Detection of Malaria Parasite Protein in Urine of Patients with Acute Uncomplicated Malaria Using Rapid Diagnostic Test Kits

Abstract

Objectives: The invasive nature of the current malaria diagnostic techniques impairs compliance to diagnosis, especially for on-field detection. Adapting non-invasive methods of biological sample collection for rapid diagnosis of malaria infections may provide a more efficient approach to case management and epidemiological studies of malaria. This study was designed to evaluate the detection of Plasmodium falciparum Histidine-rich Protein II (PfHRP-2) in urine samples and optimization as diagnostic markers for P. falciparum infection. 
 Methods: One hundred (100) microscopically confirmed patients with Plasmodium falciparum infection and 25 P. falciparum negative controls were recruited for the study. Blood samples of all participants were tested for the presence of PfHRP-2 using Rapid Diagnostic Test (RDT) kits. In addition, urine samples of the confirmed malaria-infected patients were analyzed for PfHRP-2 using the CareStartTM and Global Devices (USA) Malaria kits. The diagnostic performances of the RDT kits were evaluated.
 Results: Overall, the two brands of malaria rapid diagnostics demonstrated 71% sensitivity (95%CI=62.1-79.9%) and 96% specificity (95%CI=88.3-103.7%) for PfHRP-2 detection in urine. 
 The sensitivities of the tests in urine at asexual parasitemia ≤ 2000 μL-1 and asexual parasitemia > 2000 μL-1 were 69.6% (95%CI=56.3-82.9%) and 72.2% (95%CI=60.3-84.2%) respectively. Global Devices and CareStartTM kits had individual sensitivities of 80% (95%CI= 65.7-94.3%) and 67.1% (95%CI= 56.1-78.1%) respectively for PfHRP-2 detection in urine (P= 0.072).
 Conclusion: Findings revealed that urine-based RDTs have limited capacities for malaria diagnosis due to their low sensitivity and require more optimizations to meet required diagnostic standards. J Microbiol Infect Dis 2022; 12(3):97-107.