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Multicenter evaluation of a new progastrin-releasing peptide (ProGRP) immunoassay across Europe and China

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机构: [a]The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066CX, The Netherlands [b]University Hospital Bonn and Center of Integrative Oncology Cologne/Bonn, Sigmund-Freud-Strasse, Bonn 25-53127, Germany [c]Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Xicheng District, Beijing 100053, China [d]Peking Union Medical College Hospital (PUMCH), 1Shuaifuyuan, Dongcheng District, Beijing 100730, China [e]Roche Diagnostics GmbH, Nonnenwald 2, Penzberg 82377, Germany [f]Hospital Clinic, University of Barcelona, Carrer Villarroel 170, Barcelona 08036, Spain
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关键词: Differential diagnosis Immunoassay Progastrin-releasing peptide ProGRP SCLC Stability

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Background: We performed a multicenter evaluation of the Elecsys(R) progastrin-releasing peptide (ProGRP) immunoassay in Europe and China. Methods: The assay was evaluated at three European and two Chinese sites by imprecision, stability, method comparison and differentiation potential in lung cancer. Results: Intermediate imprecision across five analyte concentrations ranged from 2.2% to 6.0% coefficient of variation. Good stability for plasma and serum samples was shown for various storage conditions. There was excellent correlation between the Elecsys(R) and ARCHITECT assays in plasma (slope 1.02, intercept -2.72 pg/mL). The Elecsys(R) assay also showed good correlation between serum and plasma samples (slope 0.93, intercept 2.35 pg/mL; correlation coefficient 0.97). ProGRP differentiated small-cell and non-small-cell lung cancer (NSCLC; area under the curve 0.90, 95% CI 0.87-0.93; 78.3% sensitivity, 95% specificity; at 84 pg/mL), with no relevant effects of ethnicity, age, gender or smoking. Median ProGRP concentrations were low in benign diseases (38 pg/mL), other malignancies (40 pg/mL) or NSCLC (39 pg/mL), except chronic kidney disease above stage 3 (>100 pg/mL). Conclusions: Increased stability of the Elecsys(R) ProGRP assay in serum and plasma offers clear benefits over existing assays. This first evaluation of a ProGRP assay in China demonstrated comparable differentiation potential among different ethnicities. (C) 2014 The Authors. Published by Elsevier B.V.

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出版当年[2014]版:
大类 | 3 区 医学
小类 | 2 区 医学实验技术
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学实验技术
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出版当年[2013]版:
Q1 MEDICAL LABORATORY TECHNOLOGY
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Q2 MEDICAL LABORATORY TECHNOLOGY

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第一作者机构: [a]The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066CX, The Netherlands [*1]The Netherlands Cancer Institute, PO Box 90203, Plesmanlaan 121, Amsterdam 1066CX, The Netherlands.
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通讯机构: [*1]The Netherlands Cancer Institute, PO Box 90203, Plesmanlaan 121, Amsterdam 1066CX, The Netherlands.
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