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

被引:11
|
作者
Gils, Charlotte [1 ]
Ramanathan, Ramshanker [2 ,3 ]
Breindahl, Torben [4 ]
Brokner, Mette [5 ]
Christiansen, Anne L. [1 ]
Eng, Oyvin [6 ]
Hammer, Ida J. [7 ]
Herrera, Catherine B. [8 ]
Jansen, Aina [9 ]
Langsjoen, Eva C. [10 ]
Lokkebo, Elisabeth S. [11 ]
Osestad, Toril [12 ]
Schroder, Anne D. [13 ]
Walther, Lisa [14 ]
机构
[1] Odense Univ Hosp, Dept Clin Biochem & Pharmacol, DK-5000 Odense, Denmark
[2] Hosp South West Denmark, Dept Clin Biochem, Esbjerg, Denmark
[3] Univ Southern Denmark, Inst Publ Hlth, Unit Thrombosis Res, Odense, Denmark
[4] Aalborg Univ, Vendsyssel Hosp, Dept Clin Biochem, Hjorring, Denmark
[5] Vestfold Hosp Trust, Cent Lab, Tonsberg, Norway
[6] Haukeland Hosp, Hormone Lab, N-5021 Bergen, Norway
[7] Haukeland Hosp, Clin Chem Lab, N-5021 Bergen, Norway
[8] Akershus Univ Hosp, Dept Diagnost & Technol, Loerenskog, Norway
[9] Innlandet Hosp Trust, Dept Clin Biochem, Lillehammer, Norway
[10] Akershus Univ Hosp, Unit Med Biochem, Div Diagnost & Technol, Lorenskog, Norway
[11] Norwegian Qual Improvement Primary Hlth Care Labs, Bergen, Norway
[12] Sorlandet Hosp, Dept Med Biochem, Kristiansand, Norway
[13] Aarhus Univ Hosp, Dept Clin Biochem, Aarhus, Denmark
[14] Univ Lund Hosp, Dept Lab Med, Lund, Sweden
关键词
Natriuretic peptide; biological markers; heart disease; point-of-care systems; validation studies; CHRONIC HEART-FAILURE; NATRIURETIC PEPTIDE; BIOLOGICAL VARIATION; BNP; DIAGNOSIS; ASSAY; SYSTEM; IMPACT; PHASE; AGE;
D O I
10.3109/00365513.2015.1066846
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:602 / 609
页数:8
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