College of Medical Laboratory, Dalian Medical University, Dalian, China.
J Clin Lab Anal. 2021 Dec;35(12):e24087. doi: 10.1002/jcla.24087. Epub 2021 Nov 1.
The measurement method for experimental resolution and related data to evaluate analytical performance is poorly explored in clinical research. We established a method to measure the experimental resolution of clinical tests, including biochemical tests, automatic hematology analyzer methods, immunoassays, chemical experiments, and qPCR, to evaluate their analytical performance.
Serially diluted samples in equal proportions were measured, and correlation analysis was performed between the relative concentration and the measured value. Results were accepted for p ≤ 0.01 of the correlation coefficient. The minimum concentration gradient (eg, 10%) was defined as the experimental resolution. For this method, the smaller the value, the higher the experimental resolution and the better the analytical performance.
The experimental resolution of the most common biochemical indices reached 10%, with some even reaching 1%. The results of most counting experiments showed experimental resolution up to 10%, whereas the experimental resolution of the classical chemical assays reached 1%. Unexpectedly, the experimental resolution of more sensitive assays, such as immunoassays was only 25% when using the manual method and 10% for qPCR.
This study established a method for measuring the experimental resolution of laboratory assays and provides a new index for evaluating the reliability of methods in clinical laboratories.
在临床研究中，实验分辨率的测量方法及其相关数据分析方法尚未得到充分探索。我们建立了一种方法来测量临床检验的实验分辨率，包括生化检验、自动血液分析仪方法、免疫测定、化学实验和 qPCR，以评估它们的分析性能。
以相等的比例连续稀释样本，并对相对浓度与测量值之间进行相关性分析。只有当相关系数的 p 值小于等于 0.01 时，结果才被接受。最小浓度梯度（例如 10%）被定义为实验分辨率。对于该方法，值越小，实验分辨率越高，分析性能越好。
最常见的生化指标的实验分辨率达到 10%，有些甚至达到 1%。大多数计数实验的结果显示实验分辨率高达 10%，而经典化学测定的实验分辨率达到 1%。出乎意料的是，免疫测定等更敏感测定的实验分辨率在使用手动方法时仅为 25%，而 qPCR 时为 10%。
本研究建立了一种测量实验室检测实验分辨率的方法，为评估临床实验室方法的可靠性提供了一个新指标。
