Development and calibration of a new point-of-care test for the determination of NT-proBNP in whole blood

被引：0

作者：

Bertsch, Thomas

Dikkeschei, Bert

Gurr, Eberhard

Hayen, Wiebke

Jorgensen, Bo

Lotz, Johannes

Mueller-Bardorff, Margit

Ordonez-Llanos, Jordi

Schulz, Ilse

Spinke, Juergen

Thiele, Marcel

Zerback, Rainer ^{[1
]}

机构：

[1] Roche Diagnost GmbH, Evaluat Near Patient Testing, Dept DXR ED1, D-68305 Mannheim, Germany

[2] Klinikum Nurnberg, Inst Klin Chem, Nurnberg, Germany

[3] Klinikum Nurnberg, Lab Med, Nurnberg, Germany

[4] Isala Klin, Zwolle, Netherlands

[5] Zent Krankenhaus Links Weser, Abt Klin Chem & Zent Labor, Bremen, Germany

[6] Viborg Kjellerup Hosp, Dept Clin Biochem, Viborg, Denmark

[7] Univ Mainz, Inst Klin Chem, D-6500 Mainz, Germany

[8] Univ Klinikum Schleswig Holstein, Med Klin 2, Lubeck, Germany

[9] Roche Diagnost GmbH, Res & Dev Near Patient Testing, Mannheim, Germany

来源：

CLINICAL LABORATORY | 2007年 / 53卷 / 7-8期

关键词：

brain natriuretic peptide (BNP); calibration; congestive heart failure; CHF; natriuretic peptides; N-terminal proBNP (NT-proBNP); point-of-care testing; POCT; NATRIURETIC PEPTIDE; TROPONIN-T; QUANTITATIVE-DETERMINATION; ANALYTICAL PERFORMANCE; MULTICENTER EVALUATION; ASSAY; BNP; SYSTEM;

D O I：

暂无

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

A new point-of-care test for the determination of NT-proBNP in whole blood was developed based on the existing gold-label rapid immunoassay technology of the Roche Cardiac reader system. The novel gold-labelled monoclonal antibody recognizes NT-proBNP at amino acid sequence 27 to 31, the biotinylated polyclonal antibody recognizes sequence 39 to 50. In a model assay based upon the reference method Elecsys proBNP and with an R & D lot of the point-of-care test, this newly selected and developed combination of antibodies showed a very good correlation with the standard Elecsys proBNP assay with correlations of 0.96 or 0.94, respectively. The test was calibrated according to the existing masterlot concept of the Roche CARDIAC tests with Elecsys proBNP as a reference. In a preliminary method comparison with Elecsys proBNP the accuracy of the calibration was confirmed; the bias was between 1 and 6%. Possible reasons of approximately 1 % outliers (> +/- 100%) were discussed.

引用

页码：423 / 431

页数：9

共 13 条

[1]

Baum H, 2001, Clin Lab, V47, P549

[2] Analytical performance of the N terminal pro B type natriuretic peptide (NT-proBNP) assay on the Elecsys™ 1010 and 2010 analysers [J].