OBJECTIVE: To evaluate the diagnostic performance of CareStart Malaria Pf/Pv Combo test relative to microscopy, for the diagnosis of falciparum and vivax malaria in Ethiopia. METHODS: Two hundred and forty febrile patients visiting the Serbo health center in Jimma zone, southwestern Ethiopia, were involved in this study in 2008. Giemsa-stained thin and thick blood smears were prepared and microscopically examined under a 100x oil immersion microscope objective for Plasmodium species identification and determination of parasitemia respectively. CareStart Malaria Pf/Pv Combo test was performed as per the manufacturers' instruction. FINDINGS: The validity of CareStart Malaria Pf/Pv Combo test for the diagnosis of Plasmodium was very good with a sensitivity of 95.8%, specificity of 100%, positive predictive value of 100% and negative predictive value of 96%. The test performed equally well for the identification of Plasmodium falciparum and P. vivax. The diagnostic performance of this CareStart test is comparable to light microscopy of thin and thick blood smears. CONCLUSION: Although CareStart Malaria Pf/Pv Combo test and blood microscopy have comparable diagnostic performance for Plasmodium detection, the CareStart test has the added advantage of being simple to interpret, cost-efficient, and hence it is preferable to use this rapid diagnostic test for malaria diagnosis in areas where microscopy is not accessible and during times of malaria epidemics that are observed approximately every 4-5 years in Ethiopia.