Multicentre Evaluation of a Second Generation Point-of-Care Assay with an Extended Range for the Determination of N-Terminal Pro-Brain Natriuretic Peptide

Jorgensen, B.; Bertsch, T.; Hans-Joachim Bröker; Sch, M.äfer; Jean-Chapelle, P.; Gadisseur, R.; Cowie, M.R.; Dikkeschei, B.; Gurr, E.; Hayen, W.; Hafner, G.; Stiegler, Y.; Hans-Robert Schönherr; Strasser, R.H.; Weidtmann, B.; Folkerts, H.; Zugck, C.; Hofmann, K.; Zerback, R.

Clinical Laboratory 58(5-6): 515-525

2012


ISSN/ISBN: 1433-6510
PMID: 22783583
Document Number: 13634
Background: In the second generation of the point-of-care (POC) assay Roche CARDIAC proBNP, the upper limit of the measuring range was extended from 3000 to 9000 ng/L. Methods: A thirteen-site multicentre evaluation was carried out to assess the analytical performance of the POC NT-proBNP assay and to compare it with a laboratory N-terminal pro-brain natriuretic peptide (NT-proBNP) assay. Results: In method comparisons of six lots of POC NT-proBNP with the lab reference method (Elecsys proBNP) mean bias ranged from -10 to +17%. In lot-to-lot comparisons all six investigated lots of POC NT-proBNP showed excellent agreement, with mean bias between -7% and +2%. The majority of all coefficients of variation obtained from ten-fold measurements using 56 native blood samples were below 8%. No interference was observed with hemolytic blood (hemoglobin concentrations up to 0.12 mmol/L), lipemic blood (triglyceride concentrations up to 14.0 mmol/L) nor icteric blood (bilirubin concentrations up to 63 µmol/L). Hematocrit values between 24% and 51% had no influence on the assay result. High NT-proBNP concentrations above the measuring range of POC NT-proBNP did not lead to false low results due to potential high-dose hook effect. Results with POC NT-proBNP were not influenced by different ambient temperatures (18°C to 32°C), the sample material used, nor by over- or underdosing by 15 µL compared to the regular sample volume of 150 µL. Conclusions: The POC NT-proBNP assay showed an excellent analytical performance including a good agreement with the laboratory method. The assay is therefore suitable for its intended use in point-of-care settings.

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Multicentre Evaluation of a Second Generation Point-of-Care Assay with an Extended Range for the Determination of N-Terminal Pro-Brain Natriuretic Peptide