The BD BACTEC FX blood culture system with the gentlemacs dissociator is suitable for sterility testing of heart valve and vascular allografts —A validation study

AbstractTo present our validation study of the BD BACTEC FX blood culture system for sterility testing of cardiovascular tissues aimed for human application. For operational qualification, we performed temperature mapping of the system, vacuum test using non-inoculated BACTEC vials, and growth promotion tests by injecting contaminant strains into aerobic and anaerobic bottles. For performance qualification, negative control, assessment of method suitability, evaluation of sensitivity limits, control of neutralization of antibiotics in biopsy samples from allografts and tissue toxicity effects, were performed. Tissue samples and transport/cryopreservation solutions were homogenized in GentleMACS Dissociator and injected into BACTEC Plus aerobic and anaerobic vials for incubation at 35  °C for 14 days. Tissues were spiked with aerobic and anaerobic bacteria and fungi. Growth of contaminants appeared in all aerobic and anaerobic vials forStaphylococcus aureus,Staphylococcus epidermidis,Bacillus subtilis,Enterococcus faecalis,Escherichia coli andPseudomonas aeruginosa; in anaerobic vials for Cutibacterium (Propionibacterium) acnes andClostridium sporogenes; and only in aerobic vials forCandida albicans andAspergillus brasiliensis. The majority of bacterial strains were detected within two days (59 –100%), exceptionally between 3 and 14 days. In contrast, fungal contaminations were detected within 2, 3–6, 7–10 and after 10 days of incubation in 33.3, 71.6, 96.6 and 99.9...
Source: Cell and Tissue Banking - Category: Stem Cells Source Type: research