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化妆品 Microbial Testing of Cell Therapy ProductsSummary of NIH Clinical Center StudiesElizabeth Read MDChief, Cell Processing Section Department of Transfusion MedicineNIH Clinical CenterBethesda, MD6/16/06Study Design Goals Seeded StudyCFRvs BacT/Alertvs BactecUsing mock MNC products,demonstrate that automated culture methods areequivalent to CFR methodKhuu et al. Cytotherapy 2004;6:183-195Parallel StudyCFR vs BacT/AlertCFR vs BactecUsing actual cell therapy products,compare use of automatedculture methods with CFR methodKhuu et at. Transfusion 2006, in pressSeeded Study: DesignGoal: Evaluate organism detection and time to detectionMock mononuclear cell products from leukapheresis6 commonly used product mediaCitrated autologous plasmaPlasmaLyte A + HSAFreeze mix (DMSO/Pentastarch)RPMI 1640X-VIVO 20 (contains gentamycin)RPMI 1640 w/ multiple antibioticsEach sample seeded with 10 and 50 CFU of 10 different organisms CFR vs BacT/Alert vs BactecBoth BacT/Alert and Bactec were superior to CFR in overall organism detectionN=6x3x2=36; except AN, n=28CFR/USPBoth BacT/Alert and Bactec were superior to CFR in time to detectionEven for inocula of 10 CFU, time to detection was 7 days for both BacT/Alert and Bactec (but not for CFR)BacT/AlertBactecMultiple antibiotics in product medium impaired detection of organisms in all systemsN=10x3x2=60In medium with multiple antibiotics, impaired detection was variable from one organism to the nextNo GrowthSA, YE, BS, ANNo GrowthSA, ML, BS, PBParallel Study: DesignGoal: evaluate field performance, false positives (true pos evaluation is best done by seeded study)Tested in process and final product samples from real cell therapy productsTimeframes12/1/02 - 5/16/04BacT/Alert vs CFR 1125 samples5/17/04 – 12/31/05Bactec vs CFR 492 samplesDefinition of positive resultsPositive results expressed asTrue positive = detection by system + confirmation by gram stain and/or subcultureFalse positive = detection by system, but could not confirm pr