The need for regulation and standardisation of in vitro diagnostic (IVD) assays for the diagnosis of acute tropical infections: dengue as a case study

Abstract

A recent review of diagnostics for the developing world stated that the characteristics of the ideal diagnostic test were: ? Affordable by those at risk of infection. ? Sensitive (few false-negatives). ? Specific (few false-positives). ? User-friendly (simple to perform and requiring minimal training). ? Rapid (to enable treatment at first visit) and robust (does not require refrigerated storage). ? Equipment-free. ? Delivered to those who need it. The need for such tests has lead to the development of rapid in vitro diagnostic (IVD) assays for tropical infections such as dengue, tuberculosis, leptospirosis, melioidosis and malaria, with many based on immunochromatographic test (ICT) principles.