Analytical performance and diagnostic accuracy of a fully-automated electrochemiluminescent assay for the N-terminal fragment of the pro-peptide of brain natriuretic peptide in patients with cardiomyopathy: comparison with immunoradiometric assay methods for brain natriuretic peptide and atrial natriuretic peptide
-
Concetta Prontera
Abstract
We evaluated the analytical performance of a fully-automated electrochemiluminescence “sandwich” immunoassay method for the N-terminal fragment of the pro-peptide of brain natriuretic peptide (BNP). We then compared the diagnostic accuracy of this method in discriminating between normal subjects and patients with cardiomyopathy with that found with two previously described immunoradiometric assay methods for the assay of atrial natriuretic peptide (ANP) and BNP. We studied 193 consecutive patients (mean age 64.4±12.3 years, range 20–89 years, including 56 women and 137 men) with chronic cardiomyopathy and a group of 85 healthy subjects (mean age 52.3±12.0 years, 42 women and 43 men, range 20–79 years). N-terminal fragment of proBNP1–76 (NT-proBNP) was measured with a fully-automated “sandwich” electrochemiluminescence method using an Elecsys® 2010 analyzer, while ANP and BNP were measured with immunoradiometric assay methods. The low detection limit of the NTproBNP assay was 4.2 pg/ml (0.50 pmol/l), while the functional sensitivity was 22 pg/ml (2.60 pmol/l) with a working range (imprecision profile ≤ 10% coefficient of variation) extended up to about 30 000 pg/ml (3540 pmol/l). Healthy women (64.3±41.6 pg/ml, 7.59±4.91 pmol/l) showed significantly higher values than men (46.9±30.9 pg/ml, 5.53±3.64 pmol/l, p=0.0118). Moreover, age and sex were significantly and independently related to the NT-proBNP values in healthy subjects, as assessed by a multiple linear regression analysis (R=0.389, F-value=7.316, P-value=0.0012). As expected, the NT-proBNP values of patients with cardiomyopathy were significantly higher than those of normal subjects and progressively increased with the severity of heart failure. The respective diagnostic accuracy of the ANP, BNP and NT-proBNP assays in discriminating between the group of normal subjects and that of patients with cardiomyopathy was tested by the response operating characteristic curve analysis. Our data indicated that the NT-proBNP assay is significantly better than either of the ANP or BNP immunoradiometric assays in discriminating affected patients from healthy subjects, especially when only patients with mild disease severity (New York Heart Association class I and II) are considered.
Copyright (c) 2004 by Walter de Gruyter GmbH & Co. KG
Articles in the same Issue
- International collaboration in clinical chemistry and laboratory medicine: the Human Proteome Organization (HUPO) Plasma Proteome Project
- Current concepts in standardization of cardiac marker immunoassays
- Collagen, ageing and nutrition
- Evaluation of a new efficient procedure for single-nucleotide polymorphism genotyping: tetra-primer amplification refractory mutation system-polymerase chain reaction
- High prevalence of non-HFE gene-associated haemochromatosis in patients from southern Italy
- Limited usefulness of the PFA-100™ for the monitoring of ADP receptor antagonists–in vitro experience
- Isolation of plasma small-dense low-density lipoprotein using a simple air-driven ultracentrifuge and quantification using immunassay of apolipoprotein B
- Analytical performance and diagnostic accuracy of a fully-automated electrochemiluminescent assay for the N-terminal fragment of the pro-peptide of brain natriuretic peptide in patients with cardiomyopathy: comparison with immunoradiometric assay methods for brain natriuretic peptide and atrial natriuretic peptide
- Calcium oxalate crystallization in untreated urine, centrifuged and filtered urine and ultrafiltered urine
- Matrix effects in clinical immunoassays and the effect of preheating and cooling analytical samples
- Blood alcohol testing: comparison of the performance obtained with the different methods used in the Belgian external quality assessment schemes
- Determination of lipase catalytic activity in two reference materials: BCR 693 and BCR 694 by titrimetry at constant pH
- Evaluation of a new generation of plastic evacuated blood-collection tubes in clinical chemistry, therapeutic drug monitoring, hormone and trace metal analysis
- Association between the CYP2C9 polymorphism and the drug metabolism phenotype
- Analytical goals for coagulation tests based on biological variation
- In vivo total antioxidant capacity: comparison of two different analytical methods
- Performance evaluation of automated assays for β-CrossLaps, N-MID-Osteocalcin and intact parathyroidhormone (BIOROSE Multicenter Study)
- Evaluation of the blood gas analyzer GEM(r) PREMIER(tm) 3000
- Lactate dehydrogenase (LD) extra isoenzyme electrophoretic band between LD1 and LD2 caused by a complex with α1-lipoprotein. A case report
- Relationship between cryoglobulins and hepatitis C virus (HCV) core antigen or antibody titers
- Spurious hyperphosphatemia due to sample contamination with heparinized saline from an indwelling catheter
- Biological variation of plasma chromogranin A
- Verification, validation and evaluation of analytical procedures in laboratory medicine
- DACH-LIGA Homocystein (German, Austrian and Swiss Homocysteine Society): Consensus Paper on the Rational Clinical Use of Homocysteine, Folic Acid and B-Vitamins in Cardiovascular and Thrombotic Diseases: Guidelines and Recommendations
- Meetings and Awards
Articles in the same Issue
- International collaboration in clinical chemistry and laboratory medicine: the Human Proteome Organization (HUPO) Plasma Proteome Project
- Current concepts in standardization of cardiac marker immunoassays
- Collagen, ageing and nutrition
- Evaluation of a new efficient procedure for single-nucleotide polymorphism genotyping: tetra-primer amplification refractory mutation system-polymerase chain reaction
- High prevalence of non-HFE gene-associated haemochromatosis in patients from southern Italy
- Limited usefulness of the PFA-100™ for the monitoring of ADP receptor antagonists–in vitro experience
- Isolation of plasma small-dense low-density lipoprotein using a simple air-driven ultracentrifuge and quantification using immunassay of apolipoprotein B
- Analytical performance and diagnostic accuracy of a fully-automated electrochemiluminescent assay for the N-terminal fragment of the pro-peptide of brain natriuretic peptide in patients with cardiomyopathy: comparison with immunoradiometric assay methods for brain natriuretic peptide and atrial natriuretic peptide
- Calcium oxalate crystallization in untreated urine, centrifuged and filtered urine and ultrafiltered urine
- Matrix effects in clinical immunoassays and the effect of preheating and cooling analytical samples
- Blood alcohol testing: comparison of the performance obtained with the different methods used in the Belgian external quality assessment schemes
- Determination of lipase catalytic activity in two reference materials: BCR 693 and BCR 694 by titrimetry at constant pH
- Evaluation of a new generation of plastic evacuated blood-collection tubes in clinical chemistry, therapeutic drug monitoring, hormone and trace metal analysis
- Association between the CYP2C9 polymorphism and the drug metabolism phenotype
- Analytical goals for coagulation tests based on biological variation
- In vivo total antioxidant capacity: comparison of two different analytical methods
- Performance evaluation of automated assays for β-CrossLaps, N-MID-Osteocalcin and intact parathyroidhormone (BIOROSE Multicenter Study)
- Evaluation of the blood gas analyzer GEM(r) PREMIER(tm) 3000
- Lactate dehydrogenase (LD) extra isoenzyme electrophoretic band between LD1 and LD2 caused by a complex with α1-lipoprotein. A case report
- Relationship between cryoglobulins and hepatitis C virus (HCV) core antigen or antibody titers
- Spurious hyperphosphatemia due to sample contamination with heparinized saline from an indwelling catheter
- Biological variation of plasma chromogranin A
- Verification, validation and evaluation of analytical procedures in laboratory medicine
- DACH-LIGA Homocystein (German, Austrian and Swiss Homocysteine Society): Consensus Paper on the Rational Clinical Use of Homocysteine, Folic Acid and B-Vitamins in Cardiovascular and Thrombotic Diseases: Guidelines and Recommendations
- Meetings and Awards
