Introducing RDT-Based Malaria Diagnosis Into National Programmes
Most national programmes have relied heavily on clinical (symptom-based) diagnosis in the past, with microscopy used in larger clinics. As parasite-based diagnosis is introduced at smaller clinics and village level for case management, a large number of challenges arise in logistical management, and in managing the health-seeking and health-providing behaviour of patients and health workers.
Many health workers and communities will have been taught that "fever equals malaria unless proven otherwise". Introducing RDTs will demonstrate that this is not the case. To have an impact on anti-malarial diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients alike, as good or better than that relied on previously. A health worker will also need a good alternative to anti-malarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place (detailed elsewhere on this website). There must be good education of health workers, and widespread community sensitization. Knowledge of other causes of fever will be necessary to develop appropriate management algorithms for parasite-negative cases.
At the national level, regulatory requirements may need to be developed to control the importation and use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, may need to be developed. If changing from a different product or mode of diagnosis, an adequate phase-out plan for this must also be developed.
This requires a clear strategic plan to be developed well in advance of RDT introduction, with a clear timeline to ensure that the various components of the RDT programme are in place at the right time. A focal person, or persons, will be needed to coordinate the overall implementation plan and ensure that the various agencies that may be involved understand the process and their particular roles. To achieve this, funding for the programme must include a significant component for planning and coordination, sensitization/IEC, training, quality assurance, monitoring and supervision, and logistics, in addition to procurement. Without this, much of the funds expended on RDTs may be wasted, and a loss of confidence in RDT-based diagnosis may hinder the process of strengthening appropriate malaria case management.
An example of a national implementation plan is shown below. This will need to be modified considerably for any particular programme, preferably through a collaborative process involving all the major agencies involved in its implementation. Budgeting for all the components of the programme at the outset is vital. An example of components to be considered in an overall budget is shown in the figure attached. Details and examples of various components of the plan can be found elsewhere on this website.
Summary of introduction plan
Program planning and management
- Identify key stakeholders, and secure commitment for introduction of RDTs
- Establish working group and develop terms of reference
- Identify specific focal person(s) responsible for day to day oversight of the implementation plan
Develop a timeline, scope, and budget for implementation
- Identify human and other resource needs, and a strategy for accessing them
- Review and update, if needed, case-management algorithms for malaria and other causes of febrile illness
Policy and regulatory issues
- Develop appropriate regulatory documents if required
- Register RDT products
Procurement of RDTs
- Develop product specifications and packaging requirements
- Develop product short-list
- Conduct quantification (estimation of needs)
- Procure RDTs
- Procure sharps boxes, gloves etc.
Sample Timeline for Introduction of Malaria RDTs
Malaria RDT Implementation Budget
Example of major components of a programme budget to be considered when introducing RDTs into a malaria programme. Without adequate provision for each of these components, it is likely that an RDT-based diagnostics programme will fail to achieve its goals.