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

Gils, Charlotte; Ramanathan, Ramshanker; Breindahl, Torben; Brokner, Mette; Christiansen, Anne L.; Eng, Oyvin; Hammer, Ida J.; Herrera, Catherine B.; Jansen, Aina and Langsjoen, Eva C., et al. (2015) In Scandinavian Journal of Clinical & Laboratory Investigation 75(7). p.602-609
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... (More)
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. (Less)
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published
subject
keywords
Natriuretic peptide, biological markers, heart disease, point-of-care, systems, validation studies
in
Scandinavian Journal of Clinical & Laboratory Investigation
volume
75
issue
7
pages
602 - 609
publisher
Informa Healthcare
external identifiers
  • wos:000361321700010
  • scopus:84940460241
ISSN
1502-7686
DOI
10.3109/00365513.2015.1066846
language
English
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yes
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7e43632c-1c3c-4c16-8c6a-acff7ef6482e (old id 8074253)
date added to LUP
2015-11-19 10:40:14
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2017-09-17 06:50:38
@article{7e43632c-1c3c-4c16-8c6a-acff7ef6482e,
  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 (&lt;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.},
  author       = {Gils, Charlotte and Ramanathan, Ramshanker and Breindahl, Torben and Brokner, Mette and Christiansen, Anne L. and Eng, Oyvin and Hammer, Ida J. and Herrera, Catherine B. and Jansen, Aina and Langsjoen, Eva C. and Lokkebo, Elisabeth S. and Osestad, Toril and Schroder, Anne D. and Walther, Lisa},
  issn         = {1502-7686},
  keyword      = {Natriuretic peptide,biological markers,heart disease,point-of-care,systems,validation studies},
  language     = {eng},
  number       = {7},
  pages        = {602--609},
  publisher    = {Informa Healthcare},
  series       = {Scandinavian Journal of Clinical & Laboratory Investigation},
  title        = {NT-proBNP on Cobas h 232 in point-of-care testing: Performance in the primary health care versus in the hospital laboratory},
  url          = {http://dx.doi.org/10.3109/00365513.2015.1066846},
  volume       = {75},
  year         = {2015},
}