Analytical performance of a single epitope B-type natriuretic peptide sandwich immunoassay on the Minicare platform for point-of-care diagnostics.
Pract Lab Med
; 15: e00119, 2019 May.
Article
em En
| MEDLINE
| ID: mdl-30984810
ABSTRACT
Point-of-care B-type natriuretic peptide (BNP) testing with adequate analytical performance has the potential to improve patient flow and provide primary care givers with easy-to-use advanced diagnostic tools in the management of heart failure. We present the analytical evaluation of the Minicare BNP immunoassay under development on the Minicare I-20 platform for point-of-care testing. Analytical performance was evaluated using EDTA venous whole blood, EDTA plasma and capillary whole blood. Method comparison with a lab-testing system was performed using samples from 187 patients. Normal values were determined based on 160 healthy adults, aging from 19 to 70 years. Limit of blank (LoB), limit of detection (LoD) were determined to be 3.3â¯ng/L, 5.8â¯ng/L. Limit of quantitation (LoQ) in whole blood at 20% and 10% coefficient of variation (CV) was foundâ¯<â¯9â¯ng/L and <30â¯ng/L respectively without significant differences between EDTA whole blood and EDTA plasma. Total CV was found to be from 6.7% to 9.7% for BNP concentrations between 92.6 and 3984â¯ng/L. The sample type comparison study demonstrated correlation coefficients between 0.97 and 0.99 with slopes between 1.03 and 1.09 between the different samples. Method comparison between Minicare BNP and Siemens ADVIA Centaur BNP demonstrated a correlation coefficient of 0.92 with a slope of 1.06. The 97.5% URL of a healthy population was calculated to be 72.6â¯ng/L. The Minicare BNP assay is a robust, easy-to-use and sensitive test for rapid determination of BNP concentrations that can be used in a near-patient setting.
Analytical performance; B-type natriuretic peptide; BNP, B-type Natriuretic Peptide; CI, confidence interval; CLSI, clinical laboratory standards institute; CV, coefficient of variation; Capillary blood; Diagnosis; EDTA, ethylene-diamine-tetraacetic acid; HAMA, human anti-mouse antibody; HF, heart failure; Heart failure; K2-EDTA, dipotassium ethylene-diamine-tetraacetic acid; Li-heparin, lithium heparin; LoB, limit of blank; LoD, limit of detection; LoQ, limit of quantitation; NP, Natriuretic Peptide; NYHA, New York Heart Association; POC, point-of-care; Point-of-care; RF, rheumatoid factor; RFID, radiofrequency identification; RT, room temperature; SD, standard deviation; URL, upper reference limit; fTIR, frustrated total internal reflection
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1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article