Research and Development Division, FUJIREBIO Inc., Tokyo, Japan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
J Clin Lab Anal. 2024 Oct;38(19-20):e25102. doi: 10.1002/jcla.25102. Epub 2024 Sep 16.
We developed a fully automated quantitative immunoassay for the detection of prostaglandin E-major urinary metabolite (PGE-MUM). In this study, we evaluated the analytical performance of this assay.
Sensitivity, within-run reproducibility, correlation with radioimmunoassay (RIA), cross-reactivity, dilution linearity, spike recovery performance, analyte stability, and effects of coexisting substances were evaluated. The assay was also used to measure PGE-MUM in 211 healthy people.
The limit of detection and quantification were 1.0 and 1.3 ng/mL, respectively. When the assay was performed six times in a single run, the coefficient of variation ranged from 1.4% to 2.2%. The coefficient of correlation with a preceding RIA method was 0.970 with a correlation slope of 0.88. There was no cross-reactivity with PGE-MUM analogs. Linearity of dilution was confirmed at up to 16-fold dilution with assay results within 100 ± 20% of the theoretical values calculated based on the undiluted sample. Spike recovery was good and ranged from 94% to 101%. Analyte stability was tested by storing samples at 25°C for 6 days, 10°C for 1 month, and by performing up to five freeze-thaw cycles. Assay results were all within 100 ± 10%, the values measured before storage and before the freeze-thaw process. Assay results in healthy people ranged from 3.1 to 162.7 ng/mL (mean: 35.8 ng/mL). After correction for creatinine, the 95% confidence interval was 8.68-42.25 μg/g creatinine.
The assay precisely detects PGE-MUM.
我们开发了一种用于检测前列腺素 E 主要尿代谢物 (PGE-MUM) 的全自动定量免疫分析方法。在本研究中，我们评估了该分析方法的分析性能。
评估了灵敏度、批内重复性、与放射免疫分析 (RIA) 的相关性、交叉反应性、稀释线性、加标回收率、分析物稳定性以及共存物质的影响。该方法还用于测量 211 名健康人的 PGE-MUM。
检测限和定量限分别为 1.0 和 1.3ng/mL。当在单个运行中进行六次测定时，变异系数范围为 1.4%至 2.2%。与之前的 RIA 方法的相关系数为 0.970，相关斜率为 0.88。与 PGE-MUM 类似物无交叉反应性。稀释线性度在高达 16 倍稀释时得到确认，基于未稀释样品计算的理论值，测定结果在 100±20%范围内。加标回收率良好，范围为 94%至 101%。通过在 25°C 下储存样品 6 天、在 10°C 下储存 1 个月以及进行多达 5 次冻融循环来测试分析物稳定性。所有测定结果均在 100±10%范围内，即在储存前和冻融过程前测量的值。健康人测定结果范围为 3.1 至 162.7ng/mL（平均值：35.8ng/mL）。经肌酐校正后，95%置信区间为 8.68-42.25μg/g 肌酐。
该方法可精确检测 PGE-MUM。
