Perspectives on introduction and implementation of new point-of-care diagnostic tests

Abstract

In recent years, there has been significant investment from both the private and public sectors in the development of diagnostic technologies to meet the need for human immunodeficiency virus (HIV) and tuberculosis testing in low-resource settings. Future investments should ensure that the most appropriate technologies are adopted in settings where they will have a sustainable impact. Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct. Here, we discuss these considerations from different perspectives representing those of various stakeholders involved in the development, introduction, and implementation of diagnostic tests. We also discuss some opportunities to address these considerations.

Figure 1.

Historical perspective on diagnostic tests for malaria (A), tuberculosis (B) and human immunodeficiency virus (HIV; C) in the context of first recorded observations of disease, identification of pathogen, and approval from the US Food and Drug Administration. Abbreviations: EIA, enzyme immunoassay; ICT, immunochromatography test; NAT, nucleic acid-based test.

Figure 2.

The opportunity for devices at the point-of-care to interface and extend the laboratory information management systems. Connectivity allows real-time and automated data and information exchange to different end users. Abbreviations: EQA, external quality assessment; ID, identification; QA, quality assurance.