Martin-Ramirez, AlexandraLanza-Suarez, MartaHisam, ShamilahPérez-Ayala, AnaRubio Muñoz, Jose Miguel2022-11-152022-11-152022-04-25BMC Res Notes. 2022 Apr 25;15(1):147.http://hdl.handle.net/20.500.12105/15135Objetive: Main malaria diagnosis is based on microscopic examination combined with rapid diagnostic tests. Both methods have low sensitivity and specificity. Loop-mediated isothermal amplification techniques have shown a sensitivity similar to PCR but with lower times of performance. This study aimed to assess a commercial LAMP for the diagnosis of malaria (Alethia® Malaria) against the Nested-Multiplex-Malaria PCR, including the analytical sensitivity and the operational characteristics. Results: One hundred five samples out of 114 rendered valid results, obtaining 85 positive samples and 18 negative samples with an agreement of 98% compared to the reference method with a sensitivity, specificity and kappa coefficient of 98.84%, 94.74% and 0.94 respectively, with only two discrepant samples. The turnaround time was estimated in 1 h and 30 min, with a cost of 32.67€ per determination. The results showed several advantages of the Alethia® Malaria, as it was easy to perform, minimal training requirement and 40 min run. Moreover, it includes an internal control to avoid false negatives. However, it also showed some limitations such as the need for a specific amplification and detection device, the detection of only Plasmodium spp. and a very high price.engVoRhttp://creativecommons.org/licenses/by-nc-nd/4.0/PlasmodiumMolecular diagnosisPlasmodium knowlesiLAMPIllumigene® MalariaAlethia®MalariaPCRMalariaPlasmodium knowlesiHumansMolecular Diagnostic TechniquesMultiplex Polymerase Chain ReactionNucleic Acid Amplification TechniquesSpainAttribution-NonCommercial-NoDerivatives 4.0 Internacional3546883315114710.1186/s13104-022-06037-91756-0500BMC research notesopen access