定性检测性能评估方法研究

The Study of an Evaluation Method for the Performance of Qualitative Tests

目的:建立一种评估定性检测性能的科学方法。方法:采用比较分析的方法,当诊断明确时,分别将检测方法和可比较方法与明确诊断的检测性能进行比较;当诊断不明确时,比较检测方法和可比较方法的一致程度。结果:以实例的方式将检测方法、可比较方法进行了比较,得出了性能较好的定性检测方法。结论:定性检测是临床实验室一种很重要的检测方法,其检测性能如何直接决定患者的检测结果,该评估方法的提出为临床实验室引入一种新的检测方法提供了指南。

Objective： To develop a method to evaluate the performance of qualitative tests when the laboratory dose know the clinical diagnosis. Methods： Using a comparative method to analyze the difference between the new test method and the old one and the clinical diagnosis separately when the diagnosis is known; reporting how often the test method and comparative method can agree when the true diagnosis is unknown. Results： Taking a clinical example to demonstrate a more effective performance assessment method of qualitative tests by comparing performances and reporting the percent agreement. Conclusions： Qualitative tests have been used since the early days of laboratory medicine for the screening, diagnosis and management of a variety of diseases. However, before every new qualitative test is used to clinical status, the performance of the new qualitative test must be evaluated. This method of evaluation provides a guideline for laboratory medicine using a new qualitative test.