Dieplinger Benjamin, Januzzi James L, Steinmair Martin, Gabriel Christian, Poelz Werner, Haltmayer Meinhard, Mueller Thomas
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria.
Clin Chim Acta. 2009 Nov;409(1-2):33-40. doi: 10.1016/j.cca.2009.08.010. Epub 2009 Aug 20.
The protein ST2 is a member of the interleukin-1 receptor family. Blood concentrations of the soluble isoform of ST2 (sST2) are increased in inflammatory diseases and in heart disease and are considered a prognostic marker in both. The aim of this study was the analytical and clinical evaluation of the novel Presage ST2 assay for the determination of sST2 in human plasma.
We evaluated precision and linearity of the assay, analyte stability, and biological variability, determined reference values, performed a method comparison with an established ELISA, and quantified sST2 concentrations in various diseases.
Within-run and total coefficients of variation were <2.5% and <4.0%. The method was linear across the whole measurement range of the assay. The analyte was stable for 48 h at room temperature, for 7 days at 4 degrees C, and for at least 2 months at -20 degrees C and -80 degrees C. The reference change value for healthy individuals was 30%. Age-independent reference values were 3-28 U/mL in males, and 2-16 U/mL in females. The method comparison revealed a high proportional bias. sST2 plasma concentrations were increased modestly in heart failure and moderately in pneumonia and chronic obstructive pulmonary disease. Patients with sepsis exhibited highly elevated sST2 values. In patients with chronic renal disease, however, there was no difference compared to healthy individuals.
The Presage ST2 assay meets the needs of quality specifications of laboratory medicine. The results of the clinical assay evaluation are novel with respect to sST2 in various diseases and should initiate further studies.
蛋白质ST2是白细胞介素-1受体家族的成员。可溶性ST2（sST2）的血药浓度在炎症性疾病和心脏病中均升高，被认为是这两种疾病的预后标志物。本研究的目的是对用于测定人血浆中sST2的新型Presage ST2检测方法进行分析和临床评估。
我们评估了该检测方法的精密度和线性、分析物稳定性以及生物学变异性，确定了参考值，与已建立的酶联免疫吸附测定法进行了方法比较，并对各种疾病中的sST2浓度进行了定量。
批内和总变异系数分别<2.5%和<4.0%。该方法在整个检测范围内呈线性。分析物在室温下稳定48小时，在4℃下稳定7天，在-20℃和-80℃下稳定至少2个月。健康个体的参考变化值为30%。年龄无关的参考值男性为3 - 28 U/mL，女性为2 - 16 U/mL。方法比较显示出较高的比例偏差。心力衰竭患者的sST2血浆浓度略有升高，肺炎和慢性阻塞性肺疾病患者的sST2血浆浓度中度升高。脓毒症患者的sST2值显著升高。然而，慢性肾病患者与健康个体相比无差异。
Presage ST2检测方法满足检验医学质量规范的要求。临床检测评估结果在各种疾病中sST2方面具有新颖性，应启动进一步研究。
