Analytical evaluation of a new point of care system for measuring cardiac Troponin I

Kemper, Danielle; Semjonow, Véronique; Theije, Femke de; Keizer, Diederick; Lippen, Lian van; Mair, Johannes; Wille, Bernadette; Christ, Michael; Geier, Felicitas; Hausfater, Pierre; Pariente, D.; Scharnhorst, Volkher; Curvers, Joyce; Nieuwenhuis, Jeroen H.

doi:10.1016/j.clinbiochem.2016.11.011

Cited by 28 publications

(14 citation statements)

References 16 publications

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“…Here, we demonstrate the analytical evaluation of the POC Minicare BNP assay under development, which runs on the Minicare I-20 platform with a turnaround time of less than 10 min (Fig. 1a) [8]. Aside from quantifying BNP from venous whole blood/plasma samples, Minicare BNP also accepts capillary whole blood samples from finger prick.…”

Section: Introductionmentioning

confidence: 99%

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

Reenen

Berger

Moreau

et al. 2019

Practical Laboratory Medicine

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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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Section: Introductionmentioning

confidence: 99%

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

Reenen

Berger

Moreau

et al. 2019

Practical Laboratory Medicine

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“…For example, the i-Stat or Philips Minicare I-20 can achieve a subpicomolar LOD (18,19). While these devices can be used for some applications, such as detection of elevated troponin in the case of a heart attack, low sensitivity limits the use of such devices for the screening of individuals for infectious disease through the detection of viral proteins.…”

Section: Discussionmentioning

confidence: 99%

Nanoswitch-linked immunosorbent assay (NLISA) for fast, sensitive, and specific protein detection

Hansen

Yang

Koussa

et al. 2017

Proc. Natl. Acad. Sci. U.S.A.

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Protein detection and quantification play critical roles in both basic research and clinical practice. Current detection platforms range from the widely used ELISA to more sophisticated, and more expensive, approaches such as digital ELISA. Despite advances, there remains a need for a method that combines the simplicity and cost-effectiveness of ELISA with the sensitivity and speed of modern approaches in a format suitable for both laboratory and rapid, point-of-care applications. Building on recent developments in DNA structural nanotechnology, we introduce the nanoswitch-linked immunosorbent assay (NLISA), a detection platform based on easily constructed DNA nanodevices that change conformation upon binding to a target protein with the results read out by gel electrophoresis. NLISA is surface-free and includes a kinetic-proofreading step for purification, enabling both enhanced sensitivity and reduced cross-reactivity. We demonstrate femtomolar-level detection of prostate-specific antigen in biological fluids, as well as reduced cross-reactivity between different serotypes of dengue and also between a single-mutation and wildtype protein. NLISA is less expensive, uses less sample volume, is more rapid, and, with no washes, includes fewer hands-on steps than ELISA, while also achieving superior sensitivity. Our approach also has the potential to enable rapid point-of-care assays, as we demonstrate by performing NLISA with an iPad/ iPhone camera for imaging.biodetection | point of care | DNA nanotechnology | molecular self-assembly P rotein quantification plays a significant role in a wide range of clinical and research applications, from detecting Zika virus infection (1), to ascertaining the presence of a heart attack (2), to finding trace amounts of allergens in food products (3). Over the years, a variety of detection platforms have emerged, from the traditional sandwich ELISA (4), to more sophisticated and costly approaches such as digital ELISA (5). However, the need remains for an approach that combines the simplicity and cost-effectiveness of ELISA, which remains widespread due to these advantages, with the improvements in sensitivity and speed of modern approaches-ideally in a format suitable for both laboratory and rapid, point-of-care applications. One promising strategy, based on recent developments in DNA structural nanotechnology, has been the development of programmable reagents capable of sensing, responding, and reporting changes in their local environments. These include tension gauge tethers to measure the forces required to activate signaling through a ligand-receptor bond (6), toehold switches for paper-based synthetic gene networks (7), nanocalipers to probe nucleosome stability (8), and nanoactuators that can propagate distance changes (9). Proof-of-principle experiments of protein detection using self-assembled DNA nanodevices that undergo changes in shape to report the binding of molecular targets have recently been demonstrated (10, 11), although widespread use of these approaches has b...

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“…Moreover, recent reports support the implementation of POCT for rapid rule-in/rule-out of AMI due to comparable performances to hs-cTnI assays, with one such study demonstrating that the PATHFAST cTnI-II can be considered a hs-cTnI assay [15,18]. These highly impressive characteristics are not observed in the majority of POC platforms for cTn measurements, with significant cTn measurement discordance between POC platforms in addition to the prevalence of false positive and false negative readings [46,103,230]. The challenge for MIPs in influencing the development of POC platforms for cTn measurements is that common features, such as their low cost, rapid synthesis and long-term stability become extraneous in acute settings where sensitivity and a rapid response are imperative.…”

Section: Mips For Point-of-care Testingmentioning

confidence: 99%

Evaluation of Molecularly Imprinted Polymers for Point-of-Care Testing for Cardiovascular Disease

Regan

Walsh

O’Kennedy

et al. 2019

Sensors

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Molecular imprinting is a rapidly growing area of interest involving the synthesis of artificial recognition elements that enable the separation of analyte from a sample matrix and its determination. Traditionally, this approach can be successfully applied to small analyte (<1.5 kDa) separation/ extraction, but, more recently it is finding utility in biomimetic sensors. These sensors consist of a recognition element and a transducer similar to their biosensor counterparts, however, the fundamental distinction is that biomimetic sensors employ an artificial recognition element. Molecularly imprinted polymers (MIPs) employed as the recognition elements in biomimetic sensors contain binding sites complementary in shape and functionality to their target analyte. Despite the growing interest in molecularly imprinting techniques, the commercial adoption of this technology is yet to be widely realised for blood sample analysis. This review aims to assess the applicability of this technology for the point-of-care testing (POCT) of cardiovascular disease-related biomarkers. More specifically, molecular imprinting is critically evaluated with respect to the detection of cardiac biomarkers indicative of acute coronary syndrome (ACS), such as the cardiac troponins (cTns). The challenges associated with the synthesis of MIPs for protein detection are outlined, in addition to enhancement techniques that ultimately improve the analytical performance of biomimetic sensors. The mechanism of detection employed to convert the analyte concentration into a measurable signal in biomimetic sensors will be discussed. Furthermore, the analytical performance of these sensors will be compared with biosensors and their potential implementation within clinical settings will be considered. In addition, the most suitable application of these sensors for cardiovascular assessment will be presented.

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Analytical evaluation of a new point of care system for measuring cardiac Troponin I

Abstract: The Minicare cTnI assay is a sensitive and precise, clinical usable test for determination of cTnI concentration that can be used in a near-patient setting as an aid in the diagnosis of acute myocardial infarction.

Cited by 28 publications

References 16 publications

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

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

Nanoswitch-linked immunosorbent assay (NLISA) for fast, sensitive, and specific protein detection

Evaluation of Molecularly Imprinted Polymers for Point-of-Care Testing for Cardiovascular Disease

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