Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications

Patou, François; Alatraktchi, Fatima AlZahra’a; Kjægaard, Claus; Madsen, Jan; Svendsen, Winnie Edith

doi:10.3390/diagnostics6030033

Cited by 12 publications

(6 citation statements)

References 54 publications

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“…We undertook the MBSD of a biosensing platform introduced in Patou et al . Our Modular Diagnostics platform aims to allow the detection of various biological molecular markers at Point‐of‐Care (POC), that is, field medical diagnostics.…”

Section: Case: Nanowire Biosensor and Instrumentation System For Measmentioning

confidence: 99%

Model‐based systems engineering for life‐sciences instrumentation development

Patou

Maier

Svendsen

et al. 2018

Systems Engineering

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Next-generation genome sequencing machines and Point-of-Care (PoC) in vitro diagnostics devices are precursors of an emerging class of Cyber-Physical Systems (CPS), one that harnesses biomolecular-scale mechanisms to enable novel "wet-technology" applications in medicine, biotechnology, and environmental science. Although many such applications exist, testifying the importance of innovative life-sciences instrumentation, recent events have highlighted the difficulties that designing organizations face in their attempt to guarantee safety, reliability, and performance of this special class of CPS. New regulations and increasing competition pressure innovators to rethink their design and engineering practices, and to better address the above challenges. The pace of innovation will be determined by how organizations manage to ensure the satisfaction of aforementioned constraints while also streamlining product development, maintaining high cost-efficiency and shortening time-to-market. Model-Based Systems Engineering provides a valuable framework for addressing these challenges. In this paper, we demonstrate that existing and readily available model-based development frameworks can be adopted early in the life-sciences instrumentation design process. Such frameworks are specifically helpful in describing and characterizing CPS including elements of a biological nature both at the architectural and performance level. We present the SysML model of a smartphone-based PoC diagnostics system designed for detecting a particular molecular marker. By modeling components and behaviors spanning across the biological, physical-nonbiological, and computational domains, we were able to characterize the important systemic relations involved in the specification of our system's Limit of Detection. Our results illustrate the suitability of such an approach and call for further work toward formalisms enabling the formal verification of systems including biomolecular components. K E Y W O R D Scyber-physical systems, life-sciences, model-based systems engineering, model-based systems design, sensitivity analysis, SysML 98

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Section: Case: Nanowire Biosensor and Instrumentation System For Measmentioning

confidence: 99%

Model‐based systems engineering for life‐sciences instrumentation development

Patou

Maier

Svendsen

et al. 2018

Systems Engineering

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“…Diagnostic tests are usually drawn up anew according to the characteristics of a specific issue. It has been argued that creating reprogrammable basal platforms could save both development costs and time . Conception of such platforms is challenging because they must be able to support different samples, reagents and sensing modes.…”

Section: Integrationmentioning

confidence: 99%

Innovative technologies for point‐of‐care testing of viral hepatitis in low‐resource and decentralized settings

Duchesne

Lacombe

2017

Journal of Viral Hepatitis

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According to the Global Burden of Diseases, chronic viral hepatitis B and C are one of the most challenging global health conditions that rank among the first causes of morbidity and mortality worldwide. Low- and middle-income countries are particularly affected by the health burden associated with HBV or HCV infection. One major gap in efficiently addressing the issue of viral hepatitis is universal screening. However, the costs and chronic lack of human resources for using traditional screening strategies based on serology and molecular biology preclude any scaling-up. Point-of-care tests have been deemed a powerful potential solution to fill the current diagnostics gap in low-resource and decentralized settings. Despite high interest resulting from their development in recent years, very few point-of-care devices have reached the market. Scaling down and automating all testing steps in 1 single device (eg, sample preparation, detection and readout) is indeed challenging. But innovations in multiple disciplines such as nanotechnologies, microfluidics, biosensors and synthetic biology have led to the creation of chip-sized laboratory systems called "lab-on-a-chip" devices. This review aims to explain how these innovations can overcome technological barriers that usually arise for each testing step while developing integrated point-of-care tests. Point-of-care test prototypes rarely meet the requirements for mass production, which also hinders their large-scale production. In addition to logistical hurdles, legal and economic constraints specific to the commercialization of in vitro diagnostics, which have also participated in the low transfer of innovative point-of-care tests to the field, are discussed.

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“…Several groups have already thoroughly documented the benefits of small cross-sectional SiNW channels or of biasing the sensor in the subthreshold regime [12], [13]. Although these investigations and experimental validation studies are sufficiently informative for many applications, they are limited in addressing the likely scenario of the integration of SiNWbioFETs in a custom-built diagnostics system such as the one we introduced in [14]. Indeed, the SiNW-bioFET design and operation specifications that promise the greatest LoD performances are also those that are the most challenging from an instrumentation perspective.…”

Section: Introductionmentioning

confidence: 99%

System-Level Sensitivity Analysis of SiNW-bioFET-Based Biosensing Using Lock-In Amplification

et al. 2017

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Abstract-Although Silicon Nanowire biological Field-Effect Transistors (SiNW-bioFETs) have steadily demonstrated their ability to detect biological markers at ultra-low concentration, they have not yet translated into routine diagnostics applications. One of the challenges inherent to the technology is that it requires an instrumentation capable of recovering ultra-low signal variations from sensors usually designed and operated in a highly-resistive configuration. Often overlooked, the SiNWbioFET/instrument interactions are yet critical factors in determining overall system biodetection performances.Here, we carry out for the first time the system-level sensitivity analysis of a generic SiNW-bioFET model coupled to a custom-design instrument based on the lock-in amplifier. By investigating a large parametric space spanning over both sensor and instrumentation specifications, we demonstrate that systemwide investigations can be instrumental in identifying the design trade-offs that will ensure the lowest Limits-of-Detection. The generic character of our analytical model allows us to elaborate on the most general SiNW-bioFET/instrument interactions and their overall implications on detection performances. Our model can be adapted to better match specific sensor or instrument designs to either ensure that ultra-high sensitivity SiNW-bioFETs are coupled with an appropriately sensitive and noise-rejecting instrumentation, or to best tailor SiNW-bioFET design to the specifications of an existing instrument.

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Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications

Cited by 12 publications

References 54 publications

Model‐based systems engineering for life‐sciences instrumentation development

Model‐based systems engineering for life‐sciences instrumentation development

Innovative technologies for point‐of‐care testing of viral hepatitis in low‐resource and decentralized settings

System-Level Sensitivity Analysis of SiNW-bioFET-Based Biosensing Using Lock-In Amplification

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