Comprehensive Evaluation of Compendial USP, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants
Comprehensive Evaluation of Compendial USP, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants
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DOI：
10.1128/jcm.01548-18
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发表时间：
2019-02-01
影响因子：
9.4
通讯作者：
Lau, Anna F.
中科院分区：
文献类型：
--
作者：
England, Matthew R.;Stock, Frida;Lau, Anna F.
细胞治疗项目在大型学术中心的出现，导致对临床实验室的需求不断增加，以协助产品无菌测试。自动血液培养系统已显示出替代手动USP药典方法的希望，但目前公布的数据受限于小型生物测试集，特别是霉菌。2015年，由于Bactec FX系统未能检测到两种产品中的霉菌污染，促使我们在七种不同的培养组合中评估了三种测试系统（药典USP、Bactec FX和BacT/Alert Dual-T），使用了118种代表NIH现行良好生产规范（cGMP）环境的挑战生物。在
The emergence of cell therapy programs in large academic centers has led to an increasing demand for clinical laboratories to assist with product sterility testing. Automated blood culture systems have shown promise as alternatives to the manual USP compendial method, but current published data are limited by small organism test sets, particularly for molds. In 2015, failure of the Bactec FX system to detect mold contamination in two products prompted us to evaluate three test systems (compendial USP, Bactec FX, and BacT/Alert Dual-T) over seven different culture combinations, using 118 challenge organisms representative of the NIH current good manufacturing practice (cGMP) environment. At