Point-of-care devices for pathogen detections: The three most important factors to realise towards commercialization

Abstract The development of lab-on-a-chip technology and its applications in biochemical and biomedical analyses has, during the last two decades, led to the potential realisation of portable and on-site detection devices, the so-called point-of-care (PoC) detection systems. These are essentially cheap, easy-to-handle systems, offering rapid sample-to-answer results to non-technical operators. In this perspective, we do not review all the current advances of Lab-on-a-chip techniques for the realisation of PoC. Instead, we aim to provide insight into what we foresee as the three most important factors to play the essential roles for succeeding in making commercially viable PoC pathogen-detection devices. The three insights are namely: the utilizations of (i) disposable polymer (microfluidic) chips, (ii) the implementation of surface-bound (or solid-phase) nucleic-acid amplification techniques and (iii) relying (more) on open-source hardware and software.

[1]  Donald E Ingber,et al.  Optimization of Pathogen Capture in Flowing Fluids with Magnetic Nanoparticles. , 2015, Small.

[2]  John R Lake,et al.  Low-cost feedback-controlled syringe pressure pumps for microfluidics applications , 2017, PloS one.

[3]  Donald E Ingber,et al.  An extracorporeal blood-cleansing device for sepsis therapy , 2014, Nature Medicine.

[4]  Virginia Chu,et al.  Multiplexed microfluidic fluorescence immunoassay with photodiode array signal acquisition for sub-minute and point-of-need detection of mycotoxins. , 2018, Lab on a chip.

[5]  A. Wolff,et al.  Optimising the supercritical angle fluorescence structures in polymer microfluidic biochips for highly sensitive pathogen detection: a case study on Escherichia coli. , 2019, Lab on a chip.

[6]  H. Tom Soh,et al.  High-throughput, temperature-controlled microchannel acoustophoresis device made with rapid prototyping , 2012 .

[7]  T. Q. Hung,et al.  A lab-on-a-chip system with integrated sample preparation and loop-mediated isothermal amplification for rapid and quantitative detection of Salmonella spp. in food samples. , 2015, Lab on a chip.

[8]  Jacques Schrenzel,et al.  Robustness of a loop-mediated isothermal amplification reaction for diagnostic applications. , 2011, FEMS immunology and medical microbiology.

[9]  G. Whitesides,et al.  Rapid Prototyping of Microfluidic Systems in Poly(dimethylsiloxane). , 1998, Analytical chemistry.

[10]  J. Schrenzel,et al.  Bench-to-bedside review: Rapid molecular diagnostics for bloodstream infection - a new frontier? , 2012, Critical Care.

[11]  Li Zhang,et al.  Rapid detection of pathogens using antibody-coated microbeads with bioluminescence in microfluidic chips , 2010, Biomedical microdevices.

[12]  C. Henry,et al.  Plasma Modification of PDMS Microfluidic Devices for Control of Electroosmotic Flow , 2007 .

[13]  T. Notomi,et al.  Loop-mediated isothermal amplification of DNA. , 2000, Nucleic acids research.

[14]  P. Craw,et al.  Isothermal nucleic acid amplification technologies for point-of-care diagnostics: a critical review. , 2012, Lab on a chip.

[15]  Anders Wolff,et al.  Rapid detection of avian influenza virus in chicken fecal samples by immunomagnetic capture reverse transcriptase-polymerase chain reaction assay. , 2011, Diagnostic microbiology and infectious disease.

[16]  John Irwin,et al.  Life-cycle economic analysis of distributed manufacturing with open-source 3-D printers , 2013, Mechatronics.

[17]  Sune Zoëga Andreasen Towards a fully automated lab-on-a-disc system integrating sample enrichment and detection of analytes from complex matrices , 2017 .

[18]  Fatimah Ibrahim,et al.  A microfluidic lab-on-a-disc integrated loop mediated isothermal amplification for foodborne pathogen detection , 2016 .

[19]  A. Roda,et al.  Integrating biochemiluminescence detection on smartphones: mobile chemistry platform for point-of-need analysis. , 2014, Analytical chemistry.

[20]  Suguru Takeuchi,et al.  Assessment of the loop-mediated isothermal amplification assay for rapid diagnosis of Mycoplasma pneumoniae in pediatric community-acquired pneumonia. , 2013, Japanese journal of infectious diseases.

[21]  Da Xing,et al.  Segmented continuous-flow multiplex polymerase chain reaction microfluidics for high-throughput and rapid foodborne pathogen detection. , 2014, Analytica chimica acta.

[22]  G. Whitesides The origins and the future of microfluidics , 2006, Nature.

[23]  Seung-Chan Hong,et al.  Continuous aerosol size separator using inertial microfluidics and its application to airborne bacteria and viruses. , 2015, Lab on a chip.

[24]  Noor Faizah Mohd-Naim,et al.  From market to food plate: Current trusted technology and innovations in halal food analysis , 2016 .

[25]  P. B. Vander Horn,et al.  A novel strategy to engineer DNA polymerases for enhanced processivity and improved performance in vitro. , 2004, Nucleic acids research.

[26]  Hywel Morgan,et al.  Simple and rapid sample preparation system for the molecular detection of antibiotic resistant pathogens in human urine , 2016, Biomedical microdevices.

[27]  Terry Kientz,et al.  A portable, integrated analyzer for microfluidic – based molecular analysis , 2011, Biomedical microdevices.

[28]  Tamara Matute,et al.  Low cost and open source multi-fluorescence imaging system for teaching and research in biology and bioengineering , 2017, PloS one.

[29]  Alison M. Cupples,et al.  DNA extraction-free quantification of Dehalococcoides spp. in groundwater using a hand-held device. , 2014, Environmental science & technology.

[30]  Joshua M. Pearce,et al.  Open-Source 3D-Printable Optics Equipment , 2013, PloS one.

[31]  Aghiad Ghazal,et al.  Recent advances in X-ray compatible microfluidics for applications in soft materials and life sciences. , 2016, Lab on a chip.

[32]  Valerie Mioulet,et al.  Development and Initial Results of a Low Cost, Disposable, Point-of-Care Testing Device for Pathogen Detection , 2011, IEEE Transactions on Biomedical Engineering.

[33]  J. Sturm,et al.  Materials Aspects in Micro- and Nanofluidic Systems Applied to Biology , 2006 .

[34]  Blake Hannaford,et al.  Raven-II: An Open Platform for Surgical Robotics Research , 2013, IEEE Transactions on Biomedical Engineering.

[35]  Matthias Landgraf,et al.  A Cartesian Coordinate Robot for Dispensing Fruit Fly Food , 2018 .

[36]  Li Zhang,et al.  Loop-mediated isothermal amplification (LAMP): A novel rapid detection platform for pathogens. , 2017, Microbial pathogenesis.

[37]  Mohammad-Ali Shahbazi,et al.  Microfluidic devices for sample preparation and rapid detection of foodborne pathogens. , 2018, Biotechnology advances.

[38]  Mark Shephard Oam A Practical Guide to Global Point-of-Care Testing , 2016 .

[39]  Benjamin Schuler,et al.  Microfluidic mixer designed for performing single-molecule kinetics with confocal detection on timescales from milliseconds to minutes , 2013, Nature Protocols.

[40]  Emanuel Carrilho,et al.  Comparison of the analytical performance of electrophoresis microchannels fabricated in PDMS, glass, and polyester‐toner , 2008, Electrophoresis.

[41]  P. Glenn Gulak,et al.  Rapid Bacterial Detection via an All-Electronic CMOS Biosensor , 2016, PloS one.

[42]  Holger Becker,et al.  Polymer microfabrication technologies for microfluidic systems , 2008, Analytical and bioanalytical chemistry.

[43]  Sabrina Conoci,et al.  PCR Technologies for Point of Care Testing: Progress and Perspectives. , 2017, ACS sensors.

[44]  Lucia L Prieto-Godino,et al.  The €100 lab: A 3D-printable open-source platform for fluorescence microscopy, optogenetics, and accurate temperature control during behaviour of zebrafish, Drosophila, and Caenorhabditis elegans , 2017, PLoS biology.

[45]  Tae Seok Seo,et al.  Centrifugal loop-mediated isothermal amplification microdevice for rapid, multiplex and colorimetric foodborne pathogen detection. , 2016, Biosensors & bioelectronics.

[46]  Hadi Shafiee,et al.  Emerging Loop-Mediated Isothermal Amplification-Based Microchip and Microdevice Technologies for Nucleic Acid Detection. , 2016, ACS biomaterials science & engineering.

[47]  Weili Chen,et al.  Multiplexed detection of infectious diseases with microfluidic loop-mediated isothermal amplification and a smartphone , 2017, 2017 IEEE Healthcare Innovations and Point of Care Technologies (HI-POCT).

[48]  Myung-Suk Chun,et al.  Fabrication and validation of a multi-channel type microfluidic chip for electrokinetic streaming potential devices. , 2006, Lab on a chip.

[49]  William Plowden The Compact , 2003 .

[50]  G. G. Stokes "J." , 1890, The New Yale Book of Quotations.

[51]  Jeng-Rong Ho,et al.  Fabrication of PDMS (polydimethylsiloxane) microlens and diffuser using replica molding , 2006 .

[52]  Gang Li,et al.  A microfluidic droplet digital PCR for simultaneous detection of pathogenic Escherichia coli O157 and Listeria monocytogenes. , 2015, Biosensors & bioelectronics.

[53]  T. Laurell,et al.  Integrated Acoustic Separation, Enrichment, and Microchip Polymerase Chain Reaction Detection of Bacteria from Blood for Rapid Sepsis Diagnostics. , 2016, Analytical chemistry.

[54]  A. Föhrenbach,et al.  SIMPLE++ , 2000, OR Spectr..

[55]  Yi Zhang,et al.  Catching bird flu in a droplet , 2007, Nature Medicine.

[56]  Lisa J. Lapidus,et al.  Complete Procedure for Fabrication of a Fused Silica Ultrarapid Microfluidic Mixer Used in Biophysical Measurements , 2017, Micromachines.

[57]  Maggie R. Williams,et al.  Thirty-minute screening of antibiotic resistance genes in bacterial isolates with minimal sample preparation in static self-dispensing 64 and 384 assay cards , 2015, Applied Microbiology and Biotechnology.

[58]  Ks Shilpashree,et al.  Implementation of Image Processing on Raspberry Pi , 2015 .

[59]  S. S. Olmsted,et al.  Requirements for high impact diagnostics in the developing world , 2006, Nature.

[60]  Sang Joon John Lee,et al.  Microfabrication for Microfluidics , 2010 .

[61]  Microfluidic Mixers for Studying Protein Folding , 2012, Journal of visualized experiments : JoVE.

[62]  T. Q. Hung,et al.  Miniaturization of a micro-optics array for highly sensitive and parallel detection on an injection moulded lab-on-a-chip. , 2015, Lab on a chip.

[63]  A. Wolff,et al.  Rapid detection of Salmonella enterica in food samples by a novel approach with combination of sample concentration and direct PCR. , 2019, Biosensors & bioelectronics.

[64]  H. N. Hansen,et al.  Injection and injection-compression moulding replication capability for the production of polymer lab-on-a-chip with nano structures , 2017 .

[65]  Edwin E. Geldreich,et al.  Bacterial Colonization of Point-of-Use Water Treatment Devices , 1985 .

[66]  T. Q. Hung,et al.  A novel lab-on-chip platform with integrated solid phase PCR and Supercritical Angle Fluorescence (SAF) microlens array for highly sensitive and multiplexed pathogen detection. , 2017, Biosensors & bioelectronics.

[67]  M. J. Soares,et al.  Development of a magnetic separation method to capture sepsis associated bacteria in blood. , 2016, Journal of microbiological methods.

[68]  Niels Bent Larsen,et al.  Fast prototyping of injection molded polymer microfluidic chips , 2009 .

[69]  P. Mandal,et al.  Methods for Rapid Detection of Foodborne Pathogens: An Overview , 2011 .

[70]  Ming Lei,et al.  Hard and soft micromachining for BioMEMS: review of techniques and examples of applications in microfluidics and drug delivery. , 2004, Advanced drug delivery reviews.

[71]  J. Gooding,et al.  Brief review of monitoring methods for loop-mediated isothermal amplification (LAMP). , 2014, Biosensors & bioelectronics.

[72]  Xiao Zhi,et al.  A novel HBV genotypes detecting system combined with microfluidic chip, loop-mediated isothermal amplification and GMR sensors. , 2014, Biosensors & bioelectronics.

[73]  Haiping Wu,et al.  Multiplex loop-mediated isothermal amplification detection by sequence-based barcodes coupled with nicking endonuclease-mediated pyrosequencing. , 2012, Analytical chemistry.

[74]  D. Issadore,et al.  Microfluidic diafiltration-on-chip using an integrated magnetic peristaltic micropump. , 2017, Lab on a chip.

[75]  Barry W. Boehm,et al.  A spiral model of software development and enhancement , 1986, Computer.

[76]  Yan Wang,et al.  Loop-Mediated Isothermal Amplification Label-Based Gold Nanoparticles Lateral Flow Biosensor for Detection of Enterococcus faecalis and Staphylococcus aureus , 2017, Front. Microbiol..

[77]  Anders Wolff,et al.  A Complete Protocol for Rapid and Low-Cost Fabrication of Polymer Microfluidic Chips Containing Three-Dimensional Microstructures Used in Point-of-Care Devices , 2019, Micromachines.

[78]  E. Graham,et al.  Rapid and sensitive insulated isothermal PCR for point-of-need feline leukaemia virus detection , 2017, Journal of feline medicine and surgery.

[79]  G. Khanarian Optical properties of cyclic olefin copolymers , 2001 .

[80]  Robert D Stedtfeld,et al.  A polymer microfluidic chip for quantitative detection of multiple water- and foodborne pathogens using real-time fluorogenic loop-mediated isothermal amplification , 2012, Biomedical microdevices.

[81]  Uwadiae Obahiagbon,et al.  A compact, low-cost, quantitative and multiplexed fluorescence detection platform for point-of-care applications. , 2018, Biosensors & bioelectronics.

[82]  Deborah J. Mayhew,et al.  The usability engineering lifecycle , 1999, CHI Extended Abstracts.

[83]  Henrik Flyvbjerg,et al.  Directed self-organization of single DNA molecules in a nanoslit via embedded nanopit arrays , 2009, Proceedings of the National Academy of Sciences.

[84]  J. Jung,et al.  An integrated passive micromixer-magnetic separation-capillary electrophoresis microdevice for rapid and multiplex pathogen detection at the single-cell level. , 2011, Lab on a chip.

[85]  A. Manz,et al.  Miniaturized total chemical analysis systems: A novel concept for chemical sensing , 1990 .

[86]  Anders Kristensen,et al.  Injection molded nanofluidic chips: fabrication method and functional tests using single-molecule DNA experiments. , 2011, Lab on a chip.

[87]  S. Pennathur,et al.  Improving fluorescence detection in lab on chip devices. , 2008, Lab on a chip.

[88]  Andreas Manz,et al.  Single-molecule fluorescence detection in microfluidic channels—the Holy Grail in μTAS? , 2005, Analytical and bioanalytical chemistry.

[89]  M. Miyauchi,et al.  Low-reflective and super-hydrophilic properties of titanate or titania nanotube thin films via layer-by-layer assembly , 2006 .

[90]  Rashid Bashir,et al.  On-chip parallel detection of foodborne pathogens using loop-mediated isothermal amplification , 2013, Biomedical Microdevices.

[91]  Anders Wolff,et al.  From Lab on a Chip to Point of Care Devices: The Role of Open Source Microcontrollers , 2018, Micromachines.

[92]  J. Walsh,et al.  Evaluation of ten oral fluid point-of-collection drug-testing devices. , 2007, Journal of analytical toxicology.

[93]  Chia-Wen Tsao,et al.  Polymer Microfluidics: Simple, Low-Cost Fabrication Process Bridging Academic Lab Research to Commercialized Production , 2016, Micromachines.

[94]  T. Welty,et al.  Point-of-Care Testing: An Introduction , 2004, The Annals of pharmacotherapy.

[95]  Liang Qiao,et al.  Detection of Pathogenic Microorganisms by Microfluidics Based Analytical Methods. , 2018, Analytical chemistry.

[96]  Daniel C Leslie,et al.  A microdevice for rapid optical detection of magnetically captured rare blood pathogens. , 2014, Lab on a chip.

[97]  Julio Raba,et al.  Microfluidic immunosensor with micromagnetic beads coupled to carbon-based screen-printed electrodes (SPCEs) for determination of Botrytis cinerea in tissue of fruits. , 2010, Journal of agricultural and food chemistry.

[98]  Jin-Woo Choi,et al.  Disposable smart lab on a chip for point-of-care clinical diagnostics , 2004, Proceedings of the IEEE.

[99]  Sandeep Kumar Vashist,et al.  Point-of-Care Diagnostics: Recent Advances and Trends , 2017, Biosensors.

[100]  Stephen T C Wong,et al.  A lab-on-a-chip system integrating tissue sample preparation and multiplex RT-qPCR for gene expression analysis in point-of-care hepatotoxicity assessment. , 2015, Lab on a chip.

[101]  M. Sailor,et al.  Synthesis and characterization of a stable, label-free optical biosensor from TiO2-coated porous silicon. , 2014, Biosensors & bioelectronics.

[102]  T. Rang,et al.  Modelling and experimental characterisation of thermoelectric heating for molecular diagnostics devices , 2016, 2016 15th Biennial Baltic Electronics Conference (BEC).

[103]  Navid Rabiee,et al.  Point-of-care microfluidic devices for pathogen detection. , 2018, Biosensors & bioelectronics.