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 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® and ARCHITECT assays in plasma (slope 1.02, intercept -. 2.72. pg/mL). The Elecsys® 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® 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.
Original language | English |
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Pages (from-to) | 388-395 |
Number of pages | 8 |
Journal | Clinica Chimica Acta |
Volume | 438 |
DOIs | |
State | Published - 1 Jan 2015 |
Externally published | Yes |
Keywords
- Differential diagnosis
- Immunoassay
- ProGRP
- Progastrin-releasing peptide
- SCLC
- Stability