Expanding the malaria molecular diagnostic options: opportunities and challenges for loop-mediated isothermal amplification tests for malaria control and elimination.

INTRODUCTION: The loop-mediated isothermal amplification (LAMP) technique holds substantial promise as an alternative easy-to-use molecular test for malaria parasite detection. Several modifications to the initial malaria LAMP assay have been made in an effort to make the LAMP platform more field-friendly. Areas covered: A PubMed literature search was performed using the following search terms: 'malaria,' 'loop mediated isothermal amplification', 'LAMP', 'molecular tests' and 'diagnostics'. The authors review the currently reported malaria LAMP assays and discuss what requirements would be needed to make malaria LAMP assays field-usable, especially in the context of malaria elimination. Expert commentary: Expanding the malaria LAMP tests as options for use in malaria control programs will require addressing some important challenges such as the need for simplified sample preparation steps; ready to use kits that require no cold chain; the use of a non-subjective results readout and preferably cost-effectiveness. Two malaria LAMP kits are now CE-marked and commercially available: the Loopamp MALARIA kit and the Illumigene malaria LAMP. Malaria LAMP tests, like other molecular tests, will likely be utilized in very specific studies such as: to evaluate 'detect and treat' strategies; in controlled malaria infection trials or drug efficacy trials and as confirmatory test in reference laboratories.