Todd John, Freese Bob, Lu Ann, Held Douglas, Morey Jennifer, Livingston Richard, Goix Philippe
Singulex, Inc., Hayward, CA 94545, USA.
Clin Chem. 2007 Nov;53(11):1990-5. doi: 10.1373/clinchem.2007.091181. Epub 2007 Sep 21.
Immunoassay (IA) technology has expanded the clinical utility of protein biomarkers, but demands for increased sensitivity, dynamic reporting ranges, and small sample volumes have limited the potential clinical usefulness of many biomarkers. We assessed the performance, including limits of detection (LODs) and the dynamic reporting range, of an IA-based technology, Erenna Immunoassay System, for a series of biomarkers, including cardiac troponin I (cTnI).
Erenna IAs were used with 10 different and clinically important biomarkers to ascertain the LOD with various sample sizes (10 microL to 200 microL).
The Erenna Immunoassay System generated LODs of 10-100 pg/L using 100 microL of sample. For cTnI, the LOD was 0.2 ng/L and a 10% CV was seen between 0.78 and 1.6 ng/L.
The Erenna IA-based technology reproducibly measures protein biomarkers with detection limits of 10-100 pg/L, with a dynamic range of >4.5 logs in sample volumes of 50-150 microL.
免疫测定（IA）技术扩展了蛋白质生物标志物的临床应用，但对提高灵敏度、动态报告范围和小样本量的需求限制了许多生物标志物的潜在临床实用性。我们评估了一种基于IA的技术——Erenna免疫测定系统对一系列生物标志物（包括心肌肌钙蛋白I（cTnI））的性能，包括检测限（LOD）和动态报告范围。
使用Erenna免疫测定法检测10种不同且具有临床重要性的生物标志物，以确定不同样本量（10微升至200微升）下的检测限。
使用100微升样本时，Erenna免疫测定系统的检测限为10 - 100 pg/L。对于cTnI，检测限为0.2 ng/L，在0.78至1.6 ng/L之间观察到10%的变异系数（CV）。
基于Erenna免疫测定的技术可重复性地测量蛋白质生物标志物，检测限为10 - 100 pg/L，在50 - 150微升样本量中的动态范围大于4.5个对数。
