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Publications (444)
The acceptability and feasibility of large-scale testing with lateral flow tests (LFTs) for clinical and public health purposes has been demonstrated during the COVID-19 pandemic. LFTs can detect analytes in a variety of samples, providing a rapid read-out, which allows self-testing and decentralized diagnosis. In this Review, we examine the changi...
Throughout the COVID-19 pandemic, we have witnessed the critical and expanding roles of testing. Despite the development of over a thousand brand of tests - with some close to fulfilling the 4As (accuracy, access, affordability, and actionability via quick time to result) of an ideal diagnostic test - gaps persisted in developing tests to fit publi...
Diagnostic capacity is a key part of public and global health preparedness for newly emerging or spreading infections and the recent global spread of monkeypox illustrates the consequences of inadequate diagnostic capacity. Monkeypox has a syndromic diversity, from asymptomatic infection to isolated skin lesions, to fever and disseminated rash.1,2...
Background
Development and evaluation of diagnostics for diseases of epidemic potential are often funded during epidemics, but not afterwards, leaving countries unprepared for the next epidemic. United Nations Children's Emergency Fund (UNICEF) partnered with the United States Agency for International Development (USAID) to address this important g...
Tucker JD, Manderson L, Amazigo U, et alSocial innovation in health: concepts and practice BMJ Innovations Published Online First: 08 June 2022. doi: 10.1136/bmjinnov-2022-000982
Editorial opening BMJ Innovations special supplement on social innovation in health.
Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in in...
Global health research partnerships with institutions from high-income countries and low- and middle-income countries are one of the European Commission's flagship programmes. Here, we report on the ZikaPLAN research consortium funded by the European Commission with the primary goal of addressing the urgent knowledge gaps related to the Zika epidem...
Introduction
Left untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rate...
With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine performance with an excess risk of hospitalized and seve...
Dengue vaccination would enhance the control of dengue, one of the most frequent vector-borne viral diseases globally. CYD-TDV is the first dengue vaccine to be licensed, but global uptake has been hampered due to its use being limited to seropositive persons aged 9 years and above, and the need for a 3-dose schedule. The Partnership for Dengue Con...
WHO recommends a minimum of 80% sensitivity and 97% specificity for antigen-detection rapid diagnostic tests (Ag-RDTs), which can be used for patients with symptoms consistent with COVID-19. However, after the acute phase when viral load decreases, use of Ag-RDTs might lead to high rates of false negatives, suggesting that the tests should be repla...
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...
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, accele...
Halpaap BM, Tucker JD, Mathanga D. et al. Social innovation in global health: sparking location action. The Lancet Global Health. May 2020 vol 8(5): e633-e634. DOI: https://doi.org/10.1016/S2214-109X(20)30070-X https://www.sciencedirect.com/science/article/pii/S2214109X2030070X
Antimicrobial resistance (AMR) is a biological mechanism whereby a micro-organism evolves over time to develop the ability to become resistant to antimicrobial therapies such as antibiotics. The drivers of and potential solutions to AMR are complex, often spanning multiple sectors. The internationally recognised response to AMR advocates for a 'One...
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 STI...
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...
The Chlamydiae are pathogenic bacteria that can only replicate inside eukaryotic host cells and have a unique developmental cycle. The Chlamydiae have their own order (Chlamydiales) and family (Chlamydiaceae). Chlamydia trachomatis is the most common bacterial sexually transmitted infection and the leading infectious cause of blindness (trachoma, s...
This commentary highlights the value of community-engaged social innovations to advance health care delivery in low- and middle-income countries and to accelerate universal health coverage. It emphasizes the importance of research to guide the innovators on what works, what does not work to make their innovations sustainable and to replicate and sc...
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 c...
Can pre-vaccination screening for prior dengue infection using commercially available rapid diagnostic tests guide Dengvaxia administration?
Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infection...
Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infection...
Zika Preparedness Latin American Network (ZikaPLAN) is a research consortium funded by the European Commission to address the research gaps in combating Zika and to establish a sustainable network with research capacity building in the Americas. Here we present a report on ZikaPLAN`s mid-term achievements since its initiation in October 2016 to Jun...
Background:
Lassa fever virus has been enlisted as a priority pathogen of epidemic potential by the World Health organization Research and Development (WHO R & D) Blueprint. Diagnostics play a crucial role in epidemic preparedness. This systematic review was conducted to determine the sensitivity and specificity of Lassa fever diagnostic tests for...
Scale up of dual HIV and syphilis rapid diagnostic
tests could close the antenatal care syphilis testing
gap, providing an opportunity to deliver treatment
with injectable benzathine benzylpenicillin during
the same visit. Successful implementation of dual
HIV and syphilis rapid diagnostic tests in antenatal
care would increase syphilis screening r...
Neglected tropical diseases (NTDs) are the cause of much human suffering and death and pose a devastating challenge to health for millions of people. World Health Organization (WHO) efforts to combat NTDs culminated in the WHO’s 2011 “Accelerating work to overcome the global impact of NTDs: A Roadmap for implementation” (“Roadmap for implementation...
This chapter discusses the challenges of delivering HIV care in resource‐limited settings and the diagnostic tests needed to achieve the 90‐90‐90 goals. It describes recent advances in point‐of‐care (POC) tests for HIV diagnosis and monitoring, the impact they have and the remaining challenges. The chapter examines what is needed to revolutionize h...
The optimal features of a point‐of‐care (POC) diagnostic test can be summarized by ASSURED that is Afordable, Sensitive, Specific, User‐friendly, Rapid and Robust, Equipment‐free and Deliverable to end‐users. Ensuring the quality of both POC tests and that of testing performed at hundreds or thousands of different sites by healthcare workers, who a...
Point‐of‐care (POC) tests have been shown to increase the uptake of screening for syphilis in a variety of resource‐limited settings. The introduction of POC tests increased the proportion of antenatal care attenders screened for syphilis to 90%, and the proportion of pregnant women with syphilis who were treated the same day exceeded 90% in all co...
This chapter reviews the ongoing challenges in healthcare delivery and explores the use of drones as an innovation in the delivery of rural healthcare. The initial use of drones for health‐related purposes includes delivering aid packages to disaster areas as well as delivering blood and specimens, medicines and other medical supplies, vaccines, an...
There have been many lessons learnt in the implementation of point‐of‐care (POC) tests in resource‐limited settings. The development and deployment of simple rapid diagnostic tests that can be used by health providers at the POC is recognized as an urgent priority. In implementing rapid syphilis tests countries have found that, although there are c...
Background:Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infectio...
Background: Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infecti...
The emergence and spread of antimicrobial resistance is one of the major global issues currently threatening the health and wealth of nations, with effective guidelines and intervention strategies urgently required. Such guidelines and interventions should ideally be targeted at individuals, communities, and nations, requiring international coordin...
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 effic...
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 hi...
Objectives:
Vaccination for dengue with the live attenuated tetravalent CYD-TDV vaccine (Dengvaxia®) is only recommended in individuals who have had prior dengue virus (DENV) infection. Rapid diagnostic tests (RDT) for past DENV infection would offer a convenient method for pre-vaccination screening at point-of-care. A systematic review was conduc...
It has long been recognised that diagnosis is a critical component of healthcare, and without sufficiently accurate diagnosis treatment is difficult or not possible. Advanced laboratory-based systems have been developed over many years and now for many different analysis requirements and analytes it is possible to get a quantitative analysis. Devel...
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 publicatio...
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 Neisser...
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...
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....
: Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. While 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...
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,...
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 mana...
HIV serostatus disclosure before sex can facilitate serosorting, condom use and potentially decrease the risk of HIV acquisition. However, few studies have evaluated HIV serostatus disclosure from partners before sex. We examined the rate and correlates of receiving HIV serostatus disclosure from regular and casual male partners before sex among an...
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 diagnostics to detect these viral s...
Objectives:
The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM.
Methods:
The study was unde...
Background
WHO estimates that 131 million new cases of urogenital Chlamydia trachomatis (CT) infections occur globally every year. Most infections are asymptomatic. Untreated infection in women can lead to severe complications. Screening and treatment of at-risk populations is a priority for prevention and control.
Objectives
To summarise systemat...
Background
In 2012, there was an estimated 78 million new cases of gonorrhoea globally. Untreated infection may lead to reproductive and neonatal morbidity and facilitate HIV transmission. Diagnosis and treatment are a priority for control and prevention, yet use of point-of-care tests (POCTs) for Neisseria gonorrhoeae (NG) is limited.
Objectives...
Objectives
Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing.
Methods
Since 2014...
WHO recognises the global impact of sexually transmitted infections (STIs) on global public health and individual sexual and reproductive health and well-being. As a component of the WHO Global Health Sector Strategy for the control and prevention of STIs, there has been a growing recognition of the importance of integrating point-of-care tests (PO...
Background
High-risk human papillomavirus (HPV) is a necessary cause of high-grade cervical intraepithelial neoplasia (grade 2 or higher, CIN2+). Simplified and rapid HPV DNA assays designed for use in resource-limited settings have recently become available.
Methods
We performed a systematic review and meta-analysis by searching Medline, Embase,...
The rise of antimicrobial resistance is a global threat and Africa like any other developing setting is heavily affected. As one of its missions, the Africa CDC is poised to ensure this rising trend takes a diminishing route in the few years ahead. Diagnostics obviously play a pivotal role in AMR control and the advanced course in diagnostics (ACDx...
A large burden of undiagnosed hepatitis virus cases remains globally. Despite the 257 million people living with chronic hepatitis B virus infection, and 71 million with chronic viraemic HCV infection, most people with hepatitis remain unaware of their infection. Advances in rapid detection technology have created new opportunities for enhancing ac...
Background
Although direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessm...
Background
Chronic Hepatitis B Virus (HBV) infection is characterised by the persistence of hepatitis B surface antigen (HBsAg). Expanding HBV diagnosis and treatment programmes into low resource settings will require high quality but inexpensive rapid diagnostic tests (RDTs) in addition to laboratory-based enzyme immunoassays (EIAs) to detect HBsA...
Background
Innovation contests are a novel approach to elicit good ideas and innovative practices in various areas of public health. There remains limited published literature on approaches to deliver hepatitis testing. The purpose of this innovation contest was to identify examples of different hepatitis B and C approaches to support countries in...