CLINICAL EVALUATION OF RAPID DIAGNOSTIC KITS FOR MALARIA INFECTION

Yong-Gyoo Lee, Man Kyu Huh and Yong Lim*

ABSTRACT

Malaria is a mosquito-borne tropical or subtropical disease caused by Plasmodium parasite. Malaria rapid diagnostic tests (RDTs) represent one diagnostic method that is used in a variety of contexts to overcome limitations of other diagnostic techniques. In this study, we evaluated the accuracy and precision of the Malaria RDT kits (G Company, Korea) relative to the manufacturer’s specifications in Korea, and Vietnam. 172 of RDTs were equally sensitive in detecting Plasmodium falciparum. 165 samples were positive and seven samples were negative. Specificity of G kits was 100.0% (172/172) for P. falciparum and its sensitivity was 95.9% with Pf/Pv Ag. RDT specificity was similar for detection of P. vivax. For detecting P. vivax infection, all 205 positive RDTs had similar sensitivity. Sensitivity for P. vivax was 95.9%. Among the 387 RDT negative samples, only five presented LDH band (plus HRP2 band), giving an overall LDH negativity rate of 98.7%. This helps to ensure the accuracy of the diagnosis, and the safety of the health worker and patient.

Keywords: Malaria, Plasmodium falciparum, P. vivax, rapid diagnostic tests (RDTs).