Evaluation of malaria rapid diagnostic tests among children in a malaria endemic region in coastal Kenya

George O. Osanjo, Irene A Onyango, Josephine Kimani, James Ochanda, Julius Oyugi


Background: In Kenya, malaria case management is based on clinical suspicion and detection of parasite in blood by parasitological or confirmatory diagnosis. Confirmatory diagnosis can be achieved with either microscopy or Rapid diagnostic tests (RDTs). RDTs are relatively new technologies, and their performance in actual conditions of use needs to be evaluated to provide information for appropriate use and to support decision making in procurement.

Objectives: To evaluate performance and operational characteristics of three malaria RDTs: CareStart™, First Response®, and SD Bioline™ in the field for diagnosis of infection by Plasmodium falciparum monospecies as well as mixed infections with P. ovale and P. malariae.

Methodology: A prospective study with blind comparisons to a gold standard was carried out at Pingilikani dispensary in Kilifi County, Kenya. Blood samples were obtained from 500 febrile children. Three RDTs: CareStart™, First Response® and SD Bioline™ were evaluated against microscopy of Giemsa stained blood films for detection of Plasmodium falciparum and non-falciparum malarial parasites. RDTs specific for P. falciparum only (HRP2 RDTs) and non-falciparum malarial parasites (HRP2/pLDH (Pf/pan) RDTs) were evaluated.

Results: Plasmodium sp were detected by microscopy in 242 (48.40%) study participants. Plasmodium falciparum species were the most prevalent (93.3%) in comparison with other Plasmodium species: P. ovale and P. malariae whose prevalence were 2.89% and 3.71% respectively. Compared to microscopy the sensitivities of CareStart™, SD Bioline™, and First Response® RDTs for Plasmodium falciparum using Pf (mono species) kits were: 95.04% (95% CI: 92.34 - 97.73), 95.04% (95% CI: 92.34 - 97.73) and 94.21% (95% CI: 91.3 - 97.11) respectively while the specificities were 78.12% (95% CI: 72.98 - 83.25), 81.10% (95% CI: 76.23 - 85.96) and 78.74%  (95% CI: 73.65 - 83.82) respectively. Sensitivities of CareStart™, SD Bioline™ and First Response® RDTs for Plasmodium falciparum using Pf/Pan kits were: 99.02% (95% CI: 98.92 - 99.15), 99.04% (95% CI: 98.92 – 99.15) and 97.56% (95% CI: 97.78 – 97.99), respectively while the specificities were 78.46% (95% CI: 77.61 - 79.30), 78.46% (95% CI: 75.78 - 81.13) and 80.28% (95% CI: 76.73 - 83.82) respectively. CareStart™, SD Bioline™, and First Response® RDTs for non-falciparum sp using Pf/Pan kits both had 100% sensitivity and specificity.

Conclusion: Data from this study demonstrate that CareStart™, SD Bioline™ and First Response® RDTs have good operational characteristics and are reliable alternatives to microscopy for diagnosing malaria in children.

Key words: malaria, rapid diagnostic tests, microscopy, Plasmodium


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