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Development and Calibration of a New Point-of-Care Test for the Determination of NT-proBNP in Whole Blood by Thomas Bertsch, Bert Dikkeschei, Eberhard Gurr, Wiebke Hayen, Bo Jørgensen, Johannes Lotz, Margit Müller-Bardorff, Jordi Ordóñez-Llanos, Ilse Schulz, Jürgen Spinke, Marcel Thiele, Rainer Zerback

A new point-of-care test for the determination of NT-proBNP in whole blood was developed based on the existing gold-label rapid immunoassay technology of the Roche Cardiac reader system. The novel gold-labelled monoclonal antibody recognizes NT-proBNP at amino acid sequence 27 to 31, the biotinylated polyclonal antibody recog- nizes sequence 39 to 50. In a model assay based upon the reference method Elecsys proBNP and with an R & D lot of the point-of-care test, this newly selected and developed combination of antibodies showed a very good correlation with the standard Elecsys proBNP assay with correlations of 0.96 or 0.94, respectively. The test was calibra- ted according to the existing masterlot concept of the Roche CARDIAC tests with Elecsys proBNP as a reference. In a preliminary method comparison with Elecsys proBNP the accuracy of the calibration was confirmed; the bias was between 1 and 6%. Possible reasons of approximately 1 % outliers (> ± 100%) were discussed.

DOI: Clin. Lab. 2007;53:423-431