Jenkins S G
Department of Pathology, University Medical Center, Jacksonville, FL 32209, USA.
Diagn Microbiol Infect Dis. 1995 Sep-Oct;23(1-2):53-60. doi: 10.1016/0732-8893(95)00154-9.
Technology capable of significantly influencing the practice of clinical microbiology is evolving at an ever-accelerating rate. During their early developmental years, it is difficult to predict which evolving technologies will prove amenable for use in hospital laboratory settings. With the considerable and increasing cost constraints placed on our medical institutions and the resulting budgetary pressures exerted on clinical laboratories, evaluation of developing technology is essential. The Clinical Laboratory Improvement Act of 1988 mandates correlation studies by clinical laboratories as part of the evaluation of all new assays to compare their sensitivities and specificities with those obtained using established methodologies. With shrinking numbers of technologists available for such evaluations, however, the mechanism with which this will be accomplished promises to pose a significant challenge. Factors that demand consideration in any such evaluation include (but are not restricted to) utility, accuracy, prospective time savings, cost of related instrumentation and reagents, and potential for diverse applications. Specific current examples that exemplify the need for such evaluations include the emergence of gene-based techniques such as the polymerase chain reaction as clinical tools, availability of new blood culture systems based on divergent sensor systems, and varying techniques for the the detection of antibodies and antigens for the serodiagnosis of infectious diseases. We as clinical microbiologists have the opportunity to approach the challenges confronting us regarding evaluation of developing technologies with responsible innovation and insight. Only by embracing these responsibilities can we hope to influence the impact of health care reform in the hospital laboratory setting.
能够显著影响临床微生物学实践的技术正在以前所未有的速度发展。在其早期发展阶段，很难预测哪些不断发展的技术将被证明适用于医院实验室环境。鉴于我们的医疗机构面临着巨大且不断增加的成本限制，以及由此给临床实验室带来的预算压力，对新兴技术进行评估至关重要。1988年的《临床实验室改进法案》要求临床实验室进行相关性研究，作为评估所有新检测方法的一部分，以便将其敏感性和特异性与使用既定方法获得的结果进行比较。然而，随着可用于此类评估的技术人员数量不断减少，实现这一目标的机制将面临重大挑战。在任何此类评估中都需要考虑的因素包括（但不限于）实用性、准确性、预期节省的时间、相关仪器和试剂的成本以及多种应用的潜力。当前体现此类评估必要性的具体例子包括基于基因的技术（如聚合酶链反应）作为临床工具的出现、基于不同传感系统的新型血培养系统的可用性，以及用于传染病血清学诊断的抗体和抗原检测的不同技术。作为临床微生物学家，我们有机会以负责任的创新和洞察力应对在评估新兴技术方面面临的挑战。只有承担起这些责任，我们才有希望在医院实验室环境中影响医疗保健改革的效果。
