Point-of-Care Diagnostics

The market is increasing for point-of-care testing with the growth of boundary-less hospitals and community care and the need for rapid results outside of the clinical setting. Point-of-care testing serves a pivotal function for delivering precision medicine that will both improve quality and affordability of care at a time when outcomes-based medicine is the new model for healthcare. This conference will examine the growing need for point-of-care tests to manage disease outbreaks and offer rapid diagnosis for a host of applications and also address technology development and implementation barriers.

Final Agenda


12:30 Registration


13:30 Chairperson’s Opening Remarks

Wilfried von Eiff, Ph.D., Academic Director, Center for Health Care Management and Regulation, HHL, Leipzig Graduate School of Management, Germany

13:35 Point-of-Impact Testing in the Emergency Department: Rapid Diagnostics for Respiratory Viral Infections

Hubert_NiestersH.G.M. Niesters, Ph.D., Director, Laboratory of Clinical Virology, University Medical Center Groningen, The Netherlands

The ability to determine rapidly respiratory viruses for patients visiting the emergency room, has shown that the cost/benefit ratio is favorable for both the patient (better care) as well as for the hospital (reduced cost) and on infection control measurements. These advantages of point-of-impact testing also clearly show that the current pressure to reduce costs for diagnostics is completely unfavorable for the only client we have, i.e. the patient.

14:05 The Boundaryless Hospital Approach: Background, Aims and Elements

Wilfried_von_EiffWilfried von Eiff, Ph.D., Professor, International Health Care and Hospital Management; Academic Director, Center for Health Care Management and Regulation, HHL, Leipzig Graduate School of Management; Director, Center for Hospital Management at University of Muenster, Germany

Luís Velez Lapão, Habil., Ph.D., MSc, Professor, International Public Health, Population Health, Policies and Services Group Leader, Global Health and Tropical Medicine, Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa, Portugal

In this presentation the nature, aims and impacts of the “Boundaryless Hospital Management Approach” on the quality of medical services along the “continuum of care” are described. In addition, selected network concepts like the portal clinic approach, cross-sectoral contracting, managed care opportunities and emergency network design are depicted. Furthermore, process improvement opportunities by implementing POCT technology in an emergency department are reflected. To conclude, the role of Digital Transformation in Improving Boundaryless Hospital Management will be addressed.

14:35 KEYNOTE PRESENTATION: Novel Analytical Opportunities for Patient-Near Testing

Peter LuppaPeter B. Luppa, Ph.D., Head, Central Laboratory, Institute for Clinical Chemistry, Technische Universität München, Germany

The presentation generally defines the application fields of POCT and portrays the different instrument categories and analytical principles. In the focus are the analytical challenges of future POCT diagnostics. A series of novel POCT devices, broadening the spectrum of POCT analytics, will be presented. Among them, molecular-biological methods for nucleic acid detection of infectious agents will be addressed. Innovative nanoparticle-based techniques and alternative biological recognition elements will be elucidated in detail.

15:15 Refreshment Break in the Exhibit Hall with Poster Viewing

Enabling Technologies for Point-of-Care Diagnostics

16:15 Chairperson’s Remarks: Introduction to Status and Trends in Cartridge-Based POCD

Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH, Germany

16:30 Building Your Future Diagnostic Product with IMEC’s Smart Silicon Chip Solutions

Liesbet_LagaeLiesbet Lagae, Ph.D., Program Director, Life Science Technologies, IMEC, Belgium

Multitarget biosensors hold great promise to improve point-of-care diagnostics as they enable simultaneous detection of different biomolecular markers. Multiplexed detection of different markers, like cells, genes, proteins, or a combination of both, propels advancement in numerous fields such as genomics, medical diagnosis and therapy monitoring. IMEC has developed the most powerful silicon platform for multiplexed and multitarget detection. We will give examples of projects in development with industrial partners.

17:00 Precision Diagnostics Based on Modular Capillary-Driven Elements and with Smartphone Connectivity

Emmanuel_DelamarcheEmmanuel Delamarche, Ph.D., Manager, Precision Diagnostics, IBM Research, Switzerland

I will present how to program capillary flow and encode specific functions to form microfluidic elements that can easily be assembled into self-powered devices for immunoassays. Small peripherals can augment the functionality of microfluidic chips having electrodes for monitoring flow with sub-nanoliter precision and providing connectivity to smartphones. All together, these concepts may extend the performances of microfluidic devices for point-of-care diagnostics to a next level of precision.

17:30 Rapid Diagnostic Tests to Tackle Antimicrobial Resistance

Till T. Bachmann, Ph.D., Reader, Personalised Medicine in Infectious Disease; Deputy Head, Division of Infection and Pathway Medicine, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom

Antimicrobial Resistance (AMR) has become a global threat and rapid diagnostics are urgently needed to tackle this challenge. Depending on the clinical scenario and use case, these rapid tests should be suitable for point-of-care testing and detect the right targets and biomarkers to provide information with high clinical utility fulfilling a desired target product profile. The presentation will cover our own research on multiparametric detection using point-of-care sensors in the context of global developments and strategic activities for development and implementation of rapid diagnostic tests to fight AMR.

18:00 Close of Day


Commercialization of POCT

08:30 Registration and Morning Coffee

09:00 Chairperson’s Remarks

John C. Carrano, Ph.D., President & CEO, Paratus Diagnostics LLC, United States

09:05 Convergence of Microfluidics and Consumer Electronics towards Field-Deployable Point-of-Care Tests

Samuel_SiaSamuel K. Sia, Ph.D., Professor, Biomedical Engineering, Columbia University; Founder, Claros, United States

Lab-on-a-chip (LOC) devices have a tremendous potential for revolutionizing personal health. In the U.S., patients and consumers can have greater access to traditionally complex diagnostics, and in developing countries, mobile diagnostics provides immediate diagnosis in the field. We will discuss our lab’s current efforts in these areas, in conjunction with partners in industry, public health, and local governments. Our tests span a variety of technologies, and target HIV, sexually transmitted diseases, and chronic diseases.

09:35 Digital Microfluidics: Sample Preparation to Detection

Irena_Barbulovic-NadIrena Barbulovic-Nad, Ph.D., Co-Founder, Kapplex, Canada

Microfluidic techniques provide means to miniaturize biochemical assays and to package clinical diagnostics into disposable, point-of-care test cartridges. However, there are only a few technologies that can miniaturize and integrate a complete assay – from sample preparation to multiplexed biomarker detection – at a low cost. Digital microfluidics is a leading lab-on-a-chip technology enabling integration of series of complex sample purification and preparation steps, into a simple, cost-effective, diagnostic device.

10:05 Striking a Balance: Developing Multiplexed POC Assays for Military and Civilian Use

Christian J. Whitchurch, Ph.D., Chief Scientist, Detection & Diagnostics, Defense Threat Reduction Agency, United States

The common need for robust point-of-care (POC) medical diagnostics in both the civilian and military realms can obscure the distinct challenges inherent in designing assays suitable for either use. Military requirements for rugged, portable platforms and the capability to identify biological or chemical weapons exposure may limit the commercial opportunities that are critical to developing successful clinical diagnostic devices. This talk will outline the attributes of DTRA’s approach to develop multiplexed POC diagnostics that strike this balance between military and civilian utility.

10:35 Coffee Break in the Exhibit Hall with Poster Viewing

11:15 Microfluidic Diagnostics without Sample Preparation: A New Reality?

Ana_Ferreira_BarbosaAna Isabel Ferreira-Barbosa, Ph.D., IVD Manufacture Scientist, Capillary Film Technology Ltd., United Kingdom

A big challenge in the performance of portable point-of-care (POC) diagnostic devices is the interference of biological sample components with the test results, something often called “matrix effect”. Sample preparation increases complexity and cost of miniaturized POC tests, being a bottleneck in the development of affordable POC tests. Our research team has reported for the first time (to our knowledge) portable testing of protein biomarkers from whole blood and undiluted serum in a novel miniaturized platform, with performance matching that with buffer. This presentation will explain how assay miniaturization offers an opportunity to avoid complex sample preparation procedures.

11:45 Panel Discussion: Commercializing a POCT Product

12:20 Sponsored Presentation (Opportunity Available)

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:20 Session Break


14:15 Chairperson’s Remarks

Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, United States

14:20 Rapid Molecular Diagnostic Testing: A Major Weapon in Fighting Viruses and Antimicrobial Resistance

Gyorgy_AbelGyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, United States

Rapid point-of-care molecular infectious disease testing holds great promise in the fight against viral and bacterial infections and antimicrobial resistance. This presentation reviews state-of-art rapid technologies for respiratory pathogen and positive blood culture testing, and discusses the concerted multi-disciplinary effort required to make test results readily available and actionable to health care providers. Hurdles to broader use include cost, quality issues, regulation, and complexity of integration of the results into patient care.

14:50 Practical Implementation of POCT: Overcoming Challenges

James_NicholsJames H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine, United States

POCT is an increasingly popular means of delivering laboratory testing with faster turnaround of results. However, the apparent simplicity of the devices diminishes the underlying risk of errors and numerous ways that operators can perform the testing. This session will focus on the challenges of implementing and maintaining POCT and will provide tips for ensuring quality, reliable test results.

15:20 Do Regulations and Guidelines for POCT Guarantee Qualitative and Safe Diagnostic Testing?

Viviane Van Hoof, M.D., Ph.D., Vice-Head, Clinical Biology, Antwerp University Hospital, Belgium

Specific guidelines and regulations for point-of-care testing (POCT) should guarantee a qualitative and safe diagnostic care. An overview and a critical appraisal will be given of the POCT regulations and guidelines issued by FDA/CLIA, CLSI, JCI, CAP, EU and ISO22870. The Dutch guidelines and the Belgian legislation on POCT will be discussed. Serious consequences of loopholes in the current POCT regulation will be illustrated by means of recent events.

15:50 New POCT Technologies and Platforms

Günther_ProllGünther Proll, Ph.D., Institute of Physical and Theoretical Chemistry, Eberhard Karls University Tübingen, Germany

The development of new POCT technologies and platforms has to take into account the complete analytical procedure from sampling to validated data generation in a regulated environment. Within this talk, results of several current research projects will highlight novel parameters in POCT, new analytical strategies as combinations of test format and transduction including use of nanotechnology, and cost effective production processes.

16:25 Refreshment Break


16:40 Chairperson’s Remarks

James H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine, United States

16:45 Feasibility for Implementation of an ‘On-Line’ Clinical Investigative Ambulance

Ashfaq_GilkarAshfaq Gilkar, Senior Clinical Analyst, Strategy and Engagement, Essentia Technology, Guy’s and St Thomas’ NHS Foundation Trust, United Kingdom

The aim of this proposal is to ascertain whether interfacing on-line POCT devices (Abbott ISTAT and Radiometer HaemaCue blood analysers) within an ‘Ambulance’ setting prior to entry to the hospital could help front line staff accelerate decision making, reduce congestion and most importantly, improve patient waiting times in a busy A&E department or contribute to increasing see, treat and discharge in the community thus reducing the burden on the hospital A&E department. This life saving project will directly address the major national problem of congestion in the A&E department for Ambulance derived patients and help reduce admissions into the acute hospital, improving Clinical outcomes while at the same time the need to improve the level of clinical data integrity.

17:15 A Bio-Nano Approach to Point-of-Care Testing of Parasitic DNA in Resource Limited Settings

Michel Bengtson, Bionanoscience, Delft University of Technology

17:45 Close of Conference