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Background: In Africa, little is known about the role of telephone hotlines in outbreak response. We systematically reviewed the role and effectiveness of hotlines on outbreak response in Africa. Method: We used the Cochrane handbook and searched five databases. The protocol was registered on PROSPERO (CRD42021247141). Medline, Embase, PsycINFO, Global Health and Web of Science were searched from 30 June 2020 to August 2020 for studies on the use of telephone hotlines in outbreak response in Africa published between January 1995 and August 2020. The search was also repeated on 16 September 2022. Data on effectiveness (alerts generated, cases confirmed) were extracted from peer-reviewed studies. Meta-analysis of alerts generated, and proportion of cases confirmed was done using the random effects model. The quality of studies was assessed using the Joanna Briggs Institute (JBI) tools. The heterogeneity and publication bias were assessed using the Galbraith and funnel plots, respectively. Results: Our search yielded 1251 non-duplicate citations that were assessed. 41 full texts were identified, and 21 studies were included in the narrative synthesis, while 12 were included in the meta-analysis. The hotlines were local (seven studies) or national (three studies). A combination of a local and national hotline was used in one study. The hotlines were set up for unusual respiratory events (one study), polio (one study), Ebola (10 studies), COVID-19 (two studies), malaria (one study), influenza-like illnesses (ILI) (one study) and rift valley fever in livestock (one study). Hotlines were mainly used for outbreak surveillance at the local level. A total of 332,323 alerts were generated, and 67,658 met the case definition, corresponding to an overall pooled proportion of alerts generated(sensitivity) of 38% (95%CI: 24–52%). The sensitivity was 41% (95% CI: 24–59%) for local hotlines and 26%(95%CI:5–47%) for national hotlines. Hotlines were also used for surveillance of rift valley fever in livestock (one study) vaccination promotion (one study), death reporting (five studies), rumour tracking and fighting misinformation (two studies) and community engagement (five studies). The studies were of low to moderate quality with high publication bias and heterogeneity(I2 = 99%). The heterogeneity was not explained by the sample size. Conclusion: These data suggest that telephone hotlines can be effective in outbreak disease surveillance in Africa. Further implementation research is needed to scale up telephone hotlines in rural areas. [ABSTRACT FROM AUTHOR]

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events of international public health importance. [ABSTRACT FROM AUTHOR]

It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing. [ABSTRACT FROM AUTHOR]

Background Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC). Methods Data was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States. Results Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices. Conclusions Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic has ushered us into a new era of global public health urgency, with diagnostics and laboratory medicine at its centre.[1] To take advantage of this focus on diagnostics to leapfrog some of the barriers in low- and middle-income countries, we must first understand what is feasible and effective in our setting. A well-connected diagnostic system will cause a seismic shift in the way disease control is tackled in Africa. Connectivity of new and existing point-of-care diagnostics should be fully functional and integrated with laboratory services to form connected diagnostic systems that will support disease surveillance and outbreak responses. [Extracted from the article]

Focuses on efforts in developing countries to prevent the maternal-fetal transmission of syphilis. Efforts of the Haitian government to provide prenatal care that includes treatment for a variety of maternal diseases; Negative impact of maternal syphilis on infant illness and mortality; Prevalence of maternal syphilis infection in sub-Saharan Africa and Haiti; Potential impact of standard syphilis screening in prenatal care on maternal and infant health.

The article offers information regarding the importance of implementing quality assurance for laboratory and diagnostic testing in Africa. It discusses the point-of-care sites across the continent as well as the effort of the World Health Organization in providing leadership through several landmark events including the Maputo Declaration for strengthening laboratory health systems.

Summary: Background: Antibiotics are an important part of WHO's strategy to eliminate trachoma as a blinding disease by 2020. At present, who needs to be treated is unclear. We aimed to establish the burden of ocular Chlamydia trachomatis in three trachoma-endemic communities in Tanzania and The Gambia with real-time quantitative PCR. Methods: Conjunctival swabs were obtained at examination from 3146 individuals. Swabs were first tested by the qualitative Amplicor PCR, which is known to be highly sensitive. In positive samples, the number of copies of omp1 (a single-copy C trachomatis gene) was measured by quantitative PCR. Findings: Children had the highest ocular loads of C trachomatis, although the amount of pooling in young age groups was less striking at the site with the lowest trachoma frequency. Individuals with intense inflammatory trachoma had higher loads than did those with other conjunctival signs. At the site with the highest prevalence of trachoma, 48 of 93 (52%) individuals with conjunctival scarring but no sign of active disease were positive for ocular chlamydiae. Interpretation: Children younger than 10 years old, and those with intense inflammatory trachoma, probably represent the major source of ocular C trachomatis infection in endemic communities. Success of antibiotic distribution programmes could depend on these groups receiving effective treatment. [ABSTRACT FROM AUTHOR]

There are inefficiencies in current approaches to monitoring patients on antiretroviral therapy in sub-Saharan Africa. Patients typically attend clinics every 1 to 3 months for clinical assessment. The clinic costs are comparable with the costs of the drugs themselves and CD4 counts are measured every 6 months, but patients are rarely switched to second-line therapies. To ensure sustainability of treatment programmes, a transition to more cost-effective delivery of antiretroviral therapy is needed. In contrast to the CD4 count, measurement of the level of HIV RNA in plasma (the viral load) provides a direct measure of the current treatment effect. Viral-load-informed differentiated care is a means of tailoring care so that those with suppressed viral load visit the clinic less frequently and attention is focussed on those with unsuppressed viral load to promote adherence and timely switching to a second-line regimen. The most feasible approach to measuring viral load in many countries is to collect dried blood spot samples for testing in regional laboratories; however, there have been concerns over the sensitivity and specificity of this approach to define treatment failure and the delay in returning results to the clinic. We use modelling to synthesize evidence and evaluate the cost-effectiveness of viral-load-informed differentiated care, accounting for limitations of dried blood sample testing. We find that viral-load-informed differentiated care using dried blood sample testing is cost-effective and is a recommended strategy for patient monitoring, although further empirical evidence as the approach is rolled out would be of value. We also explore the potential benefits of point-of-care viral load tests that may become available in the future.

Improved diagnostic tests for tuberculosis case detection are urgently needed that are affordable, robust, and easy to use so that they can be implemented widely. The mandate of national regulatory authorities is to ensure the safety and effectiveness of diagnostics, protecting the population against unsafe products while expediting access to beneficial new devices. However, regulatory approval processes in the developing world are often complex, lengthy, and not transparent. Recent progress in building regulatory capacity using harmonized approaches will reduce duplication in clinical performance studies and manufacturing audits, facilitate information sharing through trust and mutual confidence building, and ultimately improve efficiency. These savings can be passed onto the consumers in the form of more affordable pricing and allowing new high-quality tests for tuberculosis to be introduced more quickly and without delay., (© The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)