Department of Pathology, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-0428, USA.
Arch Pathol Lab Med. 2011 Jan;135(1):83-91. doi: 10.5858/2010-0260-RAR.1.
Molecular diagnostics continues to evolve very rapidly, and its impact in the diagnosis of infectious diseases is undeniable. Molecular tools have played a pivotal role in discovering and characterizing several emerging infectious agents and have now become the gold standard for the diagnosis of infectious diseases caused by fastidious or uncultivable agents. Multiple challenges still remain for the widespread use of cost-effective, validated, and commercially available molecular tools. Automated instruments capable of sample processing and multiplex nucleic acid amplification and postamplification analysis have already been approved by the US Food and Drug Administration (FDA) for use in the clinical setting. Nanobiotechnology is beginning to impact laboratory diagnostics in the clinical setting.
To address current nucleic acid techniques used in the clinical laboratory for diagnosis of infectious diseases. FDA-approved tests are listed, as well as molecular techniques (amplification and postamplification analysis). A comprehensive list of emerging pathogens during the last 4 decades is also presented. Biosurveillance systems are discussed in the context of molecular tools. The rapidly evolving field of nanobiotechnology is briefly addressed.
Original publications, major reviews, and book chapters were used to present a comprehensive, yet short, review of molecular diagnostics in infectious diseases.
We will continue to witness an exponential growth of molecular techniques used for the initial diagnosis of infectious diseases. Molecular tools will also continue to have an impact on disease prognosis and response to therapeutic interventions. Automation, multiplexing, and miniaturization will continue to be driving forces in the development of new instruments.
分子诊断学发展迅速,其在传染病诊断中的作用不可否认。分子工具在发现和鉴定多种新发传染病病原体方面发挥了关键作用,现已成为诊断苛养或难以培养病原体所致传染病的金标准。广泛应用经济有效、经验证且可商业化的分子工具仍面临诸多挑战。能够进行样本处理和多重核酸扩增及扩增后分析的自动化仪器已获美国食品和药物管理局(FDA)批准用于临床。纳米生物技术开始对临床实验室的诊断产生影响。
介绍目前临床实验室用于诊断传染病的核酸技术。列出了 FDA 批准的检测方法和分子技术(扩增和扩增后分析)。还列出了过去 40 年中出现的新病原体。讨论了生物监测系统在分子工具方面的应用。简要介绍了快速发展的纳米生物技术领域。
原始出版物、主要综述和书籍章节被用于对传染病的分子诊断进行全面但简短的综述。
我们将继续见证用于传染病初始诊断的分子技术呈指数级增长。分子工具也将继续对疾病预后和治疗干预反应产生影响。自动化、多重化和小型化将继续成为新仪器开发的推动因素。