Analytical and clinical evaluation of a novel high-sensitivity assay for measurement of soluble ST2 in human plasma - The Presage™ ST2 assay

被引：200

作者：

Dieplinger, Benjamin ^{[1
]}

Januzzi, James L., Jr. ^{[2
,3
]}

Steinmair, Martin ^{[1
]}

Gabriel, Christian ^{[4
]}

Poelz, Werner ^{[5
]}

Haltmayer, Meinhard ^{[1
]}

Mueller, Thomas ^{[1
]}

机构：

[1] Konventhosp Barmherzige Brueder, Dept Lab Med, A-4020 Linz, Austria

[2] Massachusetts Gen Hosp, Div Cardiol, Boston, MA 02114 USA

[3] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA

[4] Red Cross Transfus Serv Upper Austria, Linz, Austria

[5] Univ Linz, Inst Appl Syst Sci & Stat, A-4040 Linz, Austria

来源：

CLINICA CHIMICA ACTA | 2009年 / 409卷 / 1-2期

关键词：

Heart failure; Inflammation; Interleukin-1 receptor family; Natriuretic peptides; Pneumonia; Sepsis; RESPIRATORY-DISTRESS-SYNDROME; FAMILY-MEMBER ST2; HEART-FAILURE; MYOCARDIAL-INFARCTION; BIOLOGICAL VARIATION; NATRIURETIC PEPTIDE; 1-YEAR MORTALITY; BIOMARKER; RECEPTOR; PROTEIN;

D O I：

10.1016/j.cca.2009.08.010

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Background: The protein ST-2 is a member of the interleukin-1 receptor family. Blood concentrations of the soluble isoform of M (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 (TM) ST2 assay for the determination of sST2 in human plasma. Methods: 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. Results: 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. Conclusion: The Presage (TM) 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. (C) 2009 Elsevier B.V. All rights reserved.

引用

页码：33 / 40

页数：8

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