Fulltext

Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood

Zugck, Christian ; Nelles, Manfred ; Katus, Hugo A. ; Collinson, Paul O. ; Gaze, David C. ; Dikkeschei, Bert ; Gurr, Eberhard ; Hayen, Wiebke ; Haass, Markus ; Hechler, Christoph ; van Hoof, Viviane ; Guerti, Khadija ; van Waes, Carl ; Printzen, Gert ; Klopprogge, Kai ; Schulz, Ilse ; Zerback, Rainer

In: Clinical Chemical Laboratory Medicine, 2006, vol. 44, no. 10, p. 1269-1277

Add to personal list
    Title
    • Multicentre evaluation of a new point-of-care test for the determination of NT-proBNP in whole blood
    Author
    • Zugck, Christian. Abteilung für Kardiologie, Angiologie und Pulmonologie, Universitätsklinikum Heidelberg, Heidelberg, Germany
    • Nelles, Manfred. Abteilung für Kardiologie, Angiologie und Pulmonologie, Universitätsklinikum Heidelberg, Heidelberg, Germany
    • Katus, Hugo A.. Abteilung für Kardiologie, Angiologie und Pulmonologie, Universitätsklinikum Heidelberg, Heidelberg, Germany
    • Collinson, Paul O.. Chemical Pathology, St. George's Hospital, London, UK
    • Gaze, David C.. Chemical Pathology, St. George's Hospital, London, UK
    • Dikkeschei, Bert. Isala Klinieken, Zwolle, The Netherlands
    • Gurr, Eberhard. Abteilung für Klinische Chemie und Zentrallabor, Zentralkrankenhaus Links der Weser, Bremen, Germany
    • Hayen, Wiebke. Abteilung für Klinische Chemie und Zentrallabor, Zentralkrankenhaus Links der Weser, Bremen, Germany
    • Haass, Markus. Kardiologie, Theresienkrankenhaus Mannheim, Mannheim, Germany
    • Hechler, Christoph. Kardiologie, Theresienkrankenhaus Mannheim, Mannheim, Germany
    • van Hoof, Viviane. Centraallabor, Universitair Ziekenhuis Antwerpen, Edegem, Belgium
    • Guerti, Khadija. Centraallabor, Universitair Ziekenhuis Antwerpen, Edegem, Belgium
    • van Waes, Carl. Centraallabor, Universitair Ziekenhuis Antwerpen, Edegem, Belgium
    • Printzen, Gert. Institut für Klinische Chemie, Inselspital Bern, Bern, Switzerland
    • Klopprogge, Kai. Exco Engineering Systemtechnik und Consulting GmbH, Maxdorf, Germany
    • Schulz, Ilse. Evaluation Department Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany
    • Zerback, Rainer. Evaluation Department Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany
    Document Type
    • Postprint
    Language
    • English
    Published in
    • Clinical Chemical Laboratory Medicine, 2006, vol. 44, no. 10, p. 1269-1277. Walter de Gruyter
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:294057
    Summary
    Background: The Roche CARDIAC proBNP point-of-care (POC) test is the first test intended for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in whole blood as an aid in the diagnosis of suspected congestive heart failure, in the monitoring of patients with compensated left-ventricular dysfunction and in the risk stratification of patients with acute coronary syndromes. Methods: A multicentre evaluation was carried out to assess the analytical performance of the POC NT-proBNP test at seven different sites. Results: The majority of all coefficients of variation (CVs) obtained for within-series imprecision using native blood samples was below 10% for both 52 samples measured ten times and for 674 samples measured in duplicate. Using quality control material, the majority of CV values for day-to-day imprecision were below 14% for the low control level and below 13% for the high control level. In method comparisons for four lots of the POC NT-proBNP test with the laboratory reference method (Elecsys proBNP), the slope ranged from 0.93 to 1.10 and the intercept ranged from 1.8 to 6.9. The bias found between venous and arterial blood with the POC NT-proBNP method was ≤5%. All four lots of the POC NT-proBNP test investigated showed excellent agreement, with mean differences of between −5% and +4%. No significant interference was observed with lipaemic blood (triglyceride concentrations up to 6.3mmol/L), icteric blood (bilirubin concentrations up to 582μmol/L), haemolytic blood (haemoglobin concentrations up to 62mg/L), biotin (up to 10mg/L), rheumatoid factor (up to 42IU/mL), or with 50 out of 52 standard or cardiological drugs in therapeutic concentrations. With bisoprolol and BNP, somewhat higher bias in the low NT-proBNP concentration range (<175ng/L) was found. Haematocrit values between 28% and 58% had no influence on the test result. Interference may be caused by human anti-mouse antibodies (HAMA) types 1 and 2. No significant influence on the results with POC NT-proBNP was found using volumes of 140-165μL. High NT-proBNP concentrations above the measuring range of the POC NT-proBNP test did not lead to false low results due to a potential high-dose hook effect. Conclusions: The POC NT-proBNP test showed good analytical performance and excellent agreement with the laboratory method. The POC NT-proBNP assay is therefore suitable in the POC setting. Clin Chem Lab Med 2006;44:1269-77