Universal access to malaria diagnostic testing: an operational manual

The aim of this interagency manual is to provide policy, strategy, technical and operational guidance to countries wishing to strengthen or set up routine malaria diagnostic services. These services include the use of both microscopy and rapid diagnostic tests (RDTs) at all levels for the management of febrile patients by health workers and are integrated within other national programmes for strengthening laboratory services. This operational guide is primarily for national, provincial and district health and laboratory managers in ministries of health and malaria control programme and for the managers of other health agencies, nongovernmental organizations and faith-based organizations working with national health authorities to strengthen malaria diagnostic services. The manual starts with a section on programme aspects (section 1), followed by descriptions of the policies and guidelines that are needed in a programme to strengthen malaria diagnostic testing (section 2). The various activities are then described (sections 3-7), with the different aspects of monitoring and surveillance (sections 8 and 9). Strategies for particular settings are briefly proposed in section 10. Although the general approach is directed to programme management, some sections and tools might be useful for designing training materials and standard operating procedures for health professionals (doctors, nurses and health officers) and laboratory staff (scientists, technicians and microscopists) working in programmes for the diagnosis and treatment of patients with malaria. Most of the tools are described in the annexes to this manual. This manual is a synthesis of important issues published previously, presented in an accessible format, and is intended to give a practical approach to establishing a reliable system for malaria diagnostic testing. References to WHO publications available online, which provide more detailed information, are listed throughout this manual and in the annexes. The manual is intended to provide general guidance, which may help countries to prepare or revise their operational manuals by involving national health authorities and technical partners active in this area of work. For example, the manual makes reference to health facility support to community health workers in conducting malaria diagnostic testing at community level. These sections might not be relevant to all countries. The aim of the manual is to stimulate the development of malaria diagnostic testing and management, not as a vertical programme but integrated with activities at various levels of the health system. A key condition for its success is that malaria diagnostic testing not be practised on its own but as one component of the management of febrile patients, including causes of fever other than malaria. Experience in several countries (Burkina Faso, Ghana, Nigeria, Papua New Guinea, Uganda, the United Republic of Tanzania (including Zanzibar) and Zambia) has shown that, with good training and support, health workers adhere to the results of malaria tests and treat only positive patients. This manual provides technical guidance on who should be tested for malaria and how. This is a major shift from other criteria for deciding who should be treated for malaria. It aligns the management of malaria with that of any other disease for which a reliable diagnostic test is universal access to malaria diagnostic testing: An operational manual available. When the terms 'RDT' and 'microscopy' are used in a recommendation, it is considered as implicit that the tests are quality assured and therefore that they provide reliable, reproducible results in line with their technical characteristics. When not explicitly mentioned, the statements in the manual apply to all Plasmodium species (falciparum and non-falciparum). This manual is intended to be read comprehensively, although some sections and tools given in the annexes can stand alone.Foreword -- Abbreviations -- Acknowledgments -- Glossary -- Preamble. -- Introduction. -- 1. Programme Planning and Management. -- 1.1 Terms of reference for the national coordination group on malaria diagnosis. -- 1.2 Situation analysis and gap identification. -- 1.3 Roles and responsibilities. -- 2. Policies and Technical Guidelines. -- 2.1 Update relevant national policies -- 2.2 Address regulatory issues -- 2.3 Prepare national guidelines. -- 2.4 Prepare an implementation plan -- 3. Procurement and Logistics of Malaria Tests. -- 3.1 Selection of products for malaria diagnosis . -- 3.2 Quantification and forecasting of requirements for malaria testing. -- 3.3 Procurement of supplies for malaria testing. -- 3.4 Distribution, transport and storage -- 3.5 Stock management -- 3.6 Maintenance of microscopes and other equipment. -- 4. Components of the Quality Management System -- 4.1 Overview of quality management at different levels -- 4.2 Quality management activities at central level. -- 4.3 Quality management activities at subnational level -- 4.4 Quality assessment at points of care -- 4.5 Action to be taken in cases of nonconformity with malaria testing. -- 4.6 Country scenarios. -- 5. Training of Health Workers and Supervisors -- 5.1 Sensitization. -- 5.2 Organization of in-house training at all levels. -- 5.3 Integration into pre-service training. -- 5.4 Training in integrated management of fever -- 6. Supervision at Points of Care (Health Facilities and the Community) -- 7. Information, Education and Communication -- 7.1 Preparing a communication plan -- 7.2 Roles and responsibilities. -- 8. Monitoring and Evaluating Tte Programme -- 8.1 Establishing indicators and monitoring -- 8.2 Trouble-shooting, investigation and response -- 9. Expected Impact on Malaria Surveillance -- 10. Diagnostic Strategies in Particular Settings -- 10.1 Advanced malaria control and pre-elimination. -- 10.2 Areas in which malaria has been eliminated -- 10.3 Non-endemic areas. -- 10.4 Endemic-prone areas -- 10.5 Complex emergencies. -- Resource documents -- Annex 1. Standard operating procedures for the use, care and maintenance of microscopes -- Annex 2. Specification sheet for laboratory equipment. -- Annex 3. Maintenance service report for laboratory equipment. -- Annex 4. Register for maintenance of laboratory equipment -- Annex 5. Standard operating procedures for storage of rapid diagnostic tests at points of care. -- Annex 6. Standard operating procedures for management of wastes from malaria diagnostic tests -- Annex 7. Testing for proficiency in reading blood slides against reference slides -- Annex 8. Checklist for supervision of laboratories performing malaria testing -- Annex 9. Checklist for direct observation of laboratory technicians performing malaria microscopy -- Annex 10. Checklist for direct observation of health workers performing rapid diagnostic tests for malaria -- Annex 11. Case scenarios for training in use of rapid diagnostic tests in clinical management -- Annex 12. Checklist for supervision of malaria diagnostic testing in health facilities -- Annex 13. Checklist for supervision of clinical management of febrile children at health facility level.The manual has been developed from a draft framework document jointly prepared by the WHO Global Malaria Programme (WHO/GMP) and the US Centers for Disease Control and Prevention (CDC) in 2009, named "Malaria Diagnosis: An Operational Guideline for Strengthening Malaria Diagnostic Services". This document was shared in March 2010 with the members of the diagnostic work-stream of the Roll Back Malaria Case Management Working Group, to serve as a basis for further development into a new inter-agency manual on universal access to diagnostic testing of malaria.Available via the World Wide Web as an Acrobat .pdf file (2.15 MB, 160 p.)

Challenges for clinical practice and research in family medicine in reducing the risk of chronic diseases. Notes on the EGPRN Spring Conference 2017 in Riga

publishersversionPeer reviewe

WHO fungal priority pathogens list to guide research, development and public health action

Infectious diseases are among the top causes of mortality and a leading cause of disability worldwide. Drug-resistant bacterial infections are estimated to directly cause 1.27 million deaths and to contribute to approximately 4.95 million deaths every year, with the greatest burden in resource- limited settings. Against the backdrop of this major global health threat, invasive fungal diseases (IFDs) are rising overall and particularly among immunocompromised populations. The diagnosis and treatment of IFDs are challenged by limited access to quality diagnostics and treatment as well as emergence of antifungal resistance in many settings. Despite the growing concern, fungal infections receive very little attention and resources, leading to a paucity of quality data on fungal disease distribution and antifungal resistance patterns. Consequently, it is impossible to estimate their exact burden. In 2017, WHO developed its first bacterial priority pathogens list (WHO BPPL) in the context of increasing antibacterial resistance to help galvanize global action, including the research and development (R&D) of new treatments. Inspired by the BPPL, WHO has now developed the first fungal priority pathogens list (WHO FPPL). The WHO FPPL is the first global effort to systematically prioritize fungal pathogens, considering their unmet R&D needs and perceived public health importance. The WHO FPPL aims to focus and drive further research and policy interventions to strengthen the global response to fungal infections and antifungal resistance. The development of the list followed a multicriteria decision analysis (MCDA) approach. The prioritization process focused on fungal pathogens that can cause invasive acute and subacute systemic fungal infections for which drug resistance or other treatment and management challenges exist. The pathogens included were ranked, then categorized into three priority groups (critical, high, and medium). The critical group includes Cryptococcus neoformans, Candida auris, Aspergillus fumigatus and Candida albicans. The high group includes Nakaseomyces glabrata (Candida glabrata), Histoplasma spp., eumycetoma causative agents, Mucorales, Fusarium spp., Candida tropicalis and Candida parapsilosis. Finally, pathogens in the medium group are Scedosporium spp., Lomentospora prolificans, Coccidioides spp., Pichia kudriavzeveii (Candida krusei), Cryptococcus gattii, Talaromyces marneffei, Pneumocystis jirovecii and Paracoccidioides spp. This document proposes actions and strategies for policymakers, public health professionals and other stakeholders, targeted at improving the overall response to these priority fungal pathogens, including preventing the development of antifungal drug resistance. Three primary areas for action are proposed, focusing on: (1) strengthening laboratory capacity and surveillance; (2) sustainable investments in research, development, and innovation; and (3) public health interventions. Countries are encouraged to improve their mycology diagnostic capacity to manage fungal infections and to perform surveillance. In most contexts, this might require a stepwise approach. There is a need for sustainable investments in research, development, and innovation. More investments are needed in basic mycology research, R&D of antifungal medicines and diagnostics. Innovative approaches are needed to optimize and standardize the use of current diagnostic modalities globally. In addition, public health interventions are needed to highlight the importance of fungal infections, including through incorporating fungal diseases and priority pathogens in medical (clinical) and public health training programmes and curricula at all levels of training. Similarly, collaboration across sectors is required to address the impact of antifungal use on resistance across the One Health spectrum. Finally, regional variations and national contexts need to be taken into consideration while implementing the WHO FPPL to inform priority actions.S

Evasion of the Interferon-Mediated Antiviral Response by Filoviruses

The members of the filoviruses are recognized as some of the most lethal viruses affecting human and non-human primates. The only two genera of the Filoviridae family, Marburg virus (MARV) and Ebola virus (EBOV), comprise the main etiologic agents of severe hemorrhagic fever outbreaks in central Africa, with case fatality rates ranging from 25 to 90%. Fatal outcomes have been associated with a late and dysregulated immune response to infection, very likely due to the virus targeting key host immune cells, such as macrophages and dendritic cells (DCs) that are necessary to mediate effective innate and adaptive immune responses. Despite major progress in the development of vaccine candidates for filovirus infections, a licensed vaccine or therapy for human use is still not available. During the last ten years, important progress has been made in understanding the molecular mechanisms of filovirus pathogenesis. Several lines of evidence implicate the impairment of the host interferon (IFN) antiviral innate immune response by MARV or EBOV as an important determinant of virulence. In vitro and in vivo experimental infections with recombinant Zaire Ebola virus (ZEBOV), the best characterized filovirus, demonstrated that the viral protein VP35 plays a key role in inhibiting the production of IFN-α/β. Further, the action of VP35 is synergized by the inhibition of cellular responses to IFN-α/β by the minor matrix viral protein VP24. The dual action of these viral proteins may contribute to an efficient initial virus replication and dissemination in the host. Noticeably, the analogous function of these viral proteins in MARV has not been reported. Because the IFN response is a major component of the innate immune response to virus infection, this chapter reviews recent findings on the molecular mechanisms of IFN-mediated antiviral evasion by filovirus infection

Stated preferences over job characteristics: a panel study

When making choices over jobs with different characteristics, what trade‐offs are decision‐makers willing to make? Such a question is difficult to address using typical household surveys that provide a limited amount of information on the attributes of the jobs. To address this question, a small but growing number of studies have turned to the use of stated preference experiments; but the extent to which stated choices by respondents reflect systematic trade‐offs across job characteristics remains an open question. We use two popular types of experiments (profile case best–worst scaling and multi‐profile case best–worst scaling) to elicit job preferences of nursing students and junior nurses in Australia. Each person participated in both types of experiments twice, within a span of about 15 months. Using a novel joint likelihood approach that links a decision‐maker's preferences across the two types of experiments and over time, we find that the decision‐makers make similar trade‐offs across job characteristics in both types of experiments and in both time periods, except for the trade‐off between salary and other attributes. The valuation of salary falls significantly over time relative to other job attributes for both types of experiments. Also, within each period, salary is less valued in the profile case compared to the more traditional multi‐profile case

Provision of medical abortion by midlevel healthcare providers in Kyrgyzstan : testing an intervention to expand safe abortion services to underserved rural and periurban areas

Publisher Copyright: © 2017 World Health OrganizationObjective: To demonstrate the feasibility and safety of training midlevel healthcare providers (midwives and family nurses) to provide medical abortion and postabortion contraception in underserved areas in Kyrgyzstan. Study design: This was an implementation study at four referral facilities and 28 Felsher Obstetric Points in two districts to train their midwives and family nurses to deliver safe and effective abortion care with co-packaged mifepristone–misoprostol and provide contraceptives postabortion. The outcome of abortion — complete abortion, incomplete abortion or o-going pregnancy — was the primary end point measured. An international consultant trained 18 midwives and 14 family nurses (with midwifery diplomas) to provide medical abortion care. Supervising gynecologists based in the referral centers and study investigators based in Bishkek provided monthly monitoring of services and collection of patient management forms. A voluntary self-administered questionnaire at the follow-up visit documented women's acceptability of medical abortion services. All study data were cross-checked and entered into an online data management system for descriptive analysis. Results: Between August 2014 and September 2015, midwives provided medical abortion to 554 women with a complete abortion rate of 97.8%, of whom 62% chose to use misoprostol at home. No women were lost to follow-up. Nearly all women (99.5%) chose a contraceptive method postabortion; 61% of women receiving services completed the acceptability form, of whom more than 99% indicated a high level of satisfaction with the service and would recommend it to a friend. Conclusion: This study demonstrates that trained Kyrgyz midwives and nurses can provide medical abortion safely and effectively. This locally generated evidence can be used by the Kyrgyz Ministry of Health to reduce unintended pregnancy and expand safe abortion care to women in underserved periurban and rural settings. Implications: Success in scaling up midwife/nurse provision of medical abortion in Kyrgyzstan will require registration of mifepristone–misoprostol, regulations permanently allowing midwife/nurse provision, strengthened procurement and distribution systems to prevent stockouts of supplies, preservice training of midwives/nurses and their involvement in district level supervision, monitoring and reporting, and support from supervisors.publishersversionPeer reviewe

Prices and availability of locally produced and imported medicines in Ethiopia and Tanzania

Background: To assess the effect of policies supporting local medicine production to improve access to medicines. Methods: We adapted the WHO/HAI instruments measuring medicines availability and prices to differentiate local from imported products, then pilot tested in Ethiopia and Tanzania. In each outlet, prices were recorded for all products in stock for medicines on a country-specific list. Government procurement prices were also collected. Prices were compared to an international reference and expressed as median price ratios (MPR). Results: The Ethiopian government paid more for local products (median MPR = 1.20) than for imports (median MPR = 0.84). Eight of nine medicines procured as both local and imported products were cheaper when imported. Availability was better for local products compared to imports, in the public (48% vs. 19%, respectively) and private (54% vs. 35%, respectively) sectors. Patient prices were lower for imports in the public sector (median MPR = 1.18[imported] vs. 1.44[local]) and higher in the private sector (median MPR = 5.42[imported] vs. 1.85[local]). In the public sector, patients paid 17% and 53% more than the government procurement price for local and imported products, respectively. The Tanzanian government paid less for local products (median MPR = 0.69) than imports (median MPR = 1.34). In the public sector, availability of local and imported products was 21% and 32% respectively, with patients paying slightly more for local products (median MPR = 1.35[imported] vs. 1.44[local]). In the private sector, local products were less available (21%) than imports (70%) but prices were similar (median MPR = 2.29[imported] vs. 2.27[local]). In the public sector, patients paid 135% and 65% more than the government procurement price for local and imported products, respectively. Conclusions: Our results show how local production can affect availability and prices, and how it can be influenced by preferential purchasing and mark-ups in the public sector. Governments need to evaluate the impact of local production policies, and adjust policies to protect patients from paying more for local products.Scopu

Challenges to reduce the ‘10/90 gap’: mental health research in Latin American and Caribbean countries

Razzouk D, Gallo C, Olifson S, Zorzetto R, Fiestas F, Poletti G, Mazzotti G, Levav I, Mari JJ. Challenges to reduce the ‘10/90 gap’: mental health research in Latin American and Caribbean countries