In a review article by Petti et al. in 2006, the authors described laboratory medicine as a barrier to effective healthcare, with misdiagnosis occurring often.
Since 2008, there have been several landmark events to advance laboratory diagnostics in Africa:
2008: January – the Maputo Declaration for strengthening laboratory health systems;
July 2009: Several African countries, donors, WHO and implementing partners met in Kigali, Rwanda, to launch the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), the WHO AFRO accreditation scheme to assist laboratories in obtaining internationally-recognised accreditation standards
2010: The Kampala Statement called for the creation of the African Society for Laboratory Medicine;
2011: Launch of the African Society for Laboratory Medicine as a pan-African professional body working to advocate for the critical role and needs of laboratory medicine and networks throughout Africa. The African Society for Laboratory Medicine addresses these challenges by working collaboratively with governments, local and international organisations, implementing partners, and the private sector to achieve the following goals by 2020:
Strengthening laboratory workforce by training and certifying laboratory professionals and clinicians through standardised frameworks; Transforming laboratory testing quality by enrolling laboratories in quality improvement programmes to achieve accreditation by international standards; Developing strong, harmonised regulatory systems for diagnostic products as defined by the Global Harmonization Taskforce; and Building a network of national public health reference laboratories to improve early disease detection and collaborative research.
2015: WHO/US Centers for Disease Control and Prevention point-of-care (POC) handbook;
2016: 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. 159 laboratories were audited between May 2013 and March 2015, with a 69% mean score. Of those audited, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%.
Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) inspection checklist score corresponds to the number of stars awarded to a laboratory.
This progress is very encouraging, but there are new challenges with the introduction of POC testing:
POC testing is performed and results interpreted by non-lab personnel with no expertise or experience in doing any form of testing;
POC devices and cartridges are transported all over the country without temperature control;
POC devices and cartridges stored at remote sites often have no temperature control. The devices may be dusty or exposed to extreme humidity. All of these affect the test validity;
Many POC tests lack ‘on-board’ controls, meaning that there is no quality control for the testing process;
Central or national laboratories often do not have sufficient capacity to supervise all POC testing or institute external quality assessment (EQA) programmes for every POC site.
In consultation with the Ministry of Health and representatives from 10 countries with an interest in external quality assurance, the London School of Hygiene and Tropical Medicine, through funding from UNITAID, worked with partners and quality assurance experts to develop strategies and initiatives to support countries in scaling up quality POC testing. Countries shared lessons learned and possible planning for quality POC testing.
While POC has the potential to provide faster results for quicker clinical decisions, a major concern with decentralising diagnostics and laboratory services is the lack of oversight and ensuring quality standards. From the consultations, several models were captured for organising POC testing in Africa (
Quality assurance models for point-of-care testing integrated within existing laboratory networks.
These consultations found a large need for quality assurance planning and policies, especially around POC testing.
This set the stage for our EQA work, as we found that most countries were enrolled in some sort of EQA programme and were also supporting quality assurance activities. Countries shared lessons and tools and identified major gaps in their quality assurance programmes.
These brought together EQA providers as a think tank for global proficiency testing schemes, EQA programmes, and capacity building.
This piloted full coverage of EQA for CD4 POC in one country, which helped the country map the POC landscape and identify gaps and challenges (e.g. broken instruments, supply chain management issues).
This programme explored how to monitor quality assurance of POC testing. It identified numerous gaps as well as promising opportunities with connectivity and automated EQA reporting.
Countries shared costing information and were trained by modellers and economists to perform costing exercises. This information has formed the basis for costing quality assurance as a percentage of the total cost of a POC test. This information can be used for advocacy and budget planning, as well as business plan development.
A series of technical workshops to provide global coverage for HIV CD4, EID, and viral load external quality assurance, including proficiency testing schemes, and to transition EQA programmes to the continent through technology transfer trainings and capacity-building discussions. These workshops will also support regional EQA centres and south-to-south collaborations.
Diagnostics have become central to patient management and disease surveillance/control in the developing world. As laboratory testing is pushed to more remote areas, ensuring accurate diagnostic results as well as sustainable laboratory services becomes a greater challenge to systems that are already struggling.
The London School of Hygiene & Tropical Medicine is working to continue the advancement of laboratory diagnostics in Africa, working with African countries and partners with an interest in EQA to support quality POC testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene and Tropical Medicine has gathered lessons learned, tools and resources, and developed quality assurance models that will support POC testing.
It is important to consider the role of diagnostics and the critical need for quality diagnostics services in the more remote resource-limited settings. Clinicians and patients will increasingly depend on POC testing for improved health outcomes. At the same time, these new diagnostics should be seen as opportunities to improve the health of the community with surveillance and disease control programmes.