title: Development of a novel, N-terminal-proBNP (NT-proBNP) assay with a low detection limit.
abstract: A novel, highly sensitive and specific N-Terminal-proBNP (NT-proBNP) assay based on a sandwich format has been developed. The assay time is below 2 hours and no extraction process is needed. The calibration curve covers a NT-proBNP concentration range from 0 pmol/L up to 600 pmol/L. The analytical detection limit of the assay was estimated to be 2.7 pmol/L (3 SD). The intra-assay coefficient of variation is 5.7% (at 50 pmol/L) and 6.1% (at 250 pmol/L), while the inter-assay CVs are 15.8% (15 pmol/L) and 8.2% (250 pmol/L). There is no significant interference by bilirubin (up to 900 mumol/L), haemoglobin (up to 10 g/L), rheumatoid factors (up to 975 IU/mL), triglycerides (up to 20.5 mmol/L), biotin (up to 50 micrograms/L), digoxin (up to 100 micrograms/L) and digitoxin (up to 200 micrograms/L). The analyte NT-proBNP is fully stable in whole blood over 3 days and in EDTA-plasma over 24 hours. This good stability of NT-proBNP compared to other less stable natriuretic peptides is a significant advantage and a main prerequisite for a routine diagnostic marker. Preliminary results of using this new assay in clinical studies for diagnosing and monitoring left ventricular dysfunction demonstrate that there is a significant gain in diagnostic validity.
authors.affiliation: Roche Diagnostics GmbH, Tutzing, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Karl
authors.forename: A
authors.initials: A
authors.lastname: Borgya
authors.forename: A
authors.initials: A
authors.lastname: Gallusser
authors.forename: E
authors.initials: E
authors.lastname: Huber
authors.forename: K
authors.initials: K
authors.lastname: Krueger
authors.forename: W
authors.initials: W
authors.lastname: Rollinger
authors.forename: J
authors.initials: J
authors.lastname: Schenk
mesh_terms: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D002138:Calibration; D002614:Chelating Agents; D002624:Chemistry, Clinical / Q000379:methods / Q000592:standards; D003327:Coronary Disease / Q000097:blood* / Q000175:diagnosis; D004492:Edetic Acid; D006801:Humans; D007118:Immunoassay / Q000379:methods; D020097:Natriuretic Peptide, Brain; D009419:Nerve Tissue Proteins / Q000032:analysis* / Q000097:blood* / Q000276:immunology; D010446:Peptide Fragments / Q000032:analysis* / Q000097:blood* / Q000276:immunology; D011498:Protein Precursors / Q000032:analysis* / Q000097:blood* / Q000276:immunology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D002614:Chelating Agents; D009419:Nerve Tissue Proteins; D010446:Peptide Fragments; D011498:Protein Precursors; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D004492:Edetic Acid