Target product profile for readers of rapid diagnostic tests

Overview

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

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

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