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

Autor: Birgit Wehnl, Xiaotong Zhang, Ling Qiu, Rafael Molina, Stefan Holdenrieder, Jose M. Escudero, Mu Hu, Daan van den Broek, Andrea Geistanger, Xiuyi Zhi, Marcus-Rene Lisy, Jens Standop, Catharina M. Korse
Rok vydání: 2015
Předmět:
Male
Clinical Biochemistry
Progastrin-releasing peptide
Peptide
Biochemistry
Gastroenterology
Lung neoplasms
Carcinoma
Non-Small-Cell Lung
Carcinoma
Small Cell
Immunoassay
chemistry.chemical_classification
medicine.diagnostic_test
Plasma samples
Area under the curve
SCLC
General Medicine
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Recombinant Proteins
Europe
Area Under Curve
ProGRP
Female
Differential diagnosis
Stability
Adult
China
Analyte
medicine.medical_specialty
Coefficient of variation
Sensitivity and Specificity
lcsh:RC254-282
White People
Diagnosis
Differential
Asian People
Internal medicine
Biomarkers
Tumor
medicine
Humans
Lung cancer
Aged
Biochemistry
medical
business.industry
Biochemistry (medical)
medicine.disease
Serum samples
Peptide Fragments
Endocrinology
chemistry
business
Zdroj: Chinese Journal of Lung Cancer, Vol 20, Iss 8, Pp 568-577 (2017)
ISSN: 0009-8981
DOI: 10.1016/j.cca.2014.09.015
Popis: 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.
Databáze: OpenAIRE
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