ABSTRACT
Gross inequities in health standards continue to exist between the developed and developing countries and ensuring access to affordable diagnostics can bridge the equity gap. However, and despite enormous progress in the prevention, diagnosis, and treatment of diseases, developing countries often remain excluded from the benefits of innovations. In countries that do regulate medical devices, the regulatory landscape is highly variable and continuously changing, resulting in greater challenges associated with transparency, language barriers, and costs. In particular, access to rapid, point-of-care diagnostic tests is fundamental in emergency preparedness, in ensuring health system efficiency and, ultimately, for achieving health equity. A suspected dengue fever outbreak in Nicaragua, after rapid diagnosis, is to be leptospirosis instead with important repercussions and implications for the needed public health measures. Laboratory methods to detect HIV infection have been used, but individuals need to take the initiative to present at a clinic for testing. The specificity of the over-the-counter OraQuick test exceeded the minimum recommended performance.
