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Lancet Infect Dis ; 20(9): e245-e249, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32687805

RESUMEN

The collapse of global cooperation and a failure of international solidarity have led to many low-income and middle-income countries being denied access to molecular diagnostics in the COVID-19 pandemic response. Yet the scarcity of knowledge on the dynamics of the immune response to infection has led to hesitation on recommending the use of rapid immunodiagnostic tests, even though rapid serology tests are commercially available and scalable. On the basis of our knowledge and understanding of viral infectivity and host response, we urge countries without the capacity to do molecular testing at scale to research the use of serology tests to triage symptomatic patients in community settings, to test contacts of confirmed cases, and in situational analysis and surveillance. The WHO R&D Blue Print expert group identified eight priorities for research and development, of which the highest is to mobilise research on rapid point-of-care diagnostics for use at the community level. This research should inform control programmes of the required performance and utility of rapid serology tests, which, when applied specifically for appropriate public health measures to then be put in place, can make a huge difference.


Asunto(s)
Anticuerpos Antivirales/metabolismo , Betacoronavirus/aislamiento & purificación , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Anticuerpos Antivirales/sangre , Betacoronavirus/genética , Betacoronavirus/inmunología , Trazado de Contacto/métodos , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/transmisión , Humanos , Inmunoglobulina G/sangre , Inmunoglobulina G/metabolismo , Inmunoglobulina M/sangre , Inmunoglobulina M/metabolismo , Pandemias/prevención & control , Neumonía Viral/inmunología , Neumonía Viral/prevención & control , Neumonía Viral/transmisión , ARN Viral/análisis , Factores de Tiempo , Triaje/métodos , Esparcimiento de Virus
4.
Lancet Infect Dis ; 20(10): e268-e273, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32717208

RESUMEN

Outbreaks of infectious diseases are occurring with increasing frequency and unpredictability. The rapid development and deployment of diagnostics that can accurately and quickly identify pathogens as part of epidemic preparedness is needed now for the COVID-19 pandemic. WHO has developed a global research and innovation forum to facilitate, accelerate, and deepen research collaboration among countries and funders. Great progress has been made in the past decade, but access to specimens remains a major barrier for the development and evaluation of needed quality diagnostics. We present a sustainable model for a global network of country-owned biobanks with standardised methods for collection, characterisation, and archiving of specimens and pathogens to facilitate and accelerate diagnostics development and evaluation for COVID-19 and other diseases of epidemic potential. The biobanking network should be run on the guiding principles of transparency, equitable access, ethics, and respect for national laws that support country ownership and sustainability. Adapting the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits, sharing of specimens from national biobanks can be rewarded through mechanisms such as equitable access to diagnostics at negotiated prices. Such networks should be prepared for any pathogen of epidemic potential.


Asunto(s)
Bancos de Muestras Biológicas/organización & administración , Bancos de Muestras Biológicas/normas , Enfermedades Transmisibles/diagnóstico , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Betacoronavirus/aislamiento & purificación , Control de Enfermedades Transmisibles , Enfermedades Transmisibles/epidemiología , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Pruebas Diagnósticas de Rutina , Epidemias/prevención & control , Humanos , Cooperación Internacional , Pandemias/prevención & control , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Manejo de Especímenes/normas , Desarrollo Sostenible
6.
Sex Transm Infect ; 96(5): 342-347, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32241905

RESUMEN

OBJECTIVES: In 2016, WHO estimated 376 million new cases of the four main curable STIs: gonorrhoea, chlamydia, trichomoniasis and syphilis. Further, an estimated 290 million women are infected with human papillomavirus. STIs may lead to severe reproductive health sequelae. Low-income and middle-income countries carry the highest global burden of STIs. A large proportion of urogenital and the vast majority of extragenital non-viral STI cases are asymptomatic. Screening key populations and early and accurate diagnosis are important to provide correct treatment and to control the spread of STIs. This article paints a picture of the state of technology of STI point-of-care testing (POCT) and its implications for health system integration. METHODS: The material for the STI POCT landscape was gathered from publicly available information, published and unpublished reports and prospectuses, and interviews with developers and manufacturers. RESULTS: The development of STI POCT is moving rapidly, and there are much more tests in the pipeline than in 2014, when the first STI POCT landscape analysis was published on the website of WHO. Several of the available tests need to be evaluated independently both in the laboratory and, of particular importance, in different points of care. CONCLUSION: This article reiterates the importance of accurate, rapid and affordable POCT to reach universal health coverage. While highlighting the rapid technical advances in this area, we argue that insufficient attention is being paid to health systems capacity and conditions to ensure the swift and rapid integration of current and future STI POCT. Unless the complexity of health systems, including context, institutions, adoption systems and problem perception, are recognised and mapped, simplistic approaches to policy design and programme implementation will result in poor realisation of intended outcomes and impact.


Asunto(s)
Prestación de Atención de Salud/organización & administración , Pruebas en el Punto de Atención/organización & administración , Enfermedades de Transmisión Sexual/diagnóstico , Infecciones por Chlamydia/diagnóstico , Infecciones por Chlamydia/tratamiento farmacológico , Infecciones por Chlamydia/prevención & control , Infecciones por Chlamydia/transmisión , Femenino , Gonorrea/diagnóstico , Gonorrea/tratamiento farmacológico , Gonorrea/prevención & control , Gonorrea/transmisión , Infecciones por VIH/diagnóstico , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Humanos , Ciencia de la Implementación , Masculino , Infecciones por Mycoplasma/diagnóstico , Infecciones por Mycoplasma/tratamiento farmacológico , Infecciones por Mycoplasma/prevención & control , Infecciones por Mycoplasma/transmisión , Mycoplasma genitalium , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/prevención & control , Infecciones por Papillomavirus/transmisión , Enfermedades de Transmisión Sexual/tratamiento farmacológico , Enfermedades de Transmisión Sexual/prevención & control , Enfermedades de Transmisión Sexual/transmisión , Sífilis/diagnóstico , Sífilis/tratamiento farmacológico , Sífilis/prevención & control , Sífilis/transmisión , Vaginitis por Trichomonas/diagnóstico , Vaginitis por Trichomonas/tratamiento farmacológico , Vaginitis por Trichomonas/prevención & control , Vaginitis por Trichomonas/transmisión
7.
Infect Dis Poverty ; 9(1): 20, 2020 Feb 19.
Artículo en Inglés | MEDLINE | ID: mdl-32070433

RESUMEN

BACKGROUND: Diagnostics are essential for identifying and controlling diseases. However, limited access to diagnostics hinders public health efforts in many settings. Social innovation may provide a framework for expanding access to diagnostics in the global south. Here social innovation is defined as implementing a known public health tool via a novel, community-driven technique. MAIN BODY: In this article, we discuss three diverse cases that show the potential for using social innovation in diagnostics. The cases chosen for inclusion here demonstrate the importance of social innovation in diagnostics across different geographic, cultural, and health system contexts. They include malaria testing via schools in Malawi, cervical human papillomavirus (HPV) sample self-collection in Peru, and crowdsourcing human immunodeficiency virus (HIV) testing in China. For each case, we present the public health problem and the impact of using social innovation to increase accessibility of diagnostics. We discuss implications of each diagnostic approach and the importance of social innovation in creating these potential solutions. We argue that social innovation is useful in improving the delivery of essential diagnostic tools in low- and middle-income countries. CONCLUSIONS: Interventions in Malawi, Peru, and China suggest social innovation increases uptake of diagnostics. The same tools and principles utilized in these cases can be adapted for use in other contexts. Such diagnostic innovations may help improve identification of and linkage to care for many diseases. The approach presents a unique opportunity to better address public health issues and increase accessibility in LMIC health systems.


Asunto(s)
Servicios de Diagnóstico , Innovación Organizacional , Salud Pública , Humanos
8.
Infect Dis Poverty ; 8(1): 81, 2019 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-31514738

RESUMEN

BACKGROUND: Despite great medical advances and scientific progress over the past century, one billion people globally still lack access to basic health care services. In the context of the 2030 Agenda for Sustainable Development social innovation models aim to provide effective solutions that bridge the health care delivery gap, address equity and create social value. This commentary highlights the roles of multilateral organizations and governments in creating an enabling environment where social innovations can more effectively integrate into health systems to maximize their impact on beneficiaries. MAIN TEXT: The integration of social innovations into health systems is essential to ensure their sustainability and the wide dissemination of their impact. Effective partnerships, strong engagement with and endorsement by governments and communities, regulations, trust and sometimes willingness are key factors to enhance system integration, replication and dissemination of the models. Three examples of social innovations selected by the Social Innovation in Health Initiative illustrate the importance of engaging with governments and communities in order to link, integrate and synergize their efforts. Key challenges that they encountered, and lessons learnt are highlighted. Multilateral organizations and governments increasingly engage in promoting and supporting the development, testing and dissemination of social innovations to address the health care delivery gap. They play an important role in creating an enabling environment. This includes promoting the concept of social innovation in health care delivery, spreading social innovation approach and lessons learnt, fostering partnerships and leveraging resources, convening communities, health system actors and various stakeholders to work together across disciplines and sectors, and nurturing capacity in countries. CONCLUSIONS: Multilateral organizations and local and national governments have a critical role to play in creating an enabling environment where social innovations can flourish. In supporting and disseminating social innovation approach, multilateral organizations and governments have a great opportunity to accelerate Universal Health Coverage and the achievement of the Sustainable Development Goals.


Asunto(s)
Prestación de Atención de Salud/métodos , Difusión de Innovaciones , Gobierno , Agencias Internacionales/estadística & datos numéricos , Prestación de Atención de Salud/legislación & jurisprudencia , Prestación de Atención de Salud/estadística & datos numéricos , Humanos
10.
Nature ; 566(7745): 467-474, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30814711

RESUMEN

Mobile health, or 'mHealth', is the application of mobile devices, their components and related technologies to healthcare. It is already improving patients' access to treatment and advice. Now, in combination with internet-connected diagnostic devices, it offers novel ways to diagnose, track and control infectious diseases and to improve the efficiency of the health system. Here we examine the promise of these technologies and discuss the challenges in realizing their potential to increase patients' access to testing, aid in their treatment and improve the capability of public health authorities to monitor outbreaks, implement response strategies and assess the impact of interventions across the world.


Asunto(s)
Enfermedades Transmisibles/diagnóstico , Enfermedades Transmisibles/terapia , Telemedicina/métodos , Telemedicina/organización & administración , Control de Enfermedades Transmisibles/métodos , Control de Enfermedades Transmisibles/organización & administración , Enfermedades Transmisibles/epidemiología , Enfermedades Transmisibles/transmisión , Trazado de Contacto , Análisis de Datos , Brotes de Enfermedades/prevención & control , Brotes de Enfermedades/estadística & datos numéricos , Humanos , Sistemas de Atención de Punto , Salud Pública/métodos , Salud Pública/tendencias , Teléfono Inteligente , Telemedicina/tendencias
11.
BMJ Glob Health ; 4(Suppl 2): e001179, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30815287

RESUMEN

Diagnostics are fundamental for successful outbreak containment. In this supplement, 'Diagnostic preparedness for WHO Blueprint pathogens', we describe specific diagnostic challenges presented by selected priority pathogens most likely to cause future epidemics. Some challenges to diagnostic preparedness are common to all outbreak situations, as highlighted by recent outbreaks of Ebola, Zika and yellow fever. In this article, we review these overarching challenges and explore potential solutions. Challenges include fragmented and unreliable funding pathways, limited access to specimens and reagents, inadequate diagnostic testing capacity at both national and community levels of healthcare and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods. Addressing these challenges in an efficient and effective way will require multiple stakeholders-public and private-coordinated in implementing a holistic approach to diagnostics preparedness. All require strengthening of healthcare system diagnostic capacity (including surveillance and education of healthcare workers), establishment of sustainable financing and market strategies and integration of diagnostics with existing mechanisms. Identifying overlaps in diagnostic development needs across different priority pathogens would allow more timely and cost-effective use of resources than a pathogen by pathogen approach; target product profiles for diagnostics should be refined accordingly. We recommend the establishment of a global forum to bring together representatives from all key stakeholders required for the response to develop a coordinated implementation plan. In addition, we should explore if and how existing mechanisms to address challenges to the vaccines sector, such as Coalition for Epidemic Preparedness Innovations and Gavi, could be expanded to cover diagnostics.

12.
Nat Microbiol ; 4(1): 46-54, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30546093

RESUMEN

Lack of access to quality diagnostics remains a major contributor to health burden in resource-limited settings. It has been more than 10 years since ASSURED (affordable, sensitive, specific, user-friendly, rapid, equipment-free, delivered) was coined to describe the ideal test to meet the needs of the developing world. Since its initial publication, technological innovations have led to the development of diagnostics that address the ASSURED criteria, but challenges remain. From this perspective, we assess factors contributing to the success and failure of ASSURED diagnostics, lessons learnt in the implementation of ASSURED tests over the past decade, and highlight additional conditions that should be considered in addressing point-of-care needs. With rapid advances in digital technology and mobile health (m-health), future diagnostics should incorporate these elements to give us REASSURED diagnostic systems that can inform disease control strategies in real-time, strengthen the efficiency of health care systems and improve patient outcomes.


Asunto(s)
Control de Enfermedades Transmisibles/métodos , Infecciones por VIH/diagnóstico , Malaria/diagnóstico , Sistemas de Atención de Punto , Sífilis/diagnóstico , Tuberculosis Pulmonar/diagnóstico , Enfermedades Transmisibles/diagnóstico , Servicios de Diagnóstico , Humanos
13.
Lancet Infect Dis ; 19(5): e172-e178, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30551872

RESUMEN

Global epidemics of infectious diseases are increasing in frequency and severity. Diagnostics are needed for rapid identification of the cause of the epidemic to facilitate effective control and prevention. Lessons learned from the recent Ebola virus and Zika virus epidemics are that delay in developing the right diagnostic for the right population at the right time has been a costly barrier to disease control and prevention. We believe that it is possible to accelerate and optimise diagnostic development through a five-pronged strategy: by doing a global landscape analysis of diagnostic availability worldwide; through strategic partnerships for accelerating test development, in particular with vaccine companies to identify novel diagnostic targets; by creating and sharing repositories of data, reagents, and well characterised specimens for advancing the development process; by involving key public and private stakeholders, including appropriate regulatory bodies and policy makers, to ensure rapid access for researchers to diagnostics; and last, by fostering an enabling environment for research and access to diagnostics in the countries that need them. The need is great, but not insurmountable and innovative and faster development pathways are urgently required to address current shortfalls.


Asunto(s)
Pruebas Diagnósticas de Rutina , Epidemias/prevención & control , Fiebre Hemorrágica Ebola/diagnóstico , Infección por el Virus Zika/diagnóstico , Bioensayo , Bases de Datos Factuales/provisión & distribución , Ebolavirus/aislamiento & purificación , Monitoreo Epidemiológico , Fiebre Hemorrágica Ebola/epidemiología , Fiebre Hemorrágica Ebola/virología , Humanos , Difusión de la Información/métodos , Asociación entre el Sector Público-Privado/organización & administración , Virus Zika/aislamiento & purificación , Infección por el Virus Zika/epidemiología , Infección por el Virus Zika/virología
15.
Global Health ; 14(1): 102, 2018 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-30382856

RESUMEN

Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.


Asunto(s)
Países en Desarrollo , Medicamentos Esenciales/provisión & distribución , Salud Global/economía , Prioridades en Salud , Humanos , Legislación de Medicamentos
16.
APMIS ; 126(12): 907-912, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30456870

RESUMEN

Effective tests for diagnosis of sexually transmitted infections (STIs), used point of care to inform treatment and management decisions, are urgently needed. We evaluated the analytical sensitivity and specificity of the Xpert® CT/NG and Xpert® TV tests, examining 339 samples spiked with phenotypically and/or genetically diverse strains of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, and other related species that may cross-react. The APTIMA Combo 2 test and APTIMA TV test were used as reference tests. The analytical sensitivity for all three agents in the Xpert® CT/NG and Xpert® TV tests was ≤102 genome equivalents/reaction. The analytical specificity of both tests was high. False-positive results were identified in the Xpert® TV test when challenging with high concentrations of Trichomonas tenax, Trichomonas gallinae, Trichomonas stableri, and Trichomonas aotus. However, the clinical relevance of these cross-reactions can likely be neglected, because these species have not been identified in urogenital samples from humans. In conclusion, the analytical sensitivity and specificity of the user-friendly Xpert® CT/NG and Xpert® TV tests on the GeneXpert system were high. The results support the use of specimens from also extra-genital sites, for example, pharynx and rectum. However, appropriate clinical validations are additionally required.


Asunto(s)
Técnicas de Diagnóstico Molecular/métodos , Sistemas de Atención de Punto , Enfermedades de Transmisión Sexual/diagnóstico , Reacciones Cruzadas , Reacciones Falso Positivas , Femenino , Humanos , Masculino , Sensibilidad y Especificidad
17.
AIDS ; 32(15): 2089-2102, 2018 09 24.
Artículo en Inglés | MEDLINE | ID: mdl-30102659

RESUMEN

: Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. Although rapid antibody PoC and laboratory-based nucleic acid amplification tests dominate the diagnostics market, the viral capsid protein p24 is recognized as an alternative early virological biomarker of infection. However, the detection of ultra-low levels of p24 at the PoC has proven challenging. Here we review the landscape of p24 diagnostics to identify knowledge gaps and barriers and help shape future research agendas. Five hundred and seventy-four research articles to May 2018 that propose or evaluate diagnostic assays for p24 were identified and reviewed. We give a brief history of diagnostic development, and the utility of p24 as a biomarker in different populations such as infants, the newly infected, those on preexposure prophylaxis and self-testers. We review the performance of commercial p24 assays and consider elements such as immune complex disruption, resource-poor settings, prevalence, and assay antibodies. Emerging and ultrasensitive assays are reviewed and show a number of promising approaches but further translation has been limited. We summarize studies on the health economic benefits of using antigen testing. Finally, we speculate on the future uses of high-performance p24 assays, particularly, if available in self-test format.


Asunto(s)
Pruebas Diagnósticas de Rutina/métodos , Proteína p24 del Núcleo del VIH/sangre , Infecciones por VIH/diagnóstico , Pruebas en el Punto de Atención , Diagnóstico Precoz , Humanos
18.
Lancet Infect Dis ; 18(11): e362-e367, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-29980383

RESUMEN

The Maputo Declaration of 2008 advocated for commitment from global stakeholders and national governments to prioritise support and harmonisation of laboratory systems through development of comprehensive national laboratory strategies and policies in sub-Saharan Africa. As a result, HIV laboratory medicine in Africa has undergone a transformation, and substantial improvements have been made in diagnostic services, networks, and institutions, including the development of a competent workforce, introduction of point-of-care diagnostics, and innovative quality improvement programmes that saw more than 1100 laboratories enrolled and 44 accredited to international standards. These improved HIV laboratories can now be used to combat emerging continental and global health threats in the decades to come. For instance, the unprecedented Ebola virus disease outbreak in west Africa exposed the severe weaknesses in the overall national health systems in affected countries. It is now possible to build robust health-care systems in Africa and to combat emerging continental and global health threats in the future. In this Personal View, we aim to describe the remarkable transformation that has occurred in laboratory medicine to combat HIV/AIDS and improve global health in sub-Saharan Africa since 2008.


Asunto(s)
Técnicas de Laboratorio Clínico/métodos , Enfermedades Transmisibles Emergentes/diagnóstico , Servicios de Diagnóstico/organización & administración , Infecciones por VIH/diagnóstico , África del Sur del Sahara , Servicios de Diagnóstico/historia , Política de Salud , Historia del Siglo XX , Historia del Siglo XXI , Humanos
19.
Expert Rev Mol Diagn ; 18(4): 385-397, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29658382

RESUMEN

INTRODUCTION: Simple, rapid tests that can be used at the point-of-care (POC) can improve access to diagnostic services and overall patient management in resource-limited settings where laboratory infrastructure is limited. Implementation of POC tests places tremendous strain on already fragile health systems as the demand for training, supply management and quality assurance are amplified. Digital health has a major role to play in ensuring effective delivery and management of POC testing services. Area covered: The ability to digitise laboratory and POC platforms, including lateral flow rapid diagnostic test results, can standardize the interpretation of results and allows data to be linked to proficiency testing to ensure testing quality, reducing interpretation and transcription errors. Remote monitoring of POC instrument functionality and utilization through connectivity, allows programs to optimize instrument placement, algorithm adoption and supply management. Alerts can be built into the system to raise alarm at unusual trends such as outbreaks. Expert commentary: Digital technology has had a powerful impact on POC testing in resource limited settings. Technology, markets, and medical devices have matured to enable connected diagnostics to become a useful tool for epidemiology, patient care and tracking, research, and antimicrobial resistance and outbreak surveillance. However, to unlock this potential, digital tools must first add value at the point of patient care. The global health community need to propose models for protecting intellectual property to foster innovation and for safeguarding data confidentiality.


Asunto(s)
Pruebas en el Punto de Atención/tendencias , Algoritmos , Seguridad Computacional/normas , Confidencialidad , Métodos Epidemiológicos , Salud Global/tendencias , Humanos , Técnicas de Diagnóstico Molecular/instrumentación , Técnicas de Diagnóstico Molecular/tendencias , Monitoreo Fisiológico , Sistemas de Atención de Punto/tendencias , Garantía de la Calidad de Atención de Salud
20.
J Infect Dis ; 217(7): 1060-1068, 2018 03 13.
Artículo en Inglés | MEDLINE | ID: mdl-29294035

RESUMEN

Epidemics of dengue, Zika, and other arboviral diseases are increasing in frequency and severity. Current efforts to rapidly identify and manage these epidemics are limited by the short diagnostic window in acute infection, the extensive serologic cross-reactivity among flaviviruses, and the lack of point-of-care diagnostic tools to detect these viral species in primary care settings. The Partnership for Dengue Control organized a workshop to review the current landscape of Flavivirus diagnostic tools, identified current gaps, and developed strategies to accelerate the adoption of promising novel technologies into national programs. The rate-limiting step to bringing new diagnostic tools to the market is access to reference materials and well-characterized clinical samples to facilitate performance evaluation. We suggest the creation of an international laboratory-response consortium for flaviviruses with a decentralized biobank of well-characterized samples to facilitate assay validation. Access to proficiency panels are needed to ensure quality control, in additional to in-country capacity building.


Asunto(s)
Anticuerpos Antivirales/sangre , Dengue/diagnóstico , Infección por el Virus Zika/diagnóstico , Anticuerpos Antivirales/inmunología , Seguridad de Productos para el Consumidor , Dengue/historia , Dengue/virología , Virus del Dengue/genética , Virus del Dengue/inmunología , Virus del Dengue/aislamiento & purificación , Ensayo de Inmunoadsorción Enzimática/historia , Ensayo de Inmunoadsorción Enzimática/métodos , Ensayo de Inmunoadsorción Enzimática/tendencias , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Vigilancia de la Población , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/historia , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/tendencias , Sensibilidad y Especificidad , Virus Zika/genética , Virus Zika/inmunología , Virus Zika/aislamiento & purificación , Infección por el Virus Zika/historia , Infección por el Virus Zika/virología
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