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

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