Analytical performance of a single epitope B-type natriuretic peptide sandwich immunoassay on the Minicare platform for point-of-care diagnostics

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 3.3 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.

BNP/NT-proBNP in pulmonary arterial hypertension: time for point-of-care testing?

“…High sensitivity of both clinical and POCT BNP assays at ∼100 ng•L −1 has been reported [115]. In PAH risk stratification, the ESC/ERS guideline threshold values are higher: BNP: low <50 ng Capillary samples have been shown to offer good correlation with venous samples in several studies ranging from 111 to 187 patients each [60,93], as well as acceptable reproducibility [117]. Further research is required to identify whether the specific pathophysiology of PAH affects the synthesis and secretion of biomarker molecules, and hence the reliability of BNP/NT-proBNP as a biomarker in capillary samples, especially in the context of physical exertion before sampling.…”

“…In patients with LV dysfunction, for example, there are multiple studies to show POCT assays are comparable to clinical laboratory assays when using the same antibodies and materials [85,86]. Device-specific studies of BNP/NT-proBNP POCT include: Triage BNP (Quidel; San Diego, CA, USA) [87,88]; RAMP NT-proBNP (Response Biomedical; Vancouver, Canada) [89]; cobas h232 (Roche Diagnostics) [90][91][92]; Minicare BNP (Philips; Eindhoven, The Netherlands) [93]; i-STAT (Abbott; Princeton, NJ, USA), which studies noted had good agreement with clinical laboratory despite low precision [88,94]; PATHFAST NT-proBNP (Mitsubishi Chemical Europe; Düsseldorf, Germany) [95,96]; AQT90 FLEX (Radiometer; Copenhagen, Denmark) [97]; Alere NT-proBNP (now Quidel) [98] and Alere Heart Check, although lower precision than clinical laboratory was noted [60,84,99]; Rapidpia (Sekisui Medical Co.; Tokyo, Japan) [100]; and SHIONOSPOT (Shionogi & Co.; Osaka, Japan) [100] (table 3). POCT assays also typically have a narrower analytical range than clinical laboratory assays, and this may limit their utility in patients with extreme values [66].…”

“…•L −1 , intermediate 50-300 ng•L −1 , high >300 ng•L −1 ; NT-proBNP: low <300 ng•L −1 , intermediate 300-1400 ng•L −1 , high >1400 ng•L −1 [1]. REVEAL 2.0 has similar thresholds (BNP: low <50 ng•L −1 , intermediate 200-800 ng•L −1 , high ⩾800 ng•L −1 ; NT-proBNP: low <300 ng•L −1 , high ⩾1100 ng•L −1 ) [9], though both scores are comfortably within the analytical range of available POCT devices[60,84,[87][88][89][90][91][92][93][94][95][96][97][98][99][100]116].…”

Recent advances in cardiac biomarkers detection: From commercial devices to emerging technologies

“…A detection antibody (mAB Ab-BNP2) then recognizes the whole immune complex formed by the BNP and the capture antibody (Figure 4). The specificity of the detection of the BNP with this technology is very high because the detection antibody is specific to the whole immune complex [131][132][133]. For the detection of BNP in a blood sample, the Minicare device has the following performances: a LoB of 3.3 ng/L, a LoD of 5.8 ng/L and a LoQ lower than 9ng/L at a CV of 20% and lower than 30 ng/L at a CV of 10% [131].…”

A Novel Redox‐free Immunosensor Concept Based on Cobalt Phthalocyanine@carbon Nanotubes Pseudocapacitor for Cardiac B‐type Natriuretic Peptide Detection

“…Given the nanotechnology advances, new emerging technologies constructed on the electrochemical screen‐printed electrode have gained particular attention as an essential analytical tool due to their portability, sensitivity and rapid responses, besides the advantages of large‐scale production with low‐cost [12, 13]. Some approaches based on screen‐printed electrodes have been developed for the BNP [14]. Although these electrochemical immunosensors with label‐free detection have achieved significant results, the necessity of redox probe solutions for current responses, like the ferri/ferrocyanide potassium in voltammetric measurements are some inconveniences.…”