National Laboratory System

  • Association for Public Health Laboratories. (2013). Sierra Leone and Guinea: Strengthening Public Health Laboratories. Silver Spring: APHL.
    • The world’s most widespread epidemic of Ebola Virus Disease (EVD) began around December 2013. Within six months, cases were found throughout Guinea, Liberia and Sierra Leone. Initial response was marked by disease surveillance gaps and weaknesses but heroic efforts eventually led to monumental successes. This report documents those successes and was created through a series of interviews with laboratory leaders and review of formal reports. 
  • Balajee SA, Arthur R, Mounts AW. (2016). Global Health Security: Building Capacities for Early Event Detection, Epidemiologic Workforce, and Laboratory Response. Health Security, 14(6), 424-32.              
    • The Global Health Security Agenda (GHSA) was launched in February 2014 to bring countries with limited capacity into compliance with the International Health Regulations (IHR) (2005). Recent international public health events, such as the appearance of Middle Eastern respiratory syndrome coronavirus and the reappearance of Ebola in West Africa, have highlighted the importance of early detection of disease events and the interconnectedness of countries. Surveillance systems that allow early detection and recognition of signal events, a public health infrastructure that allows rapid notification and information sharing within countries and across borders, a trained epidemiologic workforce, and a laboratory network that can respond appropriately and rapidly are emerging as critical components of an early warning and response system. This article focuses on 3 aspects of the GHSA that will lead to improved capacities for the detection and response to outbreaks as required by the IHR: (1) early detection and reporting of events, (2) laboratory capacity, and (3) a trained epidemiologic workforce.
  • Best M, Sakande J. (2016). Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era. African Journal of Laboratory Medicine, 5(3), 1-10.       
    • The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. This article presents recommendations based on 17 years of network development experiences for the development of effective national laboratory networks.
  • Borchert JN, Tappero JW, et al. (2014). Rapidly Building Global Health Security Capacity — Uganda Demonstration Project, 2013. Morbidity and Mortality Weekly Report, 63(4), 73-76.
    • Increasingly, the need to strengthen global capacity to prevent, detect, and respond to public health threats around the globe is being recognized. This article details a capacity building process conducted from March–September 2013, when the Uganda Ministry of Health and CDC partnered to implement upgrades in three areas: (1) strengthening the public health laboratory system by increasing the capacity of diagnostic and specimen referral networks, (2) enhancing the existing communications and information systems for outbreak response, and (3) developing a public health emergency operations center. In 6 months, the project demonstrated that targeted enhancements resulted in substantial improvements to the ability of Uganda’s public health system to detect and respond to health threats.
  • Broadhurst MJ, Brooks TJ, Pollock NR. (2016). Diagnosis of Ebola Virus Disease: Past, Present, and Future. Clinical Microbiology Reviews, 29(4), 773-93.             
    • Laboratory diagnosis of Ebola virus disease plays a critical role in outbreak response efforts; however, establishing safe and expeditious testing strategies for this high-biosafety-level pathogen in resource-poor environments remains extremely challenging. These authors describe the evolution of Ebola virus disease diagnostic testing and efforts to deploy field diagnostic laboratories in prior outbreaks. The article explores the diagnostic challenges pervading the 2014-2015 epidemic and provides a comprehensive examination of novel diagnostic tests that are likely to address some of these challenges moving forward.
  • Caliendo AM, Gilbert DN, Ginocchio CC, et al. (2013). Better Tests, Better Care: Improved Diagnostics for Infectious Diseases. Clinical Infectious Diseases, 57(S3), 139-70.         
    • This IDSA policy paper reviews the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill the promise of emerging diagnostics, IDSA presents recommendations that address a host of identified barriers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including government, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and health care providers.
  • Centers for Disease Control and Prevention. (2014). The Laboratory Response Network Partners in Preparedness. Atlanta: CDC.    
    • The Laboratory Response Network (LRN) is a national security asset that, with its partners, will develop, maintain and strengthen an integrated domestic and international network of laboratories to respond quickly to biological, chemical, and radiological threats and other high priority public health emergencies needs through training, rapid testing, timely notification and secure messaging of laboratory results.
  • Centers for Disease Control and Prevention, World Health Organization Regional Office for Africa, USAID. (2008). Guide for National Public Health Laboratory Networking to Strengthen Integrated Disease Surveillance and Response (IDSR).
    • This guideline presents recommendations that can be applied to multi-disease laboratory networks, with a particular emphasis placed on providing laboratory data for high priority bacterial diseases. The purpose of the document is to: (i) define the purpose of a public health laboratory network, (ii) define the components of a public health laboratory network, (iii) describe the coordination of a laboratory network, (iv) provide general guidance for establishing and strengthening a national laboratory network, and (v) promote linkages with WHO collaborating centers, other international laboratories and specific disease program partners.
  • Deshpande A, McMahon B, Daughton AR, et al. (2016). Surveillance for Emerging Diseases with Multiplexed Point-of-Care Diagnostics. Health Security, 14(3), 111-21.
    • These authors present an analysis of the diagnostic technologies that were used to identify historical outbreaks of Ebola virus disease and consider systematic surveillance strategies that may greatly reduce the peak size of future epidemics. They observe that clinical signs and symptoms alone are often insufficient to recognize index cases of diseases of global concern against the considerable background infectious disease burden that is present throughout the developing world. Because of this, they propose a simple sampling strategy to enrich in especially dangerous pathogens with a low background for molecular diagnostics by targeting blood-borne pathogens in the healthiest age groups.
  • Dickmann P, Apfel F, Biedenkopf N, et al. (2015). Marburg Biosafety and Biosecurity Scale (MBBS), A Framework for Risk Assessment and Risk Communication. Health Security, 13(2), 88-95.
    • Current risk assessment and risk communication of biosafety and biosecurity concerns lack a convenient metric and conceptual framework. The absence of such a systematic tool makes communication more difficult and can lead to an ambiguous public perception of and response to laboratory biosafety incidents and biosecurity threats. These authors propose a new 7-category scoring scale is proposed for incidents and situations in laboratories related to the handling of human and animal pathogens. The scale aims to help clarify risk categories, facilitate coordination and communication, and improve public understanding of risk related to biosafety and biosecurity. 
  • Fonjungo PN, Alemnji GA, Kebede Y, et al. (2017). Combatting Global Infectious Diseases: A Network Effect of Specimen Referral Systems. Clinical Infectious Diseases, 64(6), 796-803.    
    • The recent Ebola virus outbreak in West Africa clearly demonstrated the critical role of laboratory systems and networks in responding to epidemics. Because of the huge challenges in establishing functional laboratories at all tiers of health systems in developing countries, strengthening specimen referral networks is critical. This review proposes a platform strategy for developing specimen referral networks based on two models: centralized and decentralized laboratory specimen referral networks.
  • Frean J, Perovic O, Fensham V, et al. (2012). External quality assessment of national public health laboratories in Africa, 2002-2009. Bulletin of the World Health Organization, 90, 191-99.
    • In many African countries, reliable confirmation of suspected infectious diseases is hampered by a lack of standardized diagnostic methods and by a shortage of funds, staff and laboratory supplies for national public health laboratories, despite the critical role played by these laboratories as part of a functional infrastructure for disease surveillance. In 200, WHO launched an external quality assessment programme (EQAP) to test the proficiency of microbiological testing for epidemic-prone diseases by laboratories in the African Region. This article reviews findings from microbiology EQAP surveys in Africa during 2002–2009.
  • Gershy-Damet GM, Rotz P, Cross D, et al. (2010). The World Health Organization African Region Laboratory Accreditation Process: Improving the Quality of Laboratory Systems in the African Region. American Journal of Clinical Pathology, 134(3), 393-400.

    • Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. This article discusses reviews how this pragmatic and effective action to improves patient care, prevention, and disease surveillance.

  • Joloba M, Mwangi C, Alexander H, et al. (2016). Strengthening the Tuberculosis Specimen Referral Network in Uganda: The Role of Public-Private Partnerships. Journal of Infectious Diseases, 213(S2), 41-46.    
    • Diagnosis of multidrug-resistant tuberculosis and prompt initiation of effective treatment rely on access to rapid and reliable drug-susceptibility testing. Efficient specimen transport systems and appropriate training on specimen referral contribute to optimal and timely access to tuberculosis diagnostic services. This study demonstrates the potential of public-private partnership collaborations with ministries of health to positively influence patient care by strengthening laboratory systems through increased access to drug-susceptibility testing in Uganda.
  • Kebede S, Gatabazi JB, Rugimbanya P, et al. (2011). Strengthening systems for communicable disease surveillance: creating a laboratory network in Rwanda. Health Research Policy and Systems, 9(1), 27.     
    • This article reviews the development of Rwanda’s National Reference Laboratory (NRL) to understand the essential structures involved in creating a national public health laboratory network. The authors purposefully sought to identify success factors as well as challenges inherent in developing a national public health laboratory system.
  • Kebede Y, Fonjungo PN, et al. (2016). Improved Specimen-Referral System and Increased Access to Quality Laboratory Services in Ethiopia: The Role of the Public-Private Partnership. Journal of Infectious Diseases, 213(S2), 59-64.    
    • Nonstandardized specimen-transport logistics, lack of laboratory personnel to transport specimens, lack of standard specimen containers, and long turnaround time (TAT) hindered access to quality laboratory services. This study evaluated a public-private partnership (PPP) that sought to support country-specific programs to develop integrated laboratory systems, services, and quality improvement strategies, with an emphasis on strengthening the specimen-referral system. The authors highlight the feasibility and untapped potential of PPPs to strengthen laboratory systems.
  • Kimball AM, Moore M, French HM, et al. (2008). Regional Infectious Disease Surveillance Networks and their Potential to Facilitate the Implementation of the International Health Regulations. Medical Clinics, 92(6), 1459-71.          
    • The International Health Regulations (IHR) 2005 present a challenge and opportunity for global surveillance and control of infectious diseases. This article examines the opportunity for regional networks to address this challenge. Two regional infectious disease surveillance networks, established in the Mekong Basin and the Middle East, are presented as case studies. The public-private partnerships in the networks have led to an upgrade in infectious disease surveillance systems in capacity building, purchasing technology equipment, sharing of information, and development of preparedness plans in combating avian influenza. These regional networks have become an appropriate infrastructure for the implementation of the IHR 2005.
  • Martin R, Barnhart S. (2011). Global Laboratory Systems Development: Needs and Approaches. Infectious Disease Clinics, 25(3), 677-91.             
    • Functional laboratory systems are a key component of country health care systems. Laboratory strengthening in resource-limited countries has been supported by disease-specific vertical programs that have focused on laboratory methods, procedures, and supplies for a country program, and providing training in performing tests. A health systems focus requires attention to regulations, management of national systems, national approaches to quality assurance, and education of laboratory scientists. An immediate focus of resources on the components required for a functioning system and continued technical support will enable countries to assume responsibility for their country-specific needs and improve their capability to address international responsibilities.
  • Masanza MM, Nqobile N, Mukanga D, et al. (2010). Laboratory capacity building for the International Health Regulations (IHR[2005]) in resource-poor countries: the experience of the African Field Epidemiology Network (AFENET). BMC Public Health, 10(S1), 8-14.   
    • Laboratories are one of the core capacities that countries must develop for the implementation of the International Health Regulations (2005), as their services play a major role in all the key processes of detection, assessment, response, notification, and monitoring of events. While developed countries easily adapt their well-organized routine laboratory services, resource-limited countries need considerable capacity building as many gaps still exist. This paper discusses efforts made by the African Field Epidemiology Network (AFENET) in supporting laboratory capacity development in the Africa region. The authors conclude that AFENET’s approach of strengthening national and sub-national systems provide a model that could be adopted in resource-limited settings such as sub-Saharan Africa.
  • Ndihokubwayo JB, Maruta T, Ndlovu N, et al. (2016). Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation. African Journal of Laboratory Medicine, 5(1), 1-8. 
    • The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. This article describes the implementation of the WHO AFRO SLIPTA programme and progress to date in 18 countries.
  • Ned-Sykes R, Johnson C, Ridderhof JC, et al. (2015). Competency guidelines for public health laboratory professionals: CDC and the association of public health laboratories. MMWR Suppl, 64(1), 1-81.
    • These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory professionals to deliver core services efficiently and effectively. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert. These competency guidelines are targeted to scientists working in public health labs, defined as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies. 
  • Nkengasong JN, Mesele T, Orloff S, et al. (2009). Critical Role of Developing National Strategic Plans as a Guide to Strengthen Laboratory Health Systems in Resource-Poor Settings. American Journal of Clinical Pathology, 131(6), 852-57.   
    • Medical laboratory services are an essential, yet often neglected, component of health systems in developing countries. Strengthening these services will require coordinated efforts by national governments and partners and can be achieved by establishing and implementing national laboratory strategic plans and policies that integrate laboratory systems to combat major infectious diseases. This article discusses the need for these plans to take into account policy, legal, and regulatory frameworks; the administrative and technical management structure of the laboratories; human resources and retention strategies; laboratory quality management systems; monitoring and evaluation systems; procurement and maintenance of equipment; and laboratory infrastructure enhancement.
  • Nkengasong JN, Nsubuga P, Nwanyanwu O, et al. (2010). Laboratory Systems and Services Are Critical in Global Health: Time to End the Neglect? American Journal of Clinical Pathology, 134(3), 368-73.    
    • This article discusses the need for approaches to sustainably strengthen national laboratory systems in resource-poor countries. Nkengasong and colleagues discuss approaches including: (1) developing integrative national laboratory strategic plans and policies and building systems to address multiple diseases; (2) establishing public-private partnerships; (3) ensuring effective leadership, commitment, and coordination by host governments of efforts of donors and partners; (4) establishing and/or strengthening centers of excellence and field epidemiology and laboratory training programs to meet short- and medium-term training and retention goals; and (5) establishing affordable, scalable, and effective laboratory accreditation schemes to ensure quality of laboratory tests and bridge the gap between clinicians and laboratory experts on the use of test results.
  • Nsubuga P, Johnson K, Tetteh C, et al. (2011). Field Epidemiology and Laboratory Training Programs in sub-Saharan Africa from 2004 to 2010: need, the process, and prospects. Pan African Medical Journal, 10, 24-36.
    • A competently trained public health workforce that can operate multi-disease surveillance and response systems is necessary to address other public health problems. In Sub-Saharan Africa, the Epidemic Intelligence Service (EIS) program of the US Centers for Disease Control and Prevention (CDC) has been the backbone of public health surveillance and response in the US during its 60 years of existence. EIS has been adapted internationally to create the Field Epidemiology Training Program (FETP) in several countries. This article describes a process used to develop 10 FELTPs covering 15 countries in sub-Saharan Africa from 2004 to 2010 as a strategy to develop a locally trained public health workforce that can operate multi-disease surveillance and response systems.
  • Parsons LM, Somoskovi A, Lee E, et al. (2012) Global health: integrating national laboratory health systems and services in resource-limited settings. African Journal of Laboratory Medicine, 1(1), 1-5. 
    • Laboratory systems worldwide are challenged not only by the need to compete for scarce resources with other sections of national health care programs but also with the lack of understanding of the critical role that laboratories play in the accurate diagnosis and monitoring of patients suffering from high-burdens of disease. An effective approach to establishing cost-effective laboratory systems that provide rapid and accurate test results for optimal impact on patient care is to move away from disease-specific programs and establish integrated laboratory services. As such, this article described various strategies for, and practical examples of, the successful integration of laboratory services.
  • Peeling RW, Mabey D. (2010). Point-of-care tests for diagnosing infections in the developing world. Clinical Microbiology and Infection, 6(8), 1062-69. 
    • Infectious diseases continue to cause an enormous burden of death and disability in developing countries. Increasing access to appropriate treatment for infectious diseases could have a major impact on disease burden. Some common infections can be managed syndromically without the need for diagnostic tests, but this is not appropriate for many infectious diseases, in which a positive diagnostic test is needed before treatment can be given. Since many people in developing countries do not have access to laboratory services, diagnosis depends on the availability of point of care (POC) tests. This review focuses on POC tests for infectious diseases that could be used to improve clinical management in resource-limited settings.
  • Petric M, Comanor L, Petti CA. (2006). Role of the Laboratory in Diagnosis of Influenza during Seasonal Epidemics and Potential Pandemics. Journal of Infectious Diseases, 194(S2), 98-110.   
    • Laboratory diagnosis of influenza is critical to its treatment and surveillance. With the emergence of novel and highly pathogenic avian influenza viruses, the role of the laboratory has been further extended to include isolation and subtyping of the virus to monitor its appearance and facilitate appropriate vaccine development. Recent progress in enhancing testing for influenza promises to both improve the management of patients with influenza and decrease associated health care costs. This review covers the technological characteristics and utilization features of currently available diagnostic tests, the factors that influence the selection of such tests, and the developments that are essential for pandemic preparedness.
  • Petti CA, Polage CR, Quinn TC, et al. (2006). Laboratory Medicine in Africa: A Barrier to Effective Health Care. Clinical Infectious Diseases, 42(3), 377-82.
    • Providing health care in sub-Saharan Africa is a complex problem. Recent reports call for more resources to assist in the prevention and treatment of infectious diseases that affect this population, but policymakers, clinicians, and the public frequently fail to understand that diagnosis is essential to the prevention and treatment of disease. Access to reliable diagnostic testing is severely limited in this region, and misdiagnosis commonly occurs. Understandably, allocation of resources to diagnostic laboratory testing has not been a priority for resource-limited healthcare systems, but unreliable and inaccurate laboratory diagnostic testing leads to unnecessary expenditures in a region already plagued by resource shortages, promotes the perception that laboratory testing is unhelpful, and compromises patient care. This article explores barriers to implementing consistent testing within this region and illustrate the need for a more comprehensive approach to the diagnosis of infectious diseases, with an emphasis on making laboratory testing a higher priority.
  • Shears P. (2000). Emerging and reemerging infections in Africa: the need for improved laboratory services and disease surveillance. Microbes and Infection. 2(5), 289-95.   
    • Emerging and reemerging infections pose a serious public health threat to most countries of tropical Africa. In the past decade, epidemics of diseases including cholera, dysentery, meningitis, yellow fever and Ebola virus have resulted in significant morbidity and mortality. Improved laboratory services and disease surveillance systems are essential to monitor disease trends and to initiate public health action. Shears describes the situation of emerging and reemerging infections in Africa in this review and discusses strategies for improved disease surveillance and monitoring.
  • Taboy CH, Chapman W, et al. (2010). Integrated Disease Investigations and Surveillance planning: a systems approach to strengthening national surveillance and detection of events of public health importance in support of the International Health Regulations. BMC Public Health, 10(S1), S6. 
    • The international community continues to define common strategic themes of actions to improve global partnership and international collaborations in order to protect our populations. The International Health Regulations offer one of these strategic themes whereby World Health Organization Member States and global partners engaged in biosecurity, biosurveillance, and public health can define commonalities and leverage their respective missions and resources to optimize interventions. Capacity building programs have wrestled with ways to improve partner country buy-in and ownership and to develop sustainable solutions that impact integrated disease surveillance outcomes. Designing successful implementation strategies represents a complex and challenging exercise and requires robust and transparent collaboration at the country level. To address this challenge, tools have been developed that bring together key leaders of the surveillance system into a deliberate system design process. The underlying concepts and methodology of these tools are presented here.
  • World Health Organization. (2016). Stepwise implementation of a quality management system for a health laboratory. Cairo: WHO-EMRO.    
    • This document aims to support health laboratories to implement essential elements of quality assurance and quality management according to national health laboratory policies and systems. It presents a minimum set of standards that can be readily adapted and applied to laboratories at every level of the health care system. It can also be used to develop a practical strategy for the preparation and implementation of national guidelines for quality assurance and quality management in health laboratories, on the basis of the quality elements provided by this guidance and after adaptation to meet local and national requirements. The guidance will also support national policy-makers and regulators in developing national quality standards.
  • World Health Organization, Regional Office for Africa. (2015). Guidance for Establishing a National Health Laboratory System. Brazzaville: WHO.

    • This document details and explains the requirements for a laboratory to operate and function. It aims to help countries move away from a disease-specific laboratory focus towards an integrated, coordinated health laboratory system that promotes the efficient use of resources and improved laboratory service delivery, builds country-wide laboratory capacity, and ensures laboratories at all levels of the health system contribute to national disease surveillance and control.

  • World Health Organization. (2015). Laboratory Quality Stepwise Implementation. Geneva: WHO.            
    • This is the Laboratory Quality Stepwise Implementation (LQSI) Tool is an online resource that provides a stepwise plan to guide medical laboratories towards implementing a quality management system. It may help laboratories to fulfil the requirements of the standard to enable achievement of accreditation. It was developed by the Royal Tropical Institute for the WHO and is based on the Global Laboratory Initiative Stepwise Process towards Tuberculosis Laboratory Accreditation (GLI tool).
  • World Health Organization. (2012). Laboratory Assessment Tool. Geneva: WHO.
    • This document offers guidance to assess laboratories and the national laboratory system. It describes a general process for assessing laboratories and provides questionnaires to help to assess the national laboratory system and individual laboratories. The document and its questionnaires can be used as such or after an adaptation to meet local requirements or specificities and better fit the assessment context.
  • World Health Organization. (2011). Development of a National Health Laboratory Policy and Plan. New Dehli: WHO-SEARO.
    • This guidance document provides technical support on the steps required to develop and effectively implement a national laboratory policy and national laboratory strategic plan. The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, opera ng and monitoring the health laboratory services, and promoting better coordination of activities among health programs and institutions.
  • World Health Organization. (2011). Laboratory Quality Standards and their Implementation. New Dehli: WHO-SEARO.
    • Establishing and maintaining Laboratory Quality Standards are essential to generate reliable results to support clinical and public health actions. The Laboratory Quality Standards present a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. This document also outlines mechanisms to implement these Standards. This document will be of help to national policy-makers as well as regulators in developing the national Laboratory Quality Standards. It provides a simple approach to meet the minimum requirements set to meet the ultimate objective to comply with ISO 15189 in a logical and step-by-step manner.
  • World Health Organization. (2010). Guidance for Development of National Laboratory Strategic Plans. Geneva: WHO.      
    • This guidance document meant is meant to assist in the development of a National Laboratory Strategic Plan or the updating of a current plan. As such, it can be used as one of many resources in a national process that involves the participation of all stakeholders. Sections of the document identify global partners/organizations involved in laboratory work that can offer assistance, including valuable collaborations and funding support.
  • World Health Organization. (2009). Laboratory Quality Management System Training Toolkit. Geneva: WHO.
    • Training laboratory managers, senior biologists, and technologists in quality management systems is a step towards obtaining international recognition; it is a step that all countries should take. This training toolkit is intended to provide comprehensive materials that will allow for designing and organizing training workshops for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians.
  • World Health Organization. (2004). Laboratory Biosafety Manual: Third Edition. Geneva: WHO.
    • For more than 20 years, since it was first published in 1983, the Laboratory Biosafety Manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. This edition of the manual was extensively revised and expanded so that it now covers risk assessment and safe use of recombinant DNA technology, and provides guidelines for the commissioning and certification of laboratories. Materials on safety in health-care laboratories, previously published elsewhere by WHO, has also been incorporated.
  • Yager P, Domingo GJ, Gerdes J. (2008). Point-of-Care Diagnostics for Global Health. Ann Rev Biomed Eng, 10, 107-44.
    • Biomedical engineers have traditionally developed technologies in response to the needs of the developed world’s medical community. As a result, the diagnostic systems on which they have worked have met the requirements of well-funded laboratories in highly regulated and quality-assessed environments. However, such approaches do not address the needs of the majority of the world’s people afflicted with infectious diseases, who have, at best, access to poorly resourced healthcare facilities with almost no supporting clinical laboratory infrastructure. A major challenge for the biomedical engineering community is to develop diagnostic tests to meet the needs of these people, the majority of whom are in the developing world. This article reviews the context in which the diagnostics must operate, several of the appropriate diagnostic technologies already in distribution, and some emerging technologies that promise to address this challenge.

 

  • Yang JR, Teng HJ, Liu MT, et al. (2017). Taiwan’s Public Health National Laboratory System: Success in Influenza Diagnosis and Surveillance. Health Security, 15(2), 154-64.   
    • Taiwan’s National Laboratory System is one of the action packages of the Global Health Security Agenda, which was launched by the World Health Organization (WHO) to promote health security as an international priority and to encourage progress toward full implementation of the WHO International Health Regulations (IHR) 2005. The mission of each national laboratory system is to conduct real-time biosurveillance and effective laboratory-based diagnostics, as measured by a nationwide laboratory system able to reliably conduct diagnoses on specimens transported properly to designated laboratories from at least 80% of the regions in the country. This article describes the national laboratory system for public health in Taiwan. Additional information on the national influenza laboratory surveillance network is provided to demonstrate how the national laboratory systems work in practice, including descriptions of long-term seasonal influenza characterization and successful experiences identifying novel H7N9 and H6N1 influenza viruses.