Applications and regulatory of nanotechnology‐based innovative <i>in vitro</i> diagnostics

Chen, Kuan; Han, Houyu; Tuguntaev, Ruslan G.; Wang, Peirong; Guo, Weisheng; Huang, Jiayu; Gong, Xiaoqun; Liang, Xing‐Jie

doi:10.1002/viw.20200091

Cited by 12 publications

(6 citation statements)

References 62 publications

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“…From the perspective of diagnostic applications, the real‐time detection or monitoring is still challenging. [ 105 ] Especially, the mechanical properties of noble metal self‐assemblies should be considered when designing portable and wearable sensing devices for next‐generation POC diagnostics in resource‐limited areas. [ 106 ] In summary, we foresee that the rational design and development of noble metal self‐assemblies will bring far‐reaching implications to IVD in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Emerging Biosensors Based on Noble Metal Self‐Assembly for In Vitro Disease Diagnosis

Qian²,

Huang

2023

Advanced NanoBiomed Research

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The biosensing systems are powerful tools in characterizing the pathological state of patients, promising in vitro disease diagnosis at an early stage. Noble metals are introduced into emerging biosensors benefiting from their outstanding properties, such as surface plasmon resonance and photothermal conversion. The ordered arrangements of noble metals into superstructures through self‐assembling offer improved selectivity and sensitivity in biosensing disease biomarkers. Herein, the current strategies for preparing noble metal self‐assemblies are summarized, with particular emphasis on the driving forces triggering the assembling process. The functions that noble metal self‐assemblies exert in biosensing systems are then reviewed, highlighting their potential to be integrated into diagnostic applications. It is foreseen that noble metal self‐assembly brings far‐reaching implications in clinical diagnosis, serving as advanced tools to unlock the power of translational medicine.

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Section: Discussionmentioning

confidence: 99%

Emerging Biosensors Based on Noble Metal Self‐Assembly for In Vitro Disease Diagnosis

Qian²,

Huang

2023

Advanced NanoBiomed Research

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“…Advances have recently been reported in IVD with the rise of noble technologies in electrochemistry. Nanotechnology-based IVDs are widely available for disease diagnosis, and are highly sensitive, specific, and convenient [ 45 ]. Traditional medical devices are generally large-scale instruments, while IVDs are gaining increasing attention from researchers due to their convenience, rapidity in the diagnosis of biological samples.…”

Section: Biological Application Of Electrochemical Biosensorsmentioning

confidence: 99%

Point-of-care biochemical assays using electrochemical technologies: approaches, applications, and opportunities

et al. 2022

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Against the backdrop of hidden symptoms of diseases and limited medical resources of their investigation, in vitro diagnosis has become a popular mode of real-time healthcare monitoring. Electrochemical biosensors have considerable potential for use in wearable products since they can consistently monitor the physiological information of the patient. This review classifies and briefly compares commonly available electrochemical biosensors and the techniques of detection used. Following this, the authors focus on recent studies and applications of various types of sensors based on a variety of methods to detect common compounds and cancer biomarkers in humans. The primary gaps in research are discussed and strategies for improvement are proposed along the dimensions of hardware and software. The work here provides new guidelines for advanced research on and a wider scope of applications of electrochemical biosensors to in vitro diagnosis. Graphical abstract

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“…Therefore, the characterization of nanomaterials and their final products is a key link in determining their quality (MacCuspie, 2018). However, the characterization and quality control information of nanomaterials and their final products, as well as the characterization of the substance form during shedding and releasing over a time period provided in the registration applications, are insufficient (Chen et al, 2021). In addition, there is a lack of appropriate evaluation indicators, testing methods, and guidelines/standards for registered products.…”

Section: Plights Of Nanomedical Device Supervision In Chinamentioning

confidence: 99%

Market entry system considering the biosafety of nanomedical devices in China

Wen

Yang

Geng

2022

WIREs Nanomed Nanobiotechnol

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Our current knowledge on nanomaterials is mostly built on data from basic studies, and the application and developmental potentials of nanomaterials are emphasized. On the other hand, standard evaluation methods, models, exposure methods, standards, and guidelines for biological effect evaluation are inadequate. In response to the bottlenecks of supervision, scientific research institutes and regulatory organizations in China have cooperated closely to research and establish an evaluation system for nanomedical devices, and silver‐containing nanomaterials have been adopted as an example. In such a context, reference materials, characterization strategies, in vitro and in vivo distribution and toxicity evaluation standards have been established. This article highlights research on the risk assessment of nanomedical device products (taking silver‐containing nanomedical device products as an example) in China, including the characterization and release determination strategies, determination of nanosilver in tissues, applications of three‐dimensional skin models and in vitro and toxicity evaluation standards have been established. This article highlights research on technical standards. As a consequence, the “Guidelines for the safety and effectiveness evaluation of nanomedical devices” were published in 2021, and a market entry framework for nanomedical devices has been preliminarily formed as a significant component in scientific supervision. This Guideline supervises the review and supervision of nanomedical devices and, therefore, provides a guarantee for the market access of nanomedical devices in China.This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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Applications and regulatory of nanotechnology‐based innovative in vitro diagnostics

Cited by 12 publications

References 62 publications

Emerging Biosensors Based on Noble Metal Self‐Assembly for In Vitro Disease Diagnosis

Emerging Biosensors Based on Noble Metal Self‐Assembly for In Vitro Disease Diagnosis

Point-of-care biochemical assays using electrochemical technologies: approaches, applications, and opportunities

Market entry system considering the biosafety of nanomedical devices in China

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