Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.

As companion tools, RDT readers promote more consistent, accurate test performance, interpretation and reporting, as recognized in a revision of the ASSURED criteria3 and in comparisons of manual and automatic reports of positivity.4 Blood Sugar Monitoring System

This target product profile (TPP) addresses various types of RDT reader, with no prioritization:

• a dedicated hardware instrument or an app that operates on a general-purpose mobile device such as a tablet or phone;

• a reader designed for professional use by a health-care worker or other representative of a health programme (such as a disease control programme, a laboratory service of a ministry of health or a private health-care system) or for lay use (i.e., self- and home testing);

• one that acts within the narrow bounds of a non-medical reader, recording the user’s interpretation of the test as the definitive result and transmitting the reader’s interpretation only for non-medical uses such as public health surveillance, monitoring, evaluation and external quality assessment, or one that serves as a medical reader, which provides its interpretation to its user as a basis for diagnosis and treatment as a regulated medical device or in vitro diagnostic; and

Blood Sugar Glucose Monitor • a reader offered by the manufacturer of the RDT or provided independently for use with one or more RDT brands.