TB tests have not always been the most accessible to communities as they require sputum production and long laboratory result waits. This sometimes can exclude children, nomadic people, and communities living in remote areas. Novel tests that are based on swabs or urine samples can return a higher rate of diagnosis close to the communities that need them.
However the path to introducing them in country is often complex with obscure processes. We produced reports and flowcharts with timeframes specified by country regulators and actors involved in demand creation and procurement to elucidate end-to-end processes, including which forms and dossiers manufacturers have to submit to national authorities, what type of campaigns will help sensitise communities to new tests, and what are procurement timelines from filing of forms to arrival at the country’s ports.
Working with National TB Programmes, national regulatory authorities, private laboratories, and civil society and community health workers in Ethiopia, Gabon, Kenya, Nigeria, and South Africa – we identified key timelines and processes for test introduction, including that in South Africa, it takes 3-12 months for a regular regulatory review and 90 days or less for an expedited review, that there are two regulatory pathways that can be taken in Nigeria, and that in Kenya, abridged or expedited regulatory pathways take between 4-7 months with WHO prequalification.