A framework for the assessment and implementation of diagnostics in outbreak situations

OBSERVATION: Outbreak situations require in vitro diagnostics (IVDs) to identify those who are infected and to track the infectious agent in the population. However, such IVDs are typically not available and must be developed. In addition, the process of IVD development, assessment, and implementation are very time and resource intensive. Recognising the extraordinary public health need for IVDs in an outbreak situation, streamlined processes are needed to provide tests that meet the standard of a reasonable assurance of safety and effectiveness in the shortest amount of time. These IVDs are designated for outbreak use. ADDRESSING ISSUES: This paper presents a pathway to the outbreak use of IVDs that can be considered by countries experiencing an outbreak situation. It takes into account recognition of the outbreak, product development, regulatory evaluation, implementation, and monitoring of the outbreak-use test. Streamlined assessment programmes for emergency-use tests have been established by the US Food and Drug Administration and the World Health Organization. These programmes take into account test requirements for the country in which the outbreak exists. Therefore, countries can consider adopting these tests without the need to conduct expensive and time consuming assessments, such as performance studies. Key responsible parties are identified for each step of the pathway, recognising that transparency and communication among all parties are critical.