[Comparison of Rapid Diagnostic Tests for the Detection of Plasmodium vivax Malaria]

Malaria is an acute febrile disease caused by infections transmitted by mosquitoes. Among the five types of malaria parasites capable of infecting humans, Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae, and Plasmodium knowlesi, there were 263 million cases of malaria reported in 83 countries worldwide in 2023. In Republic of Korea, only P. vivax is prevalent, occurring in parts of Incheon, Gyeonggi, Gangwon, and Seoul, which are adjacent to North Korea. Diagnostic methods for confirming malaria include microscopic and polymerase chain reaction (PCR). Presumptive diagnostic methods include rapid diagnostic tests (RDTs), which are recommended for early diagnosis of malaria because they can be used in the field without restrictions. In this study, among the malaria RDTs approved by the Ministry of Food and Drug Safety, sensitivity and specificity were measured for four Pf/Pan kits that can detect all five types of malaria.

Positive samples confirmed by nested PCR were used to calculate the rate of parasitemia based on the cycle threshold value of real-time PCR.

The comparative test results of the kits showed that the sensitivity of each kit ranged from 70.9% to 96.5%, and in particular, samples with a low rate of parasitemia had differences in sensitivity from 43.8% to 93.8%. However, specificity was confirmed to be 100.0% for all kits.

The results of this study provide the information necessary for product selection by identifying differences in the effectiveness of RDTs used for the presumptive diagnosis of malaria.