In vitro diagnostic (IVD) tests are medical devices intended.pptx

In vitro diagnostic (IVD) tests are medical devices intended.pptx

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时间:2020-01-16

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1、Labد.حسينمحمدجمعهاختصاصيالامراضالباطنةالبوردالعربيكليةطبالموصل2011Invitrodiagnostic(IVD)testsaremedicaldevicesintendedtoperformdiagnosesfromassaysinatesttube,ormoregenerallyinacontrolledenvironmentoutsidealivingorganism.InvitromeansinglassinLatin.Inmi

2、crobiology,colony-formingunit(CFUorcfu)isameasureofviablebacterialorfungalnumbers.Unlikedirectmicroscopiccountswhereallcells,deadandliving,arecounted,CFUmeasuresviablecells.ForconveniencetheresultsaregivenasCFU/mL(colony-formingunitspermilliliter)forl

3、iquids,andCFU/g(colony-formingunitspergram)forsolids.Ameasureofviablecellsinwhichacolonyrepresentsanaggregateofcellsderivedfromasingleprogenitorcell.SupplementCFUisusedtodeterminethenumberofviablebacterialcellsinasamplepermL.Hence,ittellsthedegreeofco

4、ntaminationinsamplesofwater,vegetables,soilorfruits,orthemagnitudeoftheinfectioninhumansandanimals.Thetermefficacygenerallyreferstotheabilityofaproducttoachieveitsdesiredeffectunderidealconditions,suchasacontrolledclinicaltrialinwhichtheproductisconsi

5、stentlyadministeredasprescribed.Theeffectivenessofaproductisitsabilitytoachievethedesiredeffectunderreal-worldconditions.Thechargetothecommitteeusesbothterms,andinmanysituationsthetermsareusedinterchangeably,withthecontextshowingwhethertheeffectswereo

6、bservedunderlaboratory-controlledorreal-worldconditions.PolymeraseChainReactionvs.BloodCultureinSepsisCorrelationwithsepsisseverityparameterswasbetterforPCRthanforbloodculture;inpatientswithsepsis,concordancebetweenthetwomethodswasmodest.Inpatientswit

7、hsepsis,rapidinitiationofadequateantibiotictherapyisakeycomponentoftherapy.Empiricaltherapywithbroad-spectrumantibioticsisuseduntilthecausativepathogenisidentified.(PCR)-baseddetectionsystemscouldmarkedlyshortenthetimetopathogenidentification,thushast

8、eningthestartoftargetedantibiotictherapy.ButhowwelldosuchPCR-basedsystemsperform?Tofindout,researchersinGermany—sponsoredbyindustry—comparedresultsofawhole-bloodbacterialandfungalDNAmultiplexPCRsystemwithconventionalbloodculture(BC)in142surgic

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