Commercialized point-of-care technologies

Commercialized point-of-care technologies

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In this work, we shall attempt to review the status of PoC IVD as can be seen through commercialized applications alone, with a focus on handheld and small benchtop systems. The specific viewpoint is based on the technological and diagnostic target decisions of 104 PoC manufacturers that were selected on the basis of site visits on international trade fairs [10], PoC conferences, and market reports [11] for the PoC industry. The selection process for trade fair participation was the inclusion of any company offering a PoC solution on settings ranging from clinic to what is referred to as extreme PoC [12]. The scope of the selection is to get a comprehensive image of the commercialized PoC landscape, while minimizing bias in the inclusion process. Subsequently, we proceed to categorize the technologies used by each of these companies. We identify five major groups: (1) lateral-flow assays, (2) centrifugal microfluidics systems, (3) electrochemical systems, (4) nucleic acid testing systems, and (5) blood gas analyzers. Those five technological categories encompass 97 out of 104 companies, whereas 14 systems cannot be grouped into these categories. The technological groups are not strictly related to the sensing approach or the fluidic manipulation approach, rather in key design similarities. However, PoC systems are at the epicenter of a very active research field with new principles being applied constantly [13,14] that may very well render this categorization obsolete in the near future. In this sense, this article can be viewed as a snapshot of the commercial PoC landscape at the time of writing that is sure to evolve in coming years. Using as a starting point the previously mentioned 104 PoC firms, this review outlines the most prevalent technologies in the field and provides some insight on their functions, attributes, and limitations. Furthermore, using the same starting point, we present a thorough list of biomarkers that are currently the diagnostic objective of systems reviewed in this work.

Chapter Contents:

  • 14.1 Introduction
  • 14.2 Commercialized point-of-care systems - technology categorization
  • 14.2.1 Lateral-flow assays
  • LFIA principle of operation
  • Design, materials, and reagents in LFIA
  • Aspects of sensitivity and quantification in LFIAs
  • Multiplex analyses in LFIAs
  • 14.2.2 Centrifugal point-of-care systems
  • LOAD principle of operation
  • Design, materials, and reagents in LOAD
  • Aspects of sensitivity and precision in LOAD
  • Aspects of multiple measurements in LOAD
  • 14.2.3 Electrochemical sensing systems
  • Electrochemical sensing systems principles of operation
  • Design, materials, and reagents in electrochemical sensing systems
  • Performance of electrochemical PoC systems
  • 14.2.4 Nucleic acid testing systems
  • NAT principles of operation
  • NAT PoC systems performance
  • 14.2.5 Blood gas/ electrolyte benchtop systems
  • 14.2.6 Other technologies
  • Physical determination of biomarkers (coagulation)
  • Optical detection systems
  • 14.3 Commercialized point-of-care systems - biomarkers
  • 14.4 Conclusions
  • References

Inspec keywords: biosensors; blood; health care; microfluidics; patient diagnosis

Other keywords: nucleic acid testing systems; small benchtop systems; PoC IVD; electrochemical systems; handheld systems; lateral flow assays; commercialized point-of-care technologies; blood gas analyzers; centrifugal microfluidics systems; diagnostic target decisions

Subjects: Micromechanical and nanomechanical devices and systems; Patient diagnostic methods and instrumentation; MEMS and NEMS device technology; Biosensors; Biomedical measurement and imaging; Biosensors

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