TY - JOUR
T1 - NT-proBNP on Cobas h 232 in point-of-care testing
T2 - Performance in the primary health care versus in the hospital laboratory
AU - Gils, Charlotte
AU - Ramanathan, Ramshanker
AU - Breindahl, Torben
AU - Brokner, Mette
AU - Christiansen, Anne L.
AU - Eng, Øyvin
AU - Hammer, Ida J.
AU - Herrera, Catherine B.
AU - Jansen, Aina
AU - Langsjøen, Eva C.
AU - Løkkebo, Elisabeth S.
AU - Osestad, Toril
AU - Schrøder, Anne D.
AU - Walther, Lisa
N1 - Publisher Copyright:
© 2015 Informa Healthcare.
PY - 2015/10/3
Y1 - 2015/10/3
N2 - 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.
AB - 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.
KW - biological markers
KW - heart disease
KW - Natriuretic peptide
KW - point-of-care systems
KW - validation studies
UR - http://www.scopus.com/inward/record.url?scp=84940460241&partnerID=8YFLogxK
U2 - 10.3109/00365513.2015.1066846
DO - 10.3109/00365513.2015.1066846
M3 - Journal article
C2 - 26305423
AN - SCOPUS:84940460241
SN - 0036-5513
VL - 75
SP - 602
EP - 609
JO - Scandinavian Journal of Clinical and Laboratory Investigation
JF - Scandinavian Journal of Clinical and Laboratory Investigation
IS - 7
ER -