Key result
The Minicare BNP point-of-care assay demonstrated strong analytical performance, with a correlation coefficient of 0.92 and a slope of 1.06 when compared to the Siemens ADVIA Centaur BNP lab-testing system.
Why the study?
Point-of-care BNP testing with adequate analytical performance could improve patient flow and provide primary care givers with diagnostic tools for heart failure management.
Does the Minicare BNP point-of-care immunoassay demonstrate adequate analytical performance compared to a standard lab-testing system?
Does the Minicare BNP point-of-care immunoassay demonstrate adequate analytical performance compared to a standard lab-testing system?
The Minicare BNP point-of-care immunoassay demonstrates robust analytical performance and high correlation with standard laboratory testing, supporting its potential use in near-patient settings for heart failure management.
May support point-of-care BNP testing; leaves open clinical outcome validation.
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 3.3 ng/L, 5.8 ng/L. Limit of quantitation (LoQ) in whole blood at 20% and 10% coefficient of variation (CV) was found < 9 ng/L and <30 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 3984 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 72.6 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.
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Reenen et al. (2019) studied Heart failure (diagnostic testing) (n=347). Minicare BNP immunoassay vs. Siemens ADVIA Centaur BNP was evaluated on Method comparison between Minicare BNP and Siemens ADVIA Centaur BNP (slope 1.06, correlation coefficient 0.92, 95% CI 0.98-1.12). The Minicare BNP point-of-care assay demonstrated strong analytical performance, with a correlation coefficient of 0.92 and a slope of 1.06 when compared to the Siemens ADVIA Centaur BNP lab-testing system.
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