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Novel Point-of-Care Technologies in Diagnostics

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A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Point-of-Care Diagnostics and Devices".

Deadline for manuscript submissions: closed (31 May 2017) | Viewed by 115895

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Dr. Paul K. Drain

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Departments of Global Health, Medicine (Infectious Diseases), and Epidemiology, University of Washington, 325 Ninth Ave, UW Box 359927, Seattle, WA 98104, USA
Interests: HIV/AIDS; tuberculosis; point-of-care diagnostics; point-of-care testing; implementation science; global health; resource-limited settings
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Dear Colleagues,

Point-of-care tests have changed the delivery and impact of medical care by facilitating a migration of diagnostic testing from centralized laboratories to the clinical site of patient care, or even a person’s home. Research and development of point-of-care tests has grown steadily over the last 20 years, and the global point-of-care diagnostic market is expected to surpass US $30 billion in the year 2020. Point-of-care tests have been developed for use in all medical settings, a wide variety of medical specialties and subspecialties, and for both infectious and non-communicable diseases. Novel point-of-care technologies are becoming increasing more sophisticated and complex with lab-on-a-chip capabilities, and the latest generation of point-of-care tests offer rapid analysis of human and pathogen genomic data to accelerate more appropriate and personalized therapies.

Any successful point-of-care technology will require a balancing of accuracy, rapidity, accessibility, and cost. While a fundamental objective is to be diagnostically accurate, point-of-care tests that can be quickly and easily performed by clinical health care workers and at low operational costs will be the most successful. The largest potential impact will be in resource-limited settings, where expensive laboratory infrastructure is either inaccessible or completely unavailable. However, several studies of point-of-care tests have demonstrated only minimal impact on the burden of disease in resource-limited settings, suggesting their incorporation in health systems has either been incomplete or poorly implemented.

Although centralized reference laboratories will maintain a critical role in providing confirmatory diagnosis, future healthcare delivery is likely to be more reliant on point-of-care technologies. In this Special Issue of Diagnostics, we welcome submission of articles that showcase novel point-of-care technologies in diagnostics. An article may demonstrate sophisticated laboratory technologies that are pushing technological boundaries, clinical implementation solutions that balance the complexity and accessibility of novel technologies, or modeling studies that provide information on future strategies to safely use point-of-care technologies for maximal benefit. The success of point-of-care technologies will depend on demonstrating diagnostic accuracy and clinical value for the benefit of individuals and the health of communities.

Dr. Paul Drain
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

point-of-care test
diagnostic testing
screening
microfluidics
nucleic acid amplification
lab-on-a-chip
resource-limited settings

Related Special Issue

Novel Point-of-Care Technologies in Diagnostics 2018 in Diagnostics (6 articles)

Published Papers (10 papers)

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Research

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1824 KiB

Open AccessArticle

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

by Tivani P. Mashamba-Thompson, Ngcwalisa A. Jama, Benn Sartorius, Paul K. Drain and Rowan M. Thompson

Diagnostics 2017, 7(1), 3; https://doi.org/10.3390/diagnostics7010003 - 08 Jan 2017

Cited by 26 | Viewed by 9082

Abstract

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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Review

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Open AccessReview

Improving the Accessibility and Efficiency of Point-of-Care Diagnostics Services in Low- and Middle-Income Countries: Lean and Agile Supply Chain Management

by Desmond Kuupiel, Vitalis Bawontuo and Tivani P. Mashamba-Thompson

Diagnostics 2017, 7(4), 58; https://doi.org/10.3390/diagnostics7040058 - 29 Nov 2017

Cited by 48 | Viewed by 12229

Abstract

Access to point-of-care (POC) diagnostics services is essential for ensuring rapid disease diagnosis, management, control, and surveillance. POC testing services can improve access to healthcare especially where healthcare infrastructure is weak and access to quality and timely medical care is a challenge. Improving the accessibility and efficiency of POC diagnostics services, particularly in resource-limited settings, may be a promising route to improving healthcare outcomes. In this review, the accessibility of POC testing is defined as the distance/proximity to the nearest healthcare facility for POC diagnostics service. This review provides an overview of the impact of POC diagnostics on healthcare outcomes in low- and middle-income countries (LMICs) and factors contributing to the accessibility of POC testing services in LMICs, focusing on characteristics of the supply chain management and quality systems management, characteristics of the geographical location, health infrastructure, and an enabling policy framework for POC diagnostics services. Barriers and challenges related to the accessibility of POC diagnostics in LMICs were also discussed. Bearing in mind the reported barriers and challenges as well as the disease epidemiology in LMICs, we propose a lean and agile supply chain management framework for improving the accessibility and efficiency of POC diagnostics services in these settings. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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971 KiB

Open AccessReview

Development of Multiplexed Infectious Disease Lateral Flow Assays: Challenges and Opportunities

by Khayriyyah Mohd Hanafiah, Norsyahida Arifin, Yazmin Bustami, Rahmah Noordin, Mary Garcia and David Anderson

Diagnostics 2017, 7(3), 51; https://doi.org/10.3390/diagnostics7030051 - 07 Sep 2017

Cited by 45 | Viewed by 11175

Abstract

Lateral flow assays (LFAs) are the mainstay of rapid point-of-care diagnostics, with the potential to enable early case management and transform the epidemiology of infectious disease. However, most LFAs only detect single biomarkers. Recognizing the complex nature of human disease, overlapping symptoms and states of co-infections, there is increasing demand for multiplexed systems that can detect multiple biomarkers simultaneously. Due to innate limitations in the design of traditional membrane-based LFAs, multiplexing is arguably limited to a small number of biomarkers. Here, we summarize the need for multiplexed LFA, key technical and operational challenges for multiplexing, inherent in the design and production of multiplexed LFAs, as well as emerging enabling technologies that may be able to address these challenges. We further identify important areas for research in efforts towards developing multiplexed LFAs for more impactful diagnosis of infectious diseases. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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199 KiB

Open AccessReview

New Biomarkers and Diagnostic Tools for the Management of Fever in Low- and Middle-Income Countries: An Overview of the Challenges

by Camille Escadafal, Christian Nsanzabana, Julie Archer, Violet Chihota, William Rodriguez and Sabine Dittrich

Diagnostics 2017, 7(3), 44; https://doi.org/10.3390/diagnostics7030044 - 21 Jul 2017

Cited by 16 | Viewed by 8684

Abstract

A lack of simple, inexpensive, and rapid diagnostic tests for febrile illnesses other than malaria leads to overtreatment with antibiotics for those who test negative for malaria, and contributes to the global rise in antimicrobial resistance. New tests for the detection of host biomarkers provide promising tools to differentiate bacterial from non-bacterial infections in febrile patients. However, most available biomarker tests are not currently used in resource-limited settings, and very few evaluations have been performed in low- and middle-income country populations with non-severe febrile illness. As a result, our knowledge of the performance of these tests in settings with high prevalence of infectious and poverty-related diseases such as malaria, HIV, malnutrition and intestinal parasites is poor. This paper describes challenges faced during the process of getting to an approved test, including difficulties in selecting the most appropriate fever biomarkers; suitable study designs and sites for test evaluations; lack of available reference tests to evaluate the performance of new tests; and lack of clear regulatory pathways to introduce such tests. As many new biomarker assays are in development, understanding these challenges will better enable those working in this area to address them during product development. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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843 KiB

Open AccessReview

Advancing Point-of-Care (PoC) Testing Using Human Saliva as Liquid Biopsy

by Rabia Sannam Khan, Zohaib Khurshid and Faris Yahya Ibrahim Asiri

Diagnostics 2017, 7(3), 39; https://doi.org/10.3390/diagnostics7030039 - 04 Jul 2017

Cited by 86 | Viewed by 14432

Abstract

Salivary diagnostics is an emerging field for the encroachment of point of care technology (PoCT). The necessity of the development of point-of-care (PoC) technology, the potential of saliva, identification and validation of biomarkers through salivary diagnostic toolboxes, and a broad overview of emerging technologies is discussed in this review. Furthermore, novel advanced techniques incorporated in devices for the early detection and diagnosis of several oral and systemic diseases in a non-invasive, easily-monitored, less time consuming, and in a personalised way is explicated. The latest technology detection systems and clinical utilities of saliva as a liquid biopsy, electric field-induced release and measurement (EFIRM), biosensors, smartphone technology, microfluidics, paper-based technology, and how their futuristic perspectives can improve salivary diagnostics and reduce hospital stays by replacing it with chairside screening is also highlighted. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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2919 KiB

Open AccessReview

Analytical Tools to Improve Optimization Procedures for Lateral Flow Assays

by Helen V. Hsieh, Jeffrey L. Dantzler and Bernhard H. Weigl

Diagnostics 2017, 7(2), 29; https://doi.org/10.3390/diagnostics7020029 - 28 May 2017

Cited by 79 | Viewed by 15324

Abstract

Immunochromatographic or lateral flow assays (LFAs) are inexpensive, easy to use, point-of-care medical diagnostic tests that are found in arenas ranging from a doctor’s office in Manhattan to a rural medical clinic in low resource settings. The simplicity in the LFA itself belies the complex task of optimization required to make the test sensitive, rapid and easy to use. Currently, the manufacturers develop LFAs by empirical optimization of material components (e.g., analytical membranes, conjugate pads and sample pads), biological reagents (e.g., antibodies, blocking reagents and buffers) and the design of delivery geometry. In this paper, we will review conventional optimization and then focus on the latter and outline analytical tools, such as dynamic light scattering and optical biosensors, as well as methods, such as microfluidic flow design and mechanistic models. We are applying these tools to find non-obvious optima of lateral flow assays for improved sensitivity, specificity and manufacturing robustness. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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187 KiB

Open AccessReview

Exploring the Case for a Global Alliance for Medical Diagnostics Initiative

by Melissa L. Mugambi, Kara M. Palamountain, Jim Gallarda and Paul K. Drain

Diagnostics 2017, 7(1), 8; https://doi.org/10.3390/diagnostics7010008 - 26 Jan 2017

Cited by 12 | Viewed by 8652

Abstract

In recent years, the private and public sectors have increased investments in medical diagnostics for low- and middle-income countries (LMICs). Despite these investments, numerous barriers prevent the adoption of existing diagnostics and discourage the development and introduction of new diagnostics in LMICs. In the late 1990s, the global vaccine community had similar challenges, as vaccine coverage rates stagnated and the introduction of new vaccines was viewed as a distraction to delivering existing vaccines. To address these challenges, the international community came together and formed the Global Alliance for Vaccines Initiative (GAVI). Sixteen years after the formation of GAVI, we see evidence of a healthier global vaccine landscape. We discuss how GAVI’s four guiding principles (product, health systems strengthening, financing and market shaping) might apply to the advancement of medical diagnostics in LMICs. We present arguments for the international community and existing organizations to establish a Global Alliance for Medical Diagnostics Initiative (GAMDI). Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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5789 KiB

Open AccessReview

Gold Nanoparticles for Diagnostics: Advances towards Points of Care

by Mílton Cordeiro, Fábio Ferreira Carlos, Pedro Pedrosa, António Lopez and Pedro Viana Baptista

Diagnostics 2016, 6(4), 43; https://doi.org/10.3390/diagnostics6040043 - 22 Nov 2016

Cited by 95 | Viewed by 17738

Abstract

The remarkable physicochemical properties of gold nanoparticles (AuNPs) have prompted developments in the exploration of biomolecular interactions with AuNP-containing systems, in particular for biomedical applications in diagnostics. These systems show great promise in improving sensitivity, ease of operation and portability. Despite this endeavor, most platforms have yet to reach maturity and make their way into clinics or points of care (POC). Here, we present an overview of emerging and available molecular diagnostics using AuNPs for biomedical sensing that are currently being translated to the clinical setting. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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1539 KiB

Open AccessReview

Point-of-Care Diagnostics for Improving Maternal Health in South Africa

by Tivani P. Mashamba-Thompson, Benn Sartorius and Paul K. Drain

Diagnostics 2016, 6(3), 31; https://doi.org/10.3390/diagnostics6030031 - 31 Aug 2016

Cited by 6 | Viewed by 9081

Abstract

Improving maternal health is a global priority, particularly in high HIV-endemic, resource-limited settings. Failure to use health care facilities due to poor access is one of the main causes of maternal deaths in South Africa. “Point-of-care” (POC) diagnostics are an innovative healthcare approach to improve healthcare access and health outcomes in remote and resource-limited settings. In this review, POC testing is defined as a diagnostic test that is carried out near patients and leads to rapid clinical decisions. We review the current and emerging POC diagnostics for maternal health, with a specific focus on the World Health Organization (WHO) quality-ASSURED (Affordability, Sensitivity, Specificity, User friendly, Rapid and robust, Equipment free and Delivered) criteria for an ideal point-of-care test in resource-limited settings. The performance of POC diagnostics, barriers and challenges related to implementing POC diagnostics for maternal health in rural and resource-limited settings are reviewed. Innovative strategies for overcoming these barriers are recommended to achieve substantial progress on improving maternal health outcomes in these settings. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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Other

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Open AccessCommentary

Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations

by Megan Smallwood and Nitika Pant Pai

Diagnostics 2017, 7(1), 13; https://doi.org/10.3390/diagnostics7010013 - 04 Mar 2017

Cited by 3 | Viewed by 6931

Abstract

The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic. Acutely infected individuals are thought to contribute substantially to forward transmissions of HIV; however, diagnosing AHI in resource-limited settings has proven to be a challenge. While fourth generation antigen-antibody combination assays have been successful in high-resource settings, rapid point of care (POC) versions of these assays have yet to demonstrate high sensitivity to detect AHI. Newer RNA/DNA based POC technologies are being validated, but the challenge to understand the additional value of these devices depends on the quality of study evaluations, in particular choice of study designs and case mix of included populations. In this commentary, we aimed to review the quality of studies evaluating a new fourth generation rapid test for detecting AHI, to identify general methodological limitations and biases in diagnostic accuracy studies, and to recommend strategies for avoiding them in future evaluations. The new studies that were evaluated continued to report the same weaknesses and biases that were seen in previous evaluations of fourth generation rapid tests. We recommend that investigators design future studies carefully, keeping in mind how diagnostic performance may be influenced by prevalence, population, patient case mixes, and reference standards. Care must be taken to avoid biases specific to diagnostic accuracy studies (spectrum, verification, incorporation and reference standard biases). To improve on quality, reporting checklists and guidelines such as Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Standards for Reporting Diagnostic accuracy studies (STARD) should be reviewed prior to conducting studies. Full article

(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)

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