Theriault A, Agdinaoay T, Ladao N B, Chang H, Grandinetti A
Division of Medical Technology, University of Hawaii at Manoa, 1960 East- West Road, Bio C-206, Honolulu, Hawaii 96822, USA.
Clin Lab Sci. 2001 Winter;14(1):6-8.
Evaluate the new Active human leptin ELISA available through Diagnostic Systems Laboratories Inc for use in clinical research laboratories.
Fasting plasma samples for this study were obtained randomly from human subjects. Precision, linearity, recovery, and interference studies were performed, in addition to method comparison with the conventional leptin RIA method and comparison between laboratories.
University of Hawaii at Manoa, Division of Medical Technology and the Native Hawaiian Health Research-RCMI laboratory.
Native Hawaiians were selected for this study since this population has consistently demonstrated a higher incidence rate of obesity and Type 2 diabetes and thus, potentially have high leptin levels.
At leptin concentrations of 2.3, 16.6, and 45.6 ng/ mL, within-run imprecision (n = 5) ranged from 3.1%, 1.6%, and 4.2%, and the between-run imprecision (n = 10) ranged from 6.8%, 4.1%, and 2.7%. The comparison-of-method gave a linear regression equation of y = 0.92x + 1.6 mg/dL (r = 0.96, n = 74, S(y/x) 2.0) when compared to the Linco human leptin RIA method. The dilution curve showed acceptable linearity within the reportable range of the assay, and the recovery was 88.5% to 112%. No interference was detected with hemoglobin up to 1 g/dL, and with triglyceride, up to 1.8 g/dL. However, bilirubin, 10 mg/dL, did show significant interference.
Overall, we feel that the new Active Human Leptin assay offers a safe and rapid alternative method appropriate for clinical research laboratories and epidemiological studies.
评估诊断系统实验室公司提供的新型活性人瘦素酶联免疫吸附测定法（ELISA）在临床研究实验室中的应用。
本研究的空腹血浆样本是从人类受试者中随机获取的。除了与传统的瘦素放射免疫分析（RIA）方法进行方法比较以及实验室间比较外，还进行了精密度、线性、回收率和干扰研究。
夏威夷大学马诺阿分校医学技术系以及夏威夷原住民健康研究 - RCMI实验室。
选择夏威夷原住民进行本研究，因为该人群一直表现出较高的肥胖症和2型糖尿病发病率，因此可能具有较高的瘦素水平。
在瘦素浓度为2.3、16.6和45.6 ng/mL时，批内不精密度（n = 5）范围为3.1%、1.6%和4.2%，批间不精密度（n = 10）范围为6.8%、4.1%和2.7%。与Linco人瘦素RIA方法相比，方法比较得出线性回归方程为y = 0.92x + 1.6 mg/dL（r = 0.96，n = 74，S(y/x) 2.0）。稀释曲线在该检测方法的可报告范围内显示出可接受的线性，回收率为88.5%至112%。血红蛋白浓度高达1 g/dL以及甘油三酯浓度高达1.8 g/dL时均未检测到干扰。然而，胆红素浓度为10 mg/dL时确实显示出显著干扰。
总体而言，我们认为新型活性人瘦素检测法为临床研究实验室和流行病学研究提供了一种安全、快速的替代方法。
