One Step Diagnostic Rapid Test Castle
Summary
In recent years, a wide range of one-step diagnostic tests castle has become available for use in resource-limited settings. Consequently, a large number of guidelines, performance evaluations, and implementation reports have been produced. However, this vast amount of information is unstructured and of uneven quality, which has made it difficult for end-users such as clinics, laboratories, and ministries of health to determine which test would best improve clinical care and drug outcomes. patients in a specific context.
This document describes a six-step guide for the selection and implementation of in vitro diagnostic tests based on the practical experience of Médecins Sans Frontières: (i) define the purpose of the test; (ii) review the market; (iii) determine regulatory approval; (iv) determine the diagnostic accuracy of the test under ideal conditions; (v) determine the diagnostic accuracy of the test in clinical practice; and (vi) monitor the performance of the test in routine use.
Gaps in the information needed to complete these six steps and gaps in regulatory systems are highlighted. Finally, ways to improve the quality of diagnostic tests are suggested, such as establishing a model list of essential diagnoses, establishing a repository of information on diagnostic study design, and improving quality control and post-marketing surveillance.
