Malaria rapid diagnostic devices (MRDD) have been developed with the hope that they would offer accurate, reliable, rapid, cheap and easily available alternatives to traditional methods of malaria diagnosis. The results from early malaria rapid diagnostic studies were quite promising, especially for detecting Plasmodium falciparum at densities of more than 100-500 parasites/microl. Despite the introduction of these devices over a decade ago, only a few target antigens have been introduced. Of greater concern, these devices have shown limitations in sensitivity, ability to differentiate species and robustness under field conditions in the tropics. Recent trials have revealed wide variability in sensitivity both within and between products. We review the recent trials assessing MRDD use for the diagnosis of P. falciparum and non-P. falciparum infections in endemic and non-endemic countries and describe the various aspects of these devices which need further improvement. High quality, accurate, rapid and affordable diagnostic tools are urgently needed now that new antimalarial regimens, characterized by higher cost and increased toxicity, have been introduced more widely in response to emerging multi-drug resistance.