TPP: For readers of rapid diagnostic tests

As companion tools, RDT readers promote more consistent, accurate test performance, interpretation and reporting.

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

Minimal: Non-medical: To collect user interpretations and other data from RDTs. Medical: To interpret RDTs to aid clinical decisions and to collect other data from RDTs

Optimal: Same as minimal plus to support proper test performance

(A non-medical reader does not show its interpretation to the user. For medical readers, in most countries each combination of reader and test is subject to medical regulation.)

The reader may be used in screening, diagnosis or management of disease. The reader transmits test data, patient data entered by the user and contextual data to the health programme.

Professional use: Health-care worker, including community health worker, with at least basic literacy and minimal training or any health-care worker with additional training

Lay use: Person with at least basic literacy but no formal education in a relevant field of health care or medical discipline

App: Person with access to a mobile device and basic app skills

The operator may have requirements for access that must be met by the reader.

Minimal: Instrument or app operates with one test at a time.

Optimal: Instrument: Offered in two or more configurations. App: Interprets one test at a time, and can guide administration of multiple tests in parallel, tracking the timing of each

All levels of health care as well as non-health-care settings

Data features within the reader (see url for full details)

Diagnostic data collected

Patient/case data collected

Contextual data collected