Development and Evaluation of Novel Applied Diagnostic Platforms for Clinical Microbiology

临床微生物学新型应用诊断平台的开发和评估

• 批准号: 9552569
• 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/9552569
• 关键词: Antimicrobial Resistance; Antimicrobial susceptibility; Area; Biological Assay; Blood; Clinical; Clinical Microbiology; Complex; Data; Detection; Development; Diagnosis; Diagnostic; Evaluation; Goals; Guidelines; Infection; Infection Control; Laboratories; MALDI-TOF Mass Spectrometry; Mainstreaming; Manuals; Measures; Methods; Microbiology; Molecular; Monitor; Organism; Patient Care; Performance; Phenotype; Predictive Value; Predisposition; Proteomics; Reporting; Specimen; Standardization; System; Test Result; Testing; Time; Virtual System; Weight; antimicrobial; carbapenem resistance; carbapenemase; clinically significant; comparative; gastrointestinal; improved; microorganism; molecular phenotype; new technology; novel; novel diagnostics; novel therapeutics; pathogen; prospective; research and development; resistance gene; resistance mechanism; response; sterility testing; targeted treatment

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 retrospective analysis on the clinical performance of HardyCHROM CRE media for the detection of carbapenemase-producing organisms from surveillance cultures. Data showed a positive predictive value ranging 8-56% depending on the definition carbapenem resistant organisms applied which varies between states and national guidelines. This has a tremendous effect on applied infection control practices and antimicrobial choices in response to a potential clinical infection. We also performed a comparative evaluation of three phenotypic assays for the detection of carbapenemases, as well as a retrospective analysis on the performance and accuracy of MALDI-TOF MS and susceptibility testing directly from positive blood cultures. The latter has provided informative results for clinical microbiology reporting while awaiting standardized testing results. Quality improvement projects have included a prospective comparative evaluation of blood culture volume monitoring methods (weight vs virtual system), comparative analysis of a multiplex gastrointestinal pathogen panel with traditional methods, and a large comparative assessment of product sterility testing systems for novel therapies (traditional USP<71> manual method vs automated Bactec FX system and BacTAlert Dual-T system).

传统的微生物学工作缓慢，有时不准确，依靠表型培养鉴定，然后进行抗菌敏感性测试。诸如飞行质谱法（MALDI-TOF MS）和实时分子检测（抗微生物耐药基因微阵列）的较新技术，例如辅助飞行质谱仪（MALDI-TOF MS）的电离电离时间，已提高了临床微生物学实验室的诊断能力，并为研究和开发创造了令人兴奋的领域。鉴于此类平台产生的深入且高度准确（有时是复杂）的结果，需要进行仔细的详细分析，以更好地了解所鉴定的生物的临床意义和检测到的抗性机制。 在这个财政年度，我们对Hardychrom CRE培养基的临床表现进行了大量回顾性分析，以检测监视培养物中碳纤维酶产生的生物。数据显示，根据抗碳青霉烯的定义抗碳青霉烯的定义，在国家和国家准则之间有所不同，预测价值为8-56％。对于潜在的临床感染，这对应用感染控制实践和抗菌选择具有巨大影响。我们还对三种表型测定法进行了比较评估，以检测碳青霉酶，以及对MALDI-TOF MS的性能和准确性和直接从阳性血液培养物进行的敏感性测试的回顾性分析。后者为临床微生物学报告提供了丰富的结果，同时等待标准化的测试结果。 Quality improvement projects have included a prospective comparative evaluation of blood culture volume monitoring methods (weight vs virtual system), comparative analysis of a multiplex gastrointestinal pathogen panel with traditional methods, and a large comparative assessment of product sterility testing systems for novel therapies (traditional USP<71> manual method vs automated Bactec FX system and BacTAlert Dual-T system).