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

用于细胞治疗的临床微生物学和无菌测试的新型诊断平台

• 批准号: 10019273
• 负责人: Anna Lau
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10019273
• 关键词: Antimicrobial Resistance; Antimicrobial susceptibility; Area; Biological Assay; Cell Therapy; Clinical; Clinical Microbiology; Complex; Cyclic GMP; Data; Dental Laboratories; Detection; Development; Diagnosis; Diagnostic; Dialysis procedure; Ensure; Environment; Environmental Monitoring; Environmental Pollution; Evaluation; Goals; Infection Control; Infusion procedures; Laboratories; MALDI-TOF Mass Spectrometry; Mainstreaming; Measures; Methods; Microbiology; Molecular; Mycoplasma; Organism; Patient Care; Patients; Performance; Pharmacy facility; Phenotype; Process; Proteomics; Regulation; Safety; Specimen; System; Testing; Time; clinical application; clinically significant; comparative; improved; microorganism; molecular phenotype; new technology; novel; novel diagnostics; research and development; resistance gene; resistance mechanism; sterility testing; targeted treatment; water testing

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.

传统的微生物检测速度很慢，有时甚至不准确，依赖于表型培养鉴定和药敏试验。较新的技术，如基质辅助激光解吸电离飞行时间质谱仪(MALDI-TOF MS)和实时分子检测(抗菌素耐药基因芯片)，提高了临床微生物学实验室的诊断能力，创造了一个令人兴奋的研发领域。考虑到这种平台产生的深入和高度准确(有时是复杂的)结果，需要仔细详细的分析，以更好地理解所确定的微生物的临床意义和检测到的耐药机制。 在本财年，我们使用了118种从cGMP环境中回收的微生物，对简明的USP&lt；71&gt；方法与自动化的Bactec FX系统和BacTAlert双T系统进行了大规模的比较评估，以评估在细胞治疗产品中检测环境污染物的分析性能。这项研究是迄今为止同类研究中规模最大的，并提供了强有力的数据支持某些自动培养系统和环境的临床应用，如果辅之以改进的真菌检测方法，作为USP&lt；71&gt；药典方法的替代方法。随着临床环境中对细胞治疗需求的扩大，临床系统检测产品中环境污染物的局限性变得重要。