表示越接近特定菌的典型模式。100。在根據(jù)某選擇判定后，保留單項(xiàng) ANC產(chǎn)品信40：“CARDERRORMissingdata”（對(duì)于出現(xiàn)結(jié)果的情況：“Organismwithlowreactivitybiopattern—pleasecheckviability”（細(xì)菌生化譜反應(yīng)性低-請(qǐng)確認(rèn)是否為活菌）。為“Nonorlowreactivebiopattern”（無反應(yīng)或低反應(yīng)生化譜）。

VITEK?2ANC質(zhì)量控制表中。根據(jù)本文件中規(guī)定的試驗(yàn)菌株操作質(zhì)量控制。（請(qǐng)參見ANC質(zhì)量控制表了解詳情。）茲此證明，bioMérieuxISO13485FDA質(zhì)量體系規(guī)范（QSR）關(guān)于微生物鑒定系統(tǒng)設(shè)計(jì)、

定方法，并聯(lián)系bioMérieux。37°C溫度孵育。孵育18至24小時(shí)，或直至有足夠的細(xì)菌生長為止。 ANC產(chǎn)品信度孵育。孵育18至24小時(shí)。2°C8°C于QC?！猀C之前，CBA因?yàn)椴缓菀自跅l件下降解的底物，可以通過試驗(yàn)兩個(gè)菌株實(shí)施常用質(zhì)量控制：在ANC上，一個(gè)在大多數(shù)情況是陽性，另外一個(gè)在大多數(shù)情況是。（請(qǐng)參見ANC質(zhì)量控制表了解詳情。 ANC產(chǎn)品信鑒定質(zhì)量控制細(xì)菌時(shí)，ANC卡的結(jié)果通常是單選，或在低分辨率或相似細(xì)菌鑒定結(jié)果內(nèi)。但是根---+--+---v-------+-------+----v-v-----表6:QC細(xì)菌：卵形擬桿菌ATCC?BAA-1296?++v++v---v+++-++++v+--+vv-v-+--v1+-+vvvv

參閱本手冊(cè)的性能特征章節(jié)，VITEK?2ANCANC反應(yīng)孔內(nèi)容 ANC產(chǎn)品信*AOACResearchInstitute40.350.02360.0370.02680.0230.0180.30.02790.030.30.18750.30.0060.150.0060.0060.03240.0060.030.02250.03420.0060.0060.03420.0240.0150.3生有色或熒光產(chǎn)物，Kovacs、Ehrlichs和DMAC試劑等）顯色。α-毒素的卵9養(yǎng)基呈堿性，pH試劑pH試劑（例如，酚紅7,8,9,15,16, ANC產(chǎn)品信VITEK?2.7035°CMcFarlandCO2厭氧菌35°CCDC3N/ACDCPEAPEACDCPEA=含5%羊血的苯乙基乙醇瓊脂TSAB=含5%羊血的胰酶大豆瓊脂TSAHB=含5%馬血的胰酶大豆瓊脂

ManualofClinicalMicrobiology,5thed.AmericanSocietyforMicrobiology,Washington,Prokaryotes-aHandbookontheBiologyofBacteria:Exophysiology,Isolation,ThreetheFirmicutes,SpringerPublishingDordrecht,2009.DifcoManualDehydratedCultureMediaandReagentsforMicrobiology.10thed.BlacksburgVA.:VPIAnaerobeLaboratory,1977.Bergey'sManualofDeterminativeBacteriology,9thed.WilliamsandWilkins,PublishingBelmontCalifornia.1992.ColorAtlasandTextbookofDiagnosticMicrobiology,4thed.LippincottPublishing,Philadelphia,PA.ColorAtlasandTextbookofDiagnosticMicrobiology,5thed.1997Lippincott,Philadelphia,NewYork.9thed.WilliamsandWilkins,Baltimore.Manafi,M.,W.Kneifel,andS. usedinbacterialdiagnostics.Microbiol.Rev.55:335-348.ManualofClinicalMicrobiology,7thed.AmericanSocietyforMicrobiology,Washington,ManualofClinicalMicrobiology,8thed.AmericanSocietyforMicrobiology,Washington,ClinicalMicrobiology.9thed.WashingtonD.C.:ASMPress,2007.WorkersfromInstrumentBiohazardsandInfectiousDiseaseTransmittedbyBlood,BodyFluidsandTissue-ApprovedGuideline,1997.U.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforDiseaseControlandPrevention,NationalInstitutesofHealth,OfficeofHealthandSafety,BiosafetyinMicrobiologicalandBiomedicalLaboratories,1988.Winn,W.C.Jr,Allen,S.D.,Janda,W.M.,Koneman,E.W.,Propcop,G.W.,Schreckenberger,P.C.,Woods,G.L.Koneman'sColorAtlasandTextbookofDiagnosticMicrobiology6thed.Philadelphia:LippincottWilliams&Wilkins,2006.2BCLVITEK?2Systems芽孢桿菌鑒定卡（BCL）僅適用于工業(yè)使用。不得用于臨床。VITEK?2BCL鑒定卡適合于與VITEK?2Systems一起使用，以便自動(dòng)化鑒定芽孢桿菌屬的需氧芽孢細(xì)菌。VITEK?2BCL鑒定卡只供使用欲了解可鑒定的細(xì)菌種類，請(qǐng)參見BCL卡鑒定的細(xì)菌。 、、13、14、16）并采用新開發(fā)的底物。共有

VITEK?2DensiCHEK?Plus上的適當(dāng)區(qū)內(nèi)，補(bǔ)充試驗(yàn)。（請(qǐng)參見BCL補(bǔ)充試驗(yàn)。） BCL產(chǎn)品信收到時(shí)，VITEK?2BCL卡放在原包裝袋內(nèi)密閉，2°C8°C

VITEK?2BCLVITEK?2DensiCHEK?PlusDensiCHEK?PlusVITEK?2無菌鹽水（0.450.50%NaCl溶液，pH4.512mmx75mm透明塑料（聚苯乙烯）試預(yù)裝鹽水的試管（0.450.50%NaCI溶液，pH4.5

以無菌方法，3.0mL無菌鹽水（0.45%0.50NaCl溶液，pH4.57.0）明的塑料（聚苯乙烯）(12mmx75mm）VITEK?2DensiCHEK?PlusMcFarlandNo1.802.20 BCL產(chǎn)品信

VITEK?2Systems根據(jù)所分析細(xì)菌和反應(yīng)的數(shù)據(jù)和知識(shí)等方法鑒定細(xì)菌菌。已針對(duì)已知菌株收集10:相似菌（混合的）分類群鑒定表中的細(xì)菌屬于BCL相似細(xì)菌的分類群。 BCL產(chǎn)品信短小短芽孢桿菌/（地短芽孢桿菌解糖類芽孢桿菌/（環(huán)狀芽孢桿菌（多粘類芽孢桿菌Excellent（極好196VeryGood（非常好193Good（好189Acceptable（可接受185LowDiscrimination（低2100；在根據(jù)Inconclusive（不確定或或或Unidentified0

個(gè)細(xì)菌或菌群的試驗(yàn)反應(yīng)模式和獨(dú)特反應(yīng)模式完美匹配，99。如果不是完美下，概率百分比范圍為85至99。數(shù)值越接近99，表示越接近特定菌的典型模式。100。在根據(jù)某選擇判定后，保留單項(xiàng)BCL40：“CARDERRORMissingdata”（對(duì)于出現(xiàn)結(jié)果的情況：“Organismwithlowreactivitybiopattern—pleasecheckviability”（細(xì)菌生化譜反應(yīng)性低-請(qǐng)確認(rèn)是否為活菌）。為“Nonorlowreactivebiopattern”（無反應(yīng)或低反應(yīng)生化譜）。

VITEK?2BCL質(zhì)量控制表中，應(yīng)根據(jù)本文件中規(guī)定的試驗(yàn)菌株操作進(jìn)行質(zhì)量控制。（請(qǐng)參見BCL質(zhì)量控制表了解詳情。）茲此證明，bioMérieuxISO13485FDA質(zhì)量體系規(guī)范（QSR）關(guān)于微生物鑒定系統(tǒng)設(shè)計(jì)、

QC菌的試驗(yàn)和保 BCL產(chǎn)品信定方法，并聯(lián)系bioMérieux。

2°C8°C

5mg/LMnSO4（以促進(jìn)芽孢形成）TSA斜面并孵育，直至在顯微鏡下觀察到2°C8°CQC之前，TSA制試驗(yàn)說明對(duì)BCL卡實(shí)施質(zhì)量控制，并須符合CLSI?M50-AQualityControlforCommercialMicrobialIdentificationSystems（微生物鑒定系統(tǒng)質(zhì)量控制）規(guī)定的標(biāo)準(zhǔn)。試驗(yàn)時(shí)可采用地短芽孢桿菌ATCC?51663?評(píng)估BNAG反應(yīng)孔性能。bioMérieux,Inc試驗(yàn)證明，BNAG反應(yīng)孔是BCL卡上最不穩(wěn)定的反應(yīng)孔，地短芽孢桿菌ATCC?51663?是檢測此反應(yīng)孔出現(xiàn)降解，產(chǎn)生假 BCL質(zhì)量控制 BCL產(chǎn)品信BCL鑒定質(zhì)量控制細(xì)菌時(shí)，BCL卡的結(jié)果通常是單選，或在低分辨率或相似細(xì)菌鑒定結(jié)果內(nèi)。但是根-v--vNaCl-vvv-vvvv+---v+-vvvv+v-v-+vvv-+v-vvv+-++av

VITEK?2BCL卡不能直接用于微生物樣本或含有混合菌群的其它來源樣本。修改或變更此操作步參閱本手冊(cè)的性能特征章節(jié)，VITEK?2BCLBCLBCL卡鑒定的細(xì) BCL產(chǎn)品信*AOACResearchInstituteBCL15:BCL10.032430.022840.02450.023470.026480.023490.0360.0180.0360.02220.02820.04080.0388730.30.0360.30.01215:BCL0.0360.0360.03660.150.0320.30.3a0.2016.5NaClNaCl1.950.0060.0030.02250.01890.00093BCL16:BCL10oC20oC24,28,40°C50°C1,2,3,7,8,13,18,19,20,24,37,60-60-63°C24,20,22,24,37,38,20,24,29,36,37,19,20,22,pH試劑（例如，酚紅10,13,14,15,16,19,20,37,22,30,36,pH試劑（例如，酚紅和溴甲酚紫）顯示D-26,34,41,pH試劑（例如，酚紅和溴甲酚紫）顯示D-5,24,34,pH試劑（例如，酚紅和溴甲酚紫）顯示D-BCL18,19,20,28,pH試劑（例如，酚紅和溴甲酚紫）顯示D-1,7,8,10,13,16,18,19,20,22,16:BCLpH試劑（例如，酚紅和溴甲酚紫）顯示D-3,7,8,10,13,16,18,19,20,Egg16,18,19,20,24,1,7,8,10,12,14,16,18,19,20,24,36,pH試劑（酚紅和溴甲26,34,41,GRAM1,4,5,7,8,14,19,20,21,22,24,26,苯（如Kovac試5,7,8,11,14,19,20,36,pH試劑（酚紅和溴甲21,22,pH試劑（例如，酚紅BCL1,7,8,10,13,16,18,19,20,22,30,36,37,24,36,16:BCLNaCl2%NaClNaCl5%NaClBCL卡上，但被推薦為28,37,NaCl7%NaCl5,24,26,pH試劑（例如，酚紅和溴甲酚紫）N-BCL20,37,18,19,20,22,24,5,7,8,14,18,20,36,pHpH5pH524,36,41,pHpH6pH6pHpH9pH94,7,8,14,18,20,22,SPORE4,7,8,14,18,20,22, BCL產(chǎn)品信16:BCLSPORE4,7,8,14,18,20,22,SPORE4,7,8,14,18,20,22,36,6,24,36,養(yǎng)基呈堿性，pH試劑Voges-4,7,8,13,14,19,20,24,37,VITEK?2片AST進(jìn)行30°C至氧，1.80McFarland54°C至氧，aPDA=酸化馬鈴薯葡萄糖瓊脂KK

Albuquerque,L.,Rainey,F.A.,Chung,A.P.,Sunna,A.,Nobre,M.F.,Grote,R.,Antranikian,G.,daCosta,M.S.2000.Alicyclobacillushesperidumsp.nov.andarelatedgenomicspeciesfromsolfataricsoilsofS?oMiguelintheAzores.Int.J.Syst.Evol.Microbiol.50:2.Alexander,B&Priest,F.G.1989.Bacillusglucanolyticus,anewspeciesthatdegradesavarietyofβ-glucans.IntJSystBacteriol39,112-115.2005.Brevibacilluslevickiisp.nov.andAneurinibacillusterranovensissp.nov.,twonovelJSystBacteriol.55,1039-1050.Bergey'sManualofSystematicBacteriology,2ndedn.,Volume3.DeVos,P.,Garrity,G.,Jones,D.,Krieg,N.R.,Ludwig,W.,Rainey,F.A.,Schleifer,K.-H.,andWhitman,W.B.(eds),SpringerVerlag,NewYork,pp.269-295.P.andLogan,N.A.2010.EmendeddescriptionsofGeobacillusthermoleovoransGeobacillusthermocatenulatus.IntJSystEvolMicrobiol.61,1802-675andBacillussubtillisDSM2277asBacillusatrophaeus.Int.J.Syst.Evol.Microbiol.51:1.Gordon,R.E.,Haynes,W.C.,Pang,C.H.N.1973.ThegenusBacillus.InBrevibacillusbrevisstrainsNCIMB13288andDSM6472(=NRRLNRS-887)asAneurinibacillusdanicussp.nov.andBrevibacilluslimnophilussp.nov.IntJSystBacteriol.54,419-427.genusAlicyclobacillus.IntJSystEvolMicrobiol.53,1537-1544.Heyndrickx,M.,DeVos,P.,Lebbe,L.,Forsyth,G.,andLogan,N.A.2008.EmendeddescriptionofBacillussporothermoduransandBacillusoleronius.IntJSystEvolMicrobiol:Acceptedsubjecttochange.Microbial:55,2551-2554.Logan,N.A.,Aziz,A.M.,Ali,N.,&Berkeley,R.C.W.1996.ApolyphasicreassessmentofthegenusPaenibacillus,reclassificationofBacilluslautus(Nakamura1984)asPaenibacilluslautuscomb.nov.andofBacilluspeoriae(Montefuscoetal.1993)asPaenibacilluspeoriaecom.nov.,andemendeddescriptionsofP.lautusandofP.peoriae.IntJSystBacteriol46,988-1003.Heyrman,J.,Logan,N.A.,Rodriguez-Diaz,M.,Scheldeman,P.,Lebbe,L.,thetransferof‘Bacillusmaroccanus’and‘Bacilluscarotarum’toBacillussimplex,re-Bacillusmuralissp.nov.Int.J.Syst.Evol.Microbiol..55:1.Logan,N.A.,DeClerck,E.,Lebbe,L.,Verhelst,A.,Goris,J.,Forsyth,G.,nt.lntJSystEvolMicrobial.54:1071-system.J.Gen.Microbiol.130:1871.BacillusanthracisbyAPItests.J.Med.Microbiol.20:Logan,N.A.,andDeVos,P.2008.BacillusCohn1872.InBergey'sManualofSystematicBacteriology,2ndedn.DeVos,P.,Garrity,G.,Jones,D.,Krieg,N.R.,Verlag,NewYork.(InPress).Logan,N.A.&DeVos,P.2008.GenusBrevibacillusShida,Tagaki,KadowakiandKomagata1996b,942VP.InBergey'sManualofSystematicBacteriology,2nded.DeK.-H.,andWhitman,W.B.(eds),Springer-Verlag,NewYork.(InPress).Logan,N.A.&DeVos,P.2008.GenusGeobacillusNazina,Tourova,Poltaraus,Bergey'sManualofSystematicBacteriology,2nded.DeVos,P.,Garrity,G.,Jones,(eds),Springer-Verlag,NewYork.(InPress).Logan,N.A.,Forsyth,G.,Lebbe,L.,Goris,L.,Heyndrickx,M.,Balcaen,A.,Verhelst,A.,Falsen,E.,Ljungh,?.,Hansson,H.B.,DeVos,P.2002.PolyphasicidentificationofBacillusandBrevibacillusstrainsfromclinical,dairyandindustrialspecimensandproposalofBrevibacillusinvocatussp.nov.Int.J.Syst.Evol.Microbiol.R.Murray,E.J.Baron,M.L.Landry,J.H.Jorgensen&M.A.Pfaller.AmericanSocietyforMicrobiology,Washington,DC.Logan,N.A.,&Berkeley,R.C.W.1981.ClassificationandidentificationofmembersofthegenusBacillus.InTheAerobicEndospore-formingBacteria,pp.105-140.EditedbyLogan,N.A.,andDeVos,P.2009.Bacillus.InBergey'sManualofSystematicVerlag,NewYork,pp.21-128.Logan,N.A.&DeVos,P.2009.Brevibacillus.InBergey'sManualofSystematicVerlag,NewYork,pp.305-316.Logan,N.A.,DeVos,P.&Dinsdale,A.E.2009.Geobacillus.InBergey'sManualofSystematicBacteriology,2ndedn.,Volume3.DeVos,P.,Garrity,G.,Jones,D.,Springer-Verlag,NewYork,pp.144-160.MacFaddinJF,editor.BiochemicalTestsforIdentificationofMedicalBacteria.3rded.Philadelphia:LippincottWilliams&Wilkins;2000.p.451-453.nom.rev.IntJSystBacteriol34,224-226.coagulansHammer1915withaproposalforBacillussmithiisp.nov.Int.J.Syst.Bacteriol.38:63.andaproposalforBacillusatrophaeussp.nov.Int.J.Syst.Bacteriol.39:3.FluidsandTissue—ApprovedGuideline,1997.Bacillussonorensissp.nov.,acloserelativeofBacilluslicheniformis,isolatedfromsoilintheSonoranDesert,Arizona.Int.J.Syst.Evol.Microbiol.51:5.Syst.Bacteriol.46:759.amyloliquefacienssp.nov.nom.rev.Int.J.Syst.Bacteriol.37:69.Bacteriol.46:2.fromrawandheat-treatedmilk.IntJSystEvolMicrobiol54,885-891.Shida,O.,Takagi,H.,Kadowaki,K.,Komagata,K.1996.Proposalfortwonewgenera,Brevibacillusgen.nov.andAneurinibacillusgen.nov.Int.J.Syst.Bacteriol.46:Shida,O.,Tagaki,H.,Kadowaki,K.,Nakamura,L.K.,&Komagata,K.1997.EmendeddescriptionofPaenibacillusamylolyticusanddescriptionofPaenibacillusillinoisensissp.nov.andPaenibacilluschibensissp.nov.IntJSystBacteriol47,299-306.EvolMicrobial.52:2251-2255.U.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforBiosafetyinMicrobiologicalandBiomedicalLaboratories,1988.Comparativesequenceysesonthe16SrRNA(rDNA)ofBacillusacidocaldarius,Bacillusacidoterrestris,andBacilluscycloheptanicusandproposalforcreationofanewgenus,Alicyclobacillusgen.,nov.IntJSystBacteriol.42,263-269.Yokota,A.,Fujii,T.,Goto,K.(eds.)2007.Alicyclobacillus:ThermophilicAcidophilicBacilli.Japan:Springer.3CBC產(chǎn)品信息VITEK?2棒狀桿菌鑒定卡（CBC）僅適用于工業(yè)使用。不得用于臨床。VITEK?2棒狀桿菌鑒定卡（CBC）VITEK?2Systems一起使用，以便自動(dòng)鑒定棒狀桿菌（棒狀桿菌屬及相關(guān)菌屬）。VITEK?2CBC鑒定卡只供使用欲了解可鑒定的細(xì)菌種類，請(qǐng)參見CBC卡鑒定的

VITEK?2DensiCHEK?Plus上的適當(dāng)區(qū)內(nèi)，VITEK?260VITEK?2XL：補(bǔ)充試驗(yàn)。（請(qǐng)參見CBC補(bǔ)充試驗(yàn)。） CBC產(chǎn)品信

收到時(shí)，CBC卡放在原包裝袋內(nèi)密閉，2°C8°C

VITEK?2CBC卡是一個(gè)用于常規(guī)鑒定棒狀桿菌（棒狀桿菌菌屬及相關(guān)菌VITEK?2CBCVITEK?2DensiCHEK?PlusDensiCHEK?PlusVITEK?2無菌鹽水（0.450.50%NaCl溶液，pH4.512mmx75mm透明塑料（聚苯乙烯）試預(yù)裝鹽水的試管（0.450.50%NaCI溶液，pH4.5

以無菌方法，3.0mL無菌鹽水（0.45%0.50NaCl溶液，pH4.57.0）明的塑料（聚苯乙烯）(12mmx75mm） CBC產(chǎn)品信VITEK?2DensiCHEK?PlusMcFarlandNo2.703.30

VITEK?2Systems根據(jù)所分析細(xì)菌和反應(yīng)的數(shù)據(jù)和知識(shí)等方法鑒定細(xì)菌菌。已針對(duì)已知菌株收集這種情況?？梢圆捎醚a(bǔ)充測試區(qū)分相似菌的分類群。表18:CBC相似細(xì)菌分類群表中的細(xì)菌屬于CBC相似細(xì)菌的分類群。Excellent（極好196VeryGood（非常好193Good（好189Acceptable（可接受185 CBC產(chǎn)品信LowDiscrimination（低2100；在根據(jù)Inconclusive（不確定或或或Unidentified0

個(gè)細(xì)菌或菌群的試驗(yàn)反應(yīng)模式和獨(dú)特反應(yīng)模式完美匹配，99。如果不是完美下，概率百分比范圍為85至99。數(shù)值越接近99，表示越接近特定菌的典型模式。100。在根據(jù)某選擇判定后，保留單項(xiàng)40：“CARDERRORMissingdata”（ CBC產(chǎn)品信對(duì)于出現(xiàn)結(jié)果的情況：“Organismwithlowreactivitybiopattern—pleasecheckviability”（細(xì)菌生化譜反應(yīng)性低-請(qǐng)確認(rèn)是否為活菌）。為“Nonorlowreactivebiopattern”（無反應(yīng)或低反應(yīng)生化譜）。

量控制。（請(qǐng)參見CBC質(zhì)量控制表了解詳情。）茲此證明，bioMérieuxISO13485FDA質(zhì)量體系規(guī)范（QSR）關(guān)于微生物鑒定系統(tǒng)設(shè)計(jì)、

定方法，并聯(lián)系bioMérieux。育。孵育18至24小時(shí)，或直至有足夠的細(xì)菌生長為止。育18至24小時(shí)。

CBC產(chǎn)品信

QC之前，CBA因?yàn)椴缓跅l件下容易降解的底物，可以通過測試兩個(gè)菌株實(shí)施常用質(zhì)量控制：在CBC上，一個(gè)在大多數(shù)情況是陽性，另外一個(gè)在大多數(shù)情況是。請(qǐng)參見CBC質(zhì)量控制表。CBC鑒定質(zhì)量控制細(xì)菌時(shí)，CBC卡的結(jié)果通常是單選，或在低分辨率或相似細(xì)菌鑒定結(jié)果內(nèi)。但是根-v-v----v--v-----vv----+--vv-v--vv-vv-v-- CBC產(chǎn)品信v+v-vv+++v+vv++vvv+-+++-+-++vv+++v++-vvv-

VITEK?2CBC卡不能直接用于微生物樣本或含有混合菌群的其它來源樣本。修改或變更此操作步CBC數(shù)據(jù)庫中可能未含新發(fā)現(xiàn)的或罕見細(xì)菌菌種。在獲得這些菌株后將會(huì)加入數(shù)據(jù)庫中。試驗(yàn)不參閱本手冊(cè)的性能特征章節(jié)，VITEK?2CBCCBCCBC卡鑒定的細(xì) CBC產(chǎn)品信CBC反應(yīng)孔內(nèi)容 CBC產(chǎn)品信CBC23:CBC20.038440.350.1560.026470.1580.1590.0360.0180.150.02760.30.0360.30.18750.03240.01050.02340.01920.030.30.0540.0060.150.0360.18750.0360.00.150.0240.03420.1260.30.02250.030.3CBC24:CBC20°C10,23,32,33,40°C2,31,32,42°C12,13,26,28,2,24:CBC14,33,22,23,26,28,B-28,32,39,CAMP23,CAMP試驗(yàn)（金黃色葡萄球13,19,21,23,37,21,23,26,42,11,12,14,19,21,23,28,30,33,34,46,DNA14,16,28,34,45,某些試驗(yàn)也存在于CBC10,11,13,18,20,21,27,28,33,37,45,46,24:CBC12,13,19,20,25,32,38,39,45,28,18,19,22,23,30,32,45,46,26,用試劑（Kovacs、Ehrlichs和DMAC試劑10,11,26,30,34,39,45,46,12,17,21,23,28,34,某些試驗(yàn)也存在于CBC15,17,19,20,39,42,13,17,21,23,33,34,24:CBC11,12,14,17,19,20,28,32,34,40,NaCl5%NaCl2NaCl6.5NaCl13,23,34,10,11,14,18,20,21,26,28,33,38,45,46,10,13,17,20,22,23,26,28,31,33,37,39,45,14,23,34,39,17,18,21,23,30,32,39,42,14,17,28,33,42,45,30,34,47,24:CBC某些試驗(yàn)也存在于CBC10,11,14,16,18,19,26,28,33,37,45,46,10,12,14,21,23,25,28,31,33,34,38,39,45,某些試驗(yàn)也存在于CBC10,11,13,14,16,17,19,20,22,23,25,26,30,32,34,35,37,38,40,42,45,46, CBC產(chǎn)品信VITEK?2AST進(jìn)行稀30oC37oCCO22.70TSA=胰酶大豆瓊脂

nov.andMicrobacteriumphyllosphaeraesp.nov.,isolatedfromthephyllosphereofgrassesandthesurfacelitteraftermulchingthesward,andreclassificationofAureobacteriumresistens(Funkeetal.1998)asMicrobacteriumresistenscomb.nov.Int.Bergey’sManualofDeterminativeBacteriology1sted.(1986)pp.1476-Bergey’sManualofDeterminativeBacteriology9thed(1994)pp.592-593,589,Gordonianamibiensissp.nov.,anovelnitrilemetabolisingactinomyceterecoveredfromanAfricansand.Syst.Appl.Microbiol.24:510-515.Int.J.Syst.Bacteriol.32:315-326.Collins,M.D.,Falsen,E.,Akervall,E.,Sj?den,B.,Alvarez,A.1998.Corynebacteriumkroppenstedtiisp.nov.,anovelCorynebacteriumthatdoesnotcontainmycolicacids.Int.J.Syst.Evol.Microbiol.48:1449-1454.Collins,M.D.,Phillips,B.A.,Zanoni,P.1989.DeoxyribonucleicacidhomologystudiesofLactobacilluscasei,Lactobacillusparacaseisp.nov.,subsp.paracaseiandsubsp.tolerans,andLactobacillusrhamnosussp.nov.,comb.nov.Int.J.Syst.Bacteriol.Davis,M.J.,GillaspieJr.,A.G.,Vidaver,A.K.,Harris,R.W.1984.Clavibacter:anewgenuscontainingsomephytopathogeniccoryneformbacteria,includingClavibacterxylisubsp.xylisp.nov.,subsp.,nov.andClavibacterxylisubsp.cynodontissubsp.nov.,pathogensthatcauseratoonstuntingdiseaseofsugarcaneandBermudagrassstuntingdisease.Int.J.Syst.Bacteriol.34:107-117.Dellaglio,F.,Dicks,L.M.T.,duToit,M.,Torriani,S.1991.DesignationofATCC334inceofATCC393(NCDO161)astheneotypestrainofLactobacilluscaseisubsp.caseiandrejectionofthenameLactobacillusparacasei(Collinsetal.,1989).Int.J.Syst.Bacteriol.41:340-342.Evtushenko,L.I.,Dorofeeva,L.V.,Subbotin,S.A.,Cole,J.R.,Tiedje,J.M.2000.Leiiapoaegen.nov.,isolatedfromnematodegallsonPoeannua,andreclassificationof‘Corynebacteriumaquaticum’Lei1962asLeiiaaquatica(exLei1962)gen.nov.,nom.Rev.,comb.nov.andClavibacterxyliDavisetal1984withtwosubspeciesasLeiiaxyli(Davisetal.1984)gen.nov.,comb.nov.Int.J.Syst.Evol.Microbiol.50:371-380.Fernandez-Garayzabal,J.F.,Collins,M.D.,Hutson,R.A.,Fernandez,E.,Monasterio,R.,Marco,J.,Dominguez,L.1997.Corynebacteriummastitidissp.nov.,isolatedfrommilkofsheepwithsubclinicalmastitis.Int.J.Syst.Bacteriol.47:1082-1085.Feuer,C.,Clermont,D.,Bimet,F.,Candréa,A.,Jackson,M.,Glaser,P.,Bizet,C.,Dauga,C.2004.Taxonomiccharacterizationofninestrainsisolatedfromclinicalandenvironmentalspecimens,andproposalofCorynebacteriumtuberculostearicumsp.nov.Int.J.Syst.Evol.Microbiol.54:1055-1061.Funke,G.,Alvarez,N.,Pascual,C.,Flasen,E.,Akervall,E.,Sabbe,L.,Schouls,L.,Weiss,N.,Collins,M.D.1997.Actinomyceseuropaeussp.nov.,isolatedfromhumanclinicalspecimens.Int.J.Syst.Bacteriol.47:687-692.D.1996.IsolationofArthrobacterspp.fromclinicalspecimensanddescriptionofArthrobactercumminsiisp.nov.andArthrobacterwoluwensissp.nov.J.Clin.Microbiol.Funke,G.,Lawson,P.A.,Collins,M.D.1995.Heterogeneitywithinhuman-derivedCentersforDiseaseControlandPrevention(CDC)coryneformGroupANF-1-likebacteriaanddescriptionofCorynebacteriumaurissp.nov.Int.J.Syst.Bacteriol.45:735-739.anunusualspeciesfromhumanclinicalmaterial.Int.J.Syst.Bacteriol.47:952-957.Funke,G.,Osorio,C.R.,Frei,R.,Riegel,P.,Collins,M.D.1998.Corynebacteriumconfusumsp.nov.,isolatedfromhumanclinicalspecimens.Int.J.Syst.Bacteriol.Funke,G.,Pagano-Niederer,M.,Sj?dén,B.,Falsen,E.1998.CharacteristicsofArthrobactercumminsii,themostfrequentlyencounteredArthrobacterspeciesinhumanclinicalspecimens.J.Clin.Micro.36:1539-1543.Funke,G.,Ramos,C.P.,Collins,M.D.1997.Corynebacteriumcoyleaesp.nov.,isolatedfromhumanclinicalspecimens.Int.J.Syst.Bacteriol.47:92-96.Funke,G.,Stubbs,S.,vonGravenitz,A.,Collins,M.D.1994.Assignmentofhuman-derivedCDCGroup1coryneformbacteriaandCDCGroup1-likecoryneformbacteriatothegenusActinomycesasActinomycesneuiisubsp.neuiisp.nov.,subsp.nov.,andActinomycesneuiisubsp.anitratussubsp.nov.Int.J.Syst.Bacteriol.44:167-171.Klatte,S.,Jahnke,K.,Kroppenstadt,R.M.,Rainey,F.,Stackebrandt,E.1994.RhodococcusluteusisalatersubjectivesynonymofRhodococcusfascians.Int.J.Syst.Bacteriol.44:627-630.Klatte,S.,Kroppenstedt,R.M.,Rainey,F.A.1994.Rhodococcusopacussp.nov.,anunusualnutritionallyversatileRhodococcusspecies.Syst.Appl.Microbiol.17:355-360.Kummer,C.,Schumann,P.,Stakebrandt,E.1999.Gordoniaalkanivoranssp.nov.,isolatedfromtar-contaminatedsoil.Int.J.Syst.Evol.Microbiol.49:1513-1522.Laffineur,K.,Avesani,V.,Cornu,G.,r,J.,Janssens,M.,Wauters,G.,ClinicalMicrobiology.9thed.WashingtonD.C.:ASMPress,2007.pp.485-514.WorkersfromInstrumentBiohazardsandInfectiousDiseaseTransmittedbyBlood,BodyFluidsandTissue-ApprovedGuideline,1997.genusincludingDietziamariscomb.nov.,formerlyRhodococcusmaris.Int.J.Syst.Bacteriol.45:32-36.Rainey,F.,Burghardt,J.,Kroppenstedt,R.,Klatte,S.,Stackebrandt,E.1995.PolyphasicevidenceforthetransferofRhodococcusroseustoRhodococcusrhodochrous.Int.J.Syst.Bacteriol.45:101-103.Ramos,C.P.,Foster,G.,Collins,M.D.1997.PhylogeneticysisofthegenusActinomycesbasedon16SrRNAgenesequences:descriptionofArcanobacteriumphocaesp.nov.,Arcanobacteriumbernardiaecomb.nov.,andArcanobacteriumpyogenescomb.nov.Int.J.Syst.Bacteriol.47:46-53.Renaud,F.N.R.,Aubel,D.,Riegel,P.,Meugnier,H.,Bollet,C.2001.Corynebacteriumfreneyisp.nov.,α-glucosidase-positivestrainsrelatedtoCorynebacteriumxerosis.Int.J.Syst.Evol.Microbiol.51:1723-1728.Riegel,P.,DeBriel,D.,Prévost,G.,Jehl,F.,Monteil,H.,Minck,R.1993.TaxonomicStudyofCorynebacteriumGroupANF-1strains:proposalofCorynebacteriumafermentanssp.nov.containingthesubspeciesC.afermentanssubsp.afermentanssubsp.nov.andC.afermentanssubsp.lipophilumsubsp.nov.Int.J.Syst.Bacteriol.Monteil,H.1994.RhodococcuschubuensisTsukamura1982isalatersubjectivesynonymRiegel,P.,Ruimy,R.,Renaud,F.N.R.,Freney,J.,Prevost,G.,Jehl,F.,Christen,R.,Monteil,H.1997.Corynebacteriumsingularesp.nov.,anewspeciesforurease-positivestrainsrelatedtoCorynebacteriumminutissimum.Int.J.Syst.Bacteriol.sources.J.Clin.Microbiol.39:3955-3961.cellulans(StackebrandtandKeddie1986)asCellulosimicrobiumcellulansgen.nov.,comb.nov.Int.J.Syst.Evol.Microbiol.51:1007-1010.isolatedfrommiddleearfluid.J.Clin.Microbiol.31:1667-1668.1996.Lactobacilluscurvatussubsp.curvatussubsp.nov.andLactobacilluscurvatussubsp.melibiosussp.nov.andLactobacillussakesubsp.sakesubsp.nov.andLactobacillussakesubsp.carnosussubsp.nov.,NewSubspeciesofLactobacilluscurvatusAbo-ElnagaandKandler1965andLactobacillussakeKatagiri,Kitahara,andFukami1934(Kleinetal.1996,emendeddescriptions),respectively.Int.J.Syst.Bacteriol.46:1158-1163.U.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforBiosafetyinMicrobiologicalandBiomedicalLaboratories,1988.Wauters,G.,Avesani,V.,Laffineur,K.,r,J.,Janssens,M.,VanBosterhaut,samples.Int.J.Syst.Evol.Microbiol.53:1321-1325.Wauters,G.,Haase,G.,Avensani,V.,r,J.,Janssens,M.,VanBroeck,J.,anddescriptionofBrevibacteriumsanguinissp.nov.J.Clin.Microbiol.42:2829-2832.origin.J.Clin.Micro.36:1430-1432.Winn,W.C.,Allen,S.D.,Janda,W.M.,Koneman,E.W.,Procop,G.W.,Schreckenberger,P.C.,Woods,G.L.Koneman’sColorAtlasandTextbookof734-738,742-743,785-834.Yassin,A.F.,Steiner,U.,Ludwig,W.2002.Corynebacteriumaurimucosumsp.nov.andemendeddescriptionofCorynebacteriumminutissimumCollinsandJones(1983).Int.thegenusAureobacteriumandtransferofFlavobacteriumesromaticumOmelianskitothegenusAureobacteriumasAureobacteriumesromaticumcomb.nov.Int.J.Syst.Bacteriol.43:555-564.Microbiol.50:2173-2180.4GNVITEK?2菌鑒定卡（GN）適合于與VITEK?2Systems一起使用，以便自動(dòng)鑒定大多數(shù)具有臨床意義的發(fā)酵和非發(fā)酵桿菌。VITEK?2GN鑒定卡只供使用欲了解可鑒定的細(xì)菌種類列表，請(qǐng)參見GN卡鑒定的細(xì)菌。對(duì)照反應(yīng)孔（反應(yīng)孔52）被用做脫羧酶測試反應(yīng)孔的基線參照。獲得最終結(jié)果最多大約需要

VITEK?2DensiCHEK?Plus上的適當(dāng)區(qū)內(nèi)，VITEK?260VITEK?2XL： GN產(chǎn)品信補(bǔ)充試驗(yàn)。（請(qǐng)參見GN補(bǔ)充試驗(yàn)。） 標(biāo)本和微生物培養(yǎng)物均有潛在傳染性，處理時(shí)應(yīng)該采取通用預(yù)防措施（21,菌O157、土拉熱弗朗西菌和 收到時(shí)，VITEK?2GN2°C8°C

與VITEK?2儀器一起使用時(shí)，GN卡是一個(gè)用于常規(guī)鑒定大多數(shù)重要發(fā)酵和非發(fā)酵桿菌VITEK?2GNVITEK?2DensiCHEK?PlusDensiCHEK?PlusVITEK?2無菌鹽水（0.450.50%NaCl溶液，pH4.512mmx75mm透明塑料（聚苯乙烯）試預(yù)裝鹽水的試管（0.450.50%NaCI溶液，pH4.5

GN明的塑料（聚苯乙烯）12mmx75mm）注丟

VITEK?2Systems根據(jù)所分析細(xì)菌和反應(yīng)的數(shù)據(jù)和知識(shí)等方法鑒定細(xì)菌菌。已針對(duì)已知菌株收集這種情況。可以采用補(bǔ)充測試區(qū)分相似菌的分類群。GNGN相似 GN產(chǎn)品信洋蔥爾德菌阪崎新生兒桿菌陰溝腸桿菌溶解莫拉菌沙門菌腸沙門菌腸液化沙雷菌 GN產(chǎn)品信志賀菌菌菌菌Excellent（極好196VeryGood（非常好193Good（好189Acceptable（可接受185LowDiscrimination（2Inconclusive（不確定或或或Unidentified0

個(gè)細(xì)菌或菌群的試驗(yàn)反應(yīng)模式和獨(dú)特反應(yīng)模式完美匹配，99。如果不是完美下，概率百分比范圍為85至99。數(shù)值越接近99，表示越接近特定菌的典型模式。100。在根據(jù)某選擇判定后，保留單項(xiàng)GNGN鼻疽爾德菌類似。鑒于可能存在爾德菌，用戶應(yīng)該將此菌株送至國家衛(wèi)生或其它大菌腸沙門菌亞利桑那由由 GN菌40：“CARDERRORMissingdata”