Background: A freeze-dried antigen was developed with Leishmania (L.) infantum and used for the production of a prototype direct agglutination test kit for the laboratory diagnosis of visceral leishmaniasis (VL), called DAT-LPC. On this study the diagnosis validity of this prototype was performed. Methods: To evaluate the sensitivity and specificity 103 samples from Brazilian patients with VL and 110 samples from patients with other parasitic infections, and healthy subjects were assayed with DAT-LPC and DAT-KIT (Royal Tropical Institute, Amsterdam, NL). Additionally, the results of 103 samples of VL patients based on two agglutination tests were transformed in Log10 and correlated. Results: The DAT-LPC showed a sensitivity of 99.0%, specificity of 98.2% and diagnosis validity of 98.6%, which were similar to those found by the DAT-KIT (p.0.05). Moreover, there was positive correlation between the positive titers obtained by DAT-LPC and by DAT-KIT (Spearman correlation coefficient of 0.75 p ¼ 0.0001). Conclusions: DAT-LPC showed thermal stability and diagnosis performance similar to those of the DAT-KIT. Our results suggest that DAT-LPC is a robust, simple, equipment-independent and efficient tool for the diagnosis of VL and should thus replace the IFAT as routine diagnostic test in the Brazilian public health system.2100-01-01