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: 668 febrile patients visiting two health centers in Wondo Genet, southern Ethiopia, 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 parasitaemia, respectively. CareStart Malaria Pf/Pv Combo test and Paracheck Pf test were performed as per the manufacturers' instruction.
Findings: The diagnostic validity of CareStart Malaria Pf/Pv Combo test for the diagnosis of Plasmodium falciparum were very good with sensitivity of 99.4%, specificity of 98%, positive predictive value of 94.4% and negative predictive value of 99.8%. Sensitivity, specificity, positive predictive value and negative predictive value of the test for the diagnosis of P. vivax were 99.4%, 98.2%, 94.5% and 99.8%, respectively. The diagnostic performance of CareStart Malaria Pf/Pv Combo test is comparable to that of Paracheck Pf test for the diagnosis of P. falciparum (sensitivity 99.4%, specificity 98.2%).
Conclusion: Although CareStart Malaria Pf/Pv Combo test and Paracheck Pf test have comparable diagnostic performance for the diagnosis of P. falciparum, CareStart Malaria Pf/Pv Combo test has the added advantage of diagnosing P. vivax. Hence, it is preferable to use CareStart Malaria Pf/Pv Combo test for the diagnosis of malaria in areas where microscopy is not accessible and where malaria due to P. falciparum and P. vivax are co-endemic as in Ethiopia.