Novel Diagnostic Platforms for Clinical Microbiology and Sterility Testing for Cell Therapy

传统的微生物工作是缓慢的，有时是不准确的，依靠表型培养鉴定，然后进行抗菌药物敏感性试验。较新的技术，如基质辅助激光解吸电离飞行时间质谱（MALDI-TOF MS）和实时分子检测（抗微生物基因微阵列），提高了临床微生物实验室的诊断能力，并创造了一个令人兴奋的研究和发展领域。鉴于这些平台产生的深入和高度准确（有时是复杂的）结果，需要进行仔细详细的分析，以更好地了解所鉴定的生物体的临床意义和检测到的耐药机制。

Traditional microbiological work up is slow and sometimes inaccurate, relying on phenotypic culture identification followed by antimicrobial susceptibility testing. Newer technologies, such as matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) and real-time molecular detection (antimicrobial resistance genes microarrays) have advanced the diagnostic capabilities of clinical microbiology laboratories and have created an exciting field for research and development. Given the in-depth and highly accurate (sometimes complex) results that are produced by such platforms, careful detailed analyses are required to better understand the clinical significance of the organisms identified and the resistance mechanisms detected. During this fiscal year, we performed a large comparative evaluation of the compendial USP<71> method against the automated Bactec FX system and BacTAlert Dual-T system using 118 organisms recovered from cGMP environments to assess analytical performance for the detection of environmental contaminants in cell therapy products. This study is the largest of its kind to date, and provides strong data to support the clinical application of certain automated culture systems and settings, if supplemented with improved fungal detection methods, as an alternative method to the USP<71> compendial method. The limitations of clinical systems to detect environmental contaminants in products is important as the demand for cell therapy expands in the clinical setting.