WHO Consultation: Target Product Profile (TPP) for readers of rapid diagnostic tests (RDT readers)

The World Health Organization (WHO) with FIND, the global alliance for diagnostics, is seeking feedback on Target Product Profile (TPP) for readers of rapid diagnostic tests (RDT readers).

Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in the management and diagnosis of infectious diseases including malaria, HIV, and COVID-19. Visually interpreted RDTs can be used at the lowest levels of healthcare and in self-testing. Their utility, however, is compromised every time a test is not performed correctly or its result is not available in a timely manner for clinical decision making and surveillance.  

Companion tools for RDTs such as readers could promote more consistent, accurate test performance and reporting. These RDT readers may take the form of dedicated instruments or apps on mobile phones and tablets, whether for professional use or self-testing, and whether as an aid to clinical diagnosis or a non-clinical data capture tool.

Read the draft for consultation here.

Interested parties can provide comments using the following form.

Consultation deadline September 16, 2022.