O'Kane D J, Ebert T A, Hallaway B J, Roberts S G, Bhuiyan A K, Tenner K S
Department of Laboratory Medicine, Mayo Foundation for Medical Education and Research, Rochester, MN 55905, USA.
Clin Chem. 1997 Sep;43(9):1771-80.
New assay development should be directed toward answering fundamental clinical questions. Caveats that must be considered before initiating assay development projects are: New assays should allow the clinician to interact with and treat a patient more effectively, thereby improving medical outcome; and new assays should facilitate recapture of system resources, enabling cost savings or reinvestment of resources. Defining the clinical questions and consideration of the caveats permit a means of prioritizing assay development activities. Laboratorians are faced with evaluating several types of development activities that lead to assay implementation in routine clinical testing. Assays can be prioritized for up-grading to newer cost-effective technologies, provided the changes maintain or improve analytical and clinical performance. Predicting which research assay will have future value is difficult when clinical performance is not fully validated. However, such assay development has the greatest potential for changing the delivery of healthcare by a clinician.
新检测方法的开发应致力于回答基本的临床问题。在启动检测方法开发项目之前必须考虑的注意事项是：新检测方法应使临床医生能够更有效地与患者互动并进行治疗，从而改善医疗结果；并且新检测方法应有助于重新获取系统资源，实现成本节约或资源再投资。明确临床问题并考虑这些注意事项可为检测方法开发活动确定优先顺序提供一种方法。实验室工作人员面临着评估多种类型的开发活动，这些活动会导致检测方法在常规临床检测中得以应用。如果检测方法的改变能保持或提高分析和临床性能，那么就可以优先将其升级为更新的具有成本效益的技术。当临床性能未得到充分验证时，很难预测哪种研究性检测方法将具有未来价值。然而，这种检测方法的开发在改变临床医生提供医疗服务方式方面具有最大潜力。
