Bulletin of the World Health Organization

Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings

Grace Wu & Muhammad H Zaman

Volume 90, Number 12, December 2012, 914-920

Table 1. ASSURED characteristics (WHO) and examples of target specifications for the evaluation of point-of-care devices

Characteristic Target specification
Affordable Less than US$ 500 per machine, less than US$ 10 per test
Sensitivity, specificity Lower limit of detection: 500 HIV RNA copies per mL, 350 CD4+ T-cells per μL
User-friendly 1–2 days of training, easy to use
Rapid and robust < 30 minutes for diagnosis, < 1.5 hours for HIV load monitoring, minimal consumables (i.e. pipettes), shelf life > 1 year at room temperature, high throughput
Equipment-free Compact, battery powered, on-site data analysis, easy disposal, easy sample handling, no cold chain
Deliverable Portable, hand-held

ASSURED, affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end users; HIV, human immunodeficiency virus; RNA, ribonucleic acid; US$, United States dollars; WHO, World Health Organization.