To 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 for Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis, Enterococcus faecalis, Escherichia coli and Pseudomonas aeruginosa; in anaerobic vials for Cutibacterium (Propionibacterium) acnes and Clostridium sporogenes; and only in aerobic vials for Candida albicans and Aspergillus 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% of cases,respectively. Uninhibited growth appeared in the tissue biopsies and homogenized tissues with and without antibiotics and in other solutions. BD BACTEC blood culture system with GentleMACS Dissociator is a rapid and efficient tool for detection of contamination in cardio-vascular tissues aimed for human application.

展示我们对 BD BACTEC FX 血液培养系统的验证研究，用于心血管组织的无菌测试，旨在用于人类应用。对于操作认证，我们对系统进行了温度测绘，使用未接种的 BACTEC 小瓶进行真空测试，并通过将污染物菌株注入需氧和厌氧瓶进行生长促进测试。对于性能鉴定，进行了阴性对照、方法适用性评估、灵敏度限制评估、同种异体移植活检样品中抗生素中和的控制和组织毒性效应。组织样本和运输/冷冻保存溶液在 GentleMACS Dissociator 中均质化，然后注入 BACTEC Plus 需氧和厌氧小瓶中，在 35°C 下孵育 14 天。组织中掺入需氧和厌氧细菌和真菌。污染物的增长出现在所有需氧和厌氧小瓶中金黄色葡萄球菌、表皮葡萄球菌、枯草芽孢杆菌、粪肠球菌、大肠杆菌和铜绿假单胞菌；在用于痤疮皮杆菌（丙酸杆菌）和产孢梭菌的厌氧小瓶中；并且仅在用于白色念珠菌和巴西曲霉的需氧瓶中. 大多数细菌菌株在两天内被检测到（59-100%），特别是在 3 到 14 天之间。相比之下，在 33.3%、71.6%、96.6% 和 99.9% 的病例中，分别在 2、3-6、7-10 天和 10 天后检测到真菌污染。未受抑制的生长出现在有和没有抗生素的组织活检和匀浆组织以及其他溶液中。带有 GentleMACS Dissociator 的 BD BACTEC 血液培养系统是一种快速有效的工具，用于检测人体应用的心血管组织中的污染。