Abstract
OBJECTIVE: To evaluate the clinical sensitivity and specificity of the newly developed Genedia malaria antigen enzyme-linked immunosorbent assay (ELISA) test and to evaluate the diagnostic efficiency of the combined use of the Genedia malaria antigen and antibody ELISA tests to detect Plasmodium vivax in blood samples. MATERIALS AND METHODS: In all, 1,070 samples were analyzed: 300 P. vivax-infected patients, 41 samples from posttreatment patients upon follow-up and 729 healthy volunteers. The Genedia malaria antigen ELISA test and the Genedia malaria antibody ELISA 2.0 test were evaluated and compared to polymerase chain reaction and microscopy. RESULTS: The Genedia malaria antigen ELISA test had a clinical sensitivity of 94.7% (284/300) and a clinical specificity of 99.3% (724/729). The Genedia malaria antibody ELISA 2.0 test had a clinical sensitivity of 94.0% (282/300) and a clinical specificity of 98.4% (717/729). The Genedia malaria antigen ELISA test was able to detect 13 confirmed P. vivax cases without antibodies against P. vivax, whereas the Genedia malaria antibody ELISA 2.0 test detected 11 confirmed P. vivax cases nonreactive to the Genedia malaria antigen ELISA test, and 25 cases from 41 follow-up samples nonreactive in the Genedia malaria antigen ELISA test. The combined Genedia malaria antigen and antibody ELISA 2.0 tests had a clinical sensitivity of 98.3% (295/300) and a clinical specificity of 97.9% (714/729). CONCLUSION: The combination of antigen and antibody ELISAs improved the diagnostic sensitivity in P. vivax-confirmed cases in the Republic of Korea.