Reaching targets for disease control and elimination requires new, easy-to-use diagnostic tools that provide rapid results and – just as importantly – comprehensive approaches to maximize their health impact. In addition to strong political commitment and coordination to translate plans into action, robust laboratory and health systems are essential to fully capture the benefits of new diagnostic tests. FIND supports the implementation of new diagnostics for numerous diseases, including TB, malaria, sleeping sickness, HIV and, most recently, Ebola.
FIND has made a strategic commitment to support countries by:
- Building strong networks of high-quality testing sites, equipped with the right tools and trained staff;
- Engaging all care providers in diagnostic service delivery; and
- Ensuring systems are in place to quickly and effectively link diagnosed patients to care and treatment.
Approach: ensuring impact of diagnostic tools
Diagnostic tests are an integral part of many public health interventions, guiding the detection of disease and the delivery of appropriate therapy, monitoring treatment, and often reducing inappropriate treatment and drug wastage.
The development of point-of-care diagnostics with the capacity for remote communication – otherwise known as diagnostic connectivity – provides an opportunity to collect and analyse data to aid decision-making, for example, to support health ministry resource allocation, disease programme management design, procurement and supply chain forecasting and plans, and disease surveillance.
FIND supports countries to adopt connected diagnostics technologies and to build the capacity to make better use of collected data to improve decisions and health systems.
TB diagnostic network mapping
Limited resources and distance from diagnostic services often act as barriers to patients accessing a TB diagnosis or remaining on the diagnosis-to-treatment pathway.
FIND is working with countries to assess their existing TB diagnostic networks and to develop optimization strategies to increase access to rapid TB diagnostics and linkages to treatment and care.
Xpert MTB/RIF implementation support
FIND supports countries to implement the GeneXpert MTB/RIF test, a WHO-approved TB test that can also diagnose some multidrug-resistant TB. This work includes conducting research and analysis to guide TB diagnostic policy, national planning and use of new tools, as well as the development of technical guidance and job aids, and the delivery of training.
Diagnosis of paediatric TB pilot project
India has the highest global burden of childhood TB, which is particularly difficult to diagnose.
In 2014, FIND ran a pilot project using Xpert MTB/RIF exclusively for children and infants. Through this project, four high-throughput Xpert labs were established. These labs provided same-day diagnosis, free of charge, and all patients were linked to treatment. To facilitate participation and speed up the turn-around time for results, patients presenting at a health centre rather than a lab had their samples picked up and delivered. Results were communicated via SMS or email.
The pilot targeted approximately 10,000 children and achieved a doubling in TB case detection over baseline. The project is currently being scaled up.
Development of tools & trainings
The use of Xpert MTB/RIF requires technical support for laboratory staff, clinicians, programme personnel and others who use the test and/or the resulting data. To facilitate effective uptake, FIND and partners have developed customized training materials, practical tools, and job aids to support deployment of the new diagnostic technology.
Alongside this, FIND trains country staff, conducts proficiency testing and programme evaluations, and mentors and supports local programme coordinators, in-country trainers and advanced users.
To access the freely-available implementation tools that FIND has developed, including an Xpert workplan template, Xpert checklists, the Xpert GLI training package and online tests for healthcare workers, visit our page on implementation tools.
Supporting development of national plans
It is critical that new diagnostics implementation plans are rooted within the context of national laboratory and disease-specific strategic plans. FIND assists countries to develop implementation plans to integrate new tools and approaches into their existing laboratory networks based on WHO and other international guidelines and best practices.
In countries such as Haiti, Lesotho, Tanzania and Vietnam, FIND is:
- Providing guidance and advice to Ministries of Health (MOH) in developing evidence-based implementation plans for new TB diagnostics, in alignment with national laboratory and disease-specific strategic plans;
- Assisting in the development of national diagnostic algorithms based on WHO recommendations;
- Conducting and mentoring personnel in the analysis of epidemiological data to inform algorithm and phased roll-out plans;
- Working with local and international implementing and funding partners to achieve a harmonized approach in support of national laboratory strategies; and
- Assessing the readiness of laboratories for new diagnostics implementation.
- Diagnosis of paediatric TB pilot project
Laboratory strengthening towards accreditation
Implementing and integrating new diagnostic technologies can only be successful in a well-functioning laboratory system. FIND recognizes that laboratory services in resource-limited settings face many challenges. To address this need, FIND’s delivery programme has been guiding countries in strengthening laboratory capacity.
To access related resources, please visit our Implementation tools & resources page.
Working towards laboratory accreditation is a challenging process requiring long-term commitment and support. SLMTA is a task-based training and mentoring tool kit, developed by CDC, WHO-AFRO and partners (ASCP and CHAI), that aims to empower laboratory personnel to implement International Organization of Standards (ISO) requirements and move towards accreditation readiness in a stepwise manner.
The SLMTA programme is a structured programme that incorporates training workshops, improvement projects and follow-up visits. SLMTA is a training programme to accompany the Strengthening Laboratory Improvement Process Towards Accreditation (SLIPTA) certification, which is used to measure and evaluate the progress of laboratory quality systems. Certificates of recognition are given to laboratories, and a 1-5 star scoring system indicates the level of accreditation readiness.
The SLMTA training curriculum is taught at two levels: at the training-of-trainers level and at in-country implementation level. At country level, the 50-plus hours of learning is usually taught over a series of three workshops, over a 12-18 month period. This task-based curriculum has been implemented successfully in 36 countries in Africa (18), South-East Asia (2), the Caribbean (15), and South America (1).
FIND, in collaboration with CDC Dominican Republic, introduced SLMTA to the Dominican Republic in 2011, and is currently implementing the programme (FOGELA, in Spanish) in 20 laboratories, as well as providing training to other countries in the region.
FIND has developed a TB Stepwise Laboratory Management Towards Accreditation (TB SLMTA) Training Programme. This is a modified version of the SLMTA programme, developed by CDC and partners, and includes TB-specific modules and guidance (safety, sputum collection and transport) with TB-specific activities, examples and tools, based on the successful SLMTA format and interactive, task-based teaching approach.
FIND has also developed a TB Laboratory Quality Management Towards Accreditation Harmonised Checklist, which incorporates the Global Laboratory Initiative (GLI) Stepwise Process Towards TB Laboratory Accreditation checklist components into the WHO Africa Office Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist, allowing integration with general laboratory quality improvement initiatives that are ongoing in many countries.
To date, three TB SLMTA regional training-of-trainer workshops have been held (Lesotho, Vietnam, South Africa), with 62 participants from 19 countries. Of these, 51 have graduated as trainers. Roll-out of the TB SLMTA programme has already been initiated in 35 laboratories in 7 countries. The first countries to implement have already shown measurable improvement between the baseline assessment score and follow-on audits.
Quality assurance (QA) comprises many activities and processes to ensure the quality of diagnostic test results. This includes the use of quality controls, routine data collection, and monitoring and evaluating trends in performance indicators, as well as external quality assurance (EQA).
In many settings, despite well-established international guidelines, laboratory QA is poorly and inconsistently implemented. Challenges include organization of laboratory site visits and feedback of recommendations to laboratories, as well as the data management associated with these tasks.
FIND supports countries to develop and roll out QA programmes through the distribution of EQA samples, introducing field-tested best practices in quality assurance, and developing tools and providing training and support for implementation of data management solutions. FIND uses innovative implementation models, simple field-tested guidance and electronic data management systems to improve implementation of QA programmes.
As part of the global scale-up of HIV testing and treatment, rapid diagnostic tests have become the cornerstone for the diagnosis of HIV. Many of these tests are now performed by lay health workers outside traditional laboratory settings. However, despite their relative simplicity, HIV misdiagnoses still occur due to human errors such as transcription mistakes, logistical challenges such as test kit storage and transportation conditions, and systemic challenges such as inadequate training and supervision.
FIND is working with the U.S. Centers for Disease Control and Prevention (CDC) and local implementing partners in Ethiopia, Kenya, Uganda and Zambia as part of the HIV Rapid Test Quality Improvement Initiative to improve the quality of HIV rapid testing by:
- Supporting changes in national policies related to rapid HIV testing and quality assurance;
- Introducing the use of dried tube specimens to test the proficiency of those who conduct rapid tests;
- Using standardized logbooks or registers for recording test results and following up on associated corrective actions;
- Providing a comprehensive training programme on the proper use of rapid HIV tests with certification of both testing sites and individual testers; and
- Post-market surveillance.
Recognizing the workload of the service providers, this initiative introduces the concept of Quality Corps Volunteers or the “Q-Corps” to support the existing human resources in completing the quality assurance cycle by providing feedback to sites and supporting them to implement corrective actions. FIND is currently working with the CDC to expand these activities in Central Asia and Mozambique.
FIND supports countries in the development of TB quality assurance (QA) guidelines. FIND has also developed a QA manual and is working on proficiency testing for Xpert MTB/RIF in partnership with the U.S. Centers for Disease Control (CDC).
Proficiency testing (PT) is one of the key components of a quality assurance scheme. Currently there is no international PT scheme for Xpert MTB/RIF. Based on CDC’s expertise and experience in developing dried blood spots for rapid HIV proficiency testing, the TB team of the International Laboratory Branch at CDC Atlanta, headed by Dr Heather Alexander, is taking the lead in developing and distributing an Xpert MTB/RIF PT panel. FIND is working to support piloting of this programme in a number of countries, including Lesotho, Tanzania and Vietnam. In addition, FIND is working with partners, including CDC, to evaluate other alternatives for Xpert MTB/RIF PT, and more information on these activities is provided in the South Africa country report.
Quality assurance tools
FIND has developed and is implementing standardized data collection tools for routine monitoring of Xpert indicators, and standardized checklists for on-site monitoring. Work continuing to develop and field test guidelines and tools to improve routine Xpert quality assurance at country level. The most critical factor is finding innovative ways to ensure prompt and relevant feedback and assistance to laboratories to enable them to implement corrective measures.
In collaboration with the World Health Organization (WHO), FIND has established a comprehensive quality assurance scheme for malaria rapid diagnostic tests (RDTs). This programme includes lot testing, product testing and quality control at the point of care. Detailed information on the programme and links to key resources can be found on the WHO-FIND quality assurance of malaria RDTs page.