NT-proBNP on Cobas h 232 in point-of-care testing: Performance in the primary health care versus in the hospital laboratory

Abstract

Background. NT-proBNP may be useful for ruling out heart failure in primary health care. In this study we examined the analytical quality of NT-proBNP in primary health care on the Cobas h 232 point-of-care instrument compared with measurements performed in a hospital laboratory. Materials and methods. Blood samples requested for NT-proBNP were collected in primary health care (n = 95) and in a hospital laboratory (n = 107). NT-proBNP was measured on-site on Cobas h 232 instruments both in primary health care centres and at the hospital laboratory and all samples were also analyzed with a comparison method at the hospital. Precision, trueness, accuracy, and lot-variation were determined at different concentration levels and evaluated according to acceptance criteria. Furthermore user-friendliness was assessed by questionnaires. Results. For Cobas h 232 repeatability CV was 8.5–10.7% in the hospital setting and 5.3–10.0% in the primary health care and within the analytical quality specifications, but higher than with the comparison method (< 4%). NT-proBNP results obtained in primary health care were significantly higher than by the hospital comparison method (bias ranged from 14.3–23.7%), whereas there was no significant bias when Cobas h 232 was used in the hospital setting (bias ranged from − 4.9 to 7.0%). User-friendliness of Cobas h 232 was overall acceptable. Conclusion. Cobas h 232 point-of-care instrument for measurement of NT-proBNP performed satisfactorily with regard to precision, user-friendliness, and lot-variation. A decrease in NT-proBNP levels observed in samples transported to a central laboratory needs further attention and investigation.

Key Words::

• Natriuretic peptide
• biological markers
• heart disease
• point-of-care systems
• validation studies

Acknowledgements

The authors would like to thank SKUP and especially Grete Monsen for the opportunity to use the data from their evaluation of the Cobas h 232 POC system. We also would like to thank Tor-Arne Hagve, Elvar Theodorsson, Sverre Sandberg, Olav Klingenberg, Holger Jon Møller, Anders Kallner, Axel Brock and Jens Peter Berg for their support in the writing process during the ‘Course in Manuscript Writing and Publishing’ at Finse (Norway), January 2014. Finally, a special thanks to Holger Jon Møller for helping us to complete the manuscript. Roche has supported the investigation financially and has had the opportunity to read the final manuscript before submission.

This article is the result of the manuscripts written by each of four groups as a part of the ‘Course of Manuscript Writing and Publishing’ organized by the Editorial Board of the Scandinavian Journal of Clinical and Laboratory Investigation and The Nordic Society of Clinical Chemistry at Finse, Norway, January 2014. Each of the three first authors has contributed equally in merging the four manuscripts and preparing the final manuscript, while the rest of the authors have contributed equally during the course and their names are presented in alphabetical order in the list of authors.

The data are used with permission from SKUP (Scandinavian Evaluation of Laboratory Equipment for Primary Health Care), Norway.

Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the content and writing of the paper.

Supplemental data

The underlying research materials for this article can be accessed at: http://www.skup.nu/ and http://informahealthcare.com/doi/abs/10.3109/00365513.2015.1066846.