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化妆品MicrobialTestingofCellTherapyProductsSummaryofNIHClinicalCenterStudiesElizabethReadMDChief,CellProcessingSectionDepartmentofTransfusionMedicineNIHClinicalCenterBethesda,MD6/16/06

StudyDesignGoalsSeededStudyParallelStudyCFRvsBacT/AlertvsBactecCFRvsBacT/AlertCFRvsBactecUsingmockMNCproducts,demonstratethatautomatedculturemethodsareUsingactualcelltherapyproducts,compareuseofautomatedculturemethodswithequivalenttoCFRmethodCFRmethodKhuuetal.Cytotherapy2004;6:183-195Khuuetat.Transfusion2006,inpress

SeededStudy:Design?Goal:Evaluateorganismdetectionandtimetodetection?Mockmononuclearcellproductsfromleukapheresis?6commonlyusedproductmedia–Citratedautologousplasma–PlasmaLyteA+HSA–Freezemix(DMSO/Pentastarch)–RPMI1640–X-VIVO20(containsgentamycin)–RPMI1640w/multipleantibiotics?Eachsampleseededwith10and50CFUof10differentorganisms?CFRvsBacT/AlertvsBactec

BothBacT/AlertandBactecweresuperiortoCFRinoverallorganismdetectionN=6x3x2=36;exceptAN,n=28

CFR/USPBothBacT/AlertandBactecweresuperiortoCFRintimetodetectionEvenforinoculaBacT/Alertof10CFU,timetodetectionwas7daysforbothBacT/AlertandBactec(butnotforCFR)Bactec

MultipleantibioticsinproductmediumimpaireddetectionoforganismsinallsystemsN=10x3x2=60

Inmediumwithmultipleantibiotics,impaireddetectionwasvariablefromoneorganismtothenextNoGrowthSA,YE,BS,ANNoGrowthSA,ML,BS,PB

ParallelStudy:Design?Goal:evaluatefieldperformance,falsepositives(trueposevaluationisbestdonebyseededstudy)?Testedinprocessandfinalproductsamplesfromrealcelltherapyproducts?Timeframes–12/1/02-5/16/04?BacT/AlertvsCFR–5/17/04–12/31/05?BactecvsCFR1125samples492samples

Definitionofpositiveresults?Positiveresultsexpressedas–Truepositive=detectionbysystem+confirmationbygramstainand/orsubculture–Falsepositive=detectionbysystem,butcoul