Performance of Advanced Quality One Step ™Malaria (P.F.) for Rapid Diagnosis of Symptomatic Plasmodium Falciparum Infections in Tanzania

Background: The use of rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis by providing parasite-based diagnosis in areas where good quality microscopy cannot be maintained. This study evaluated the diagnostic performance of the commercial Advanced Quality One Step ™ Malaria (p.f.) test compared with light microscopy for the diagnosis of symptomatic Plasmodium falciparum malaria at primary health care level in Tanzania. Methods: Capillary blood samples were collected from 613 febrile patients attending the Kongo primary health facility, Bagamoyo District, Tanzania, from March-June 2014. The blood samples were prepared and examined immediately by microscopy of Giemsa stained thick blood smears and the Advanced Quality One Step ™ Malaria (p.f.) test. Light microscopy was used as Gold standard for the diagnostic performance of the RDT at test. Statistical analysis was performed using Stata version 11. Results: Overall 39.5% (242/613) P. falciparum infections were detected by microscopy compared with 38.8% (238/613) by the RDT. The sensitivity and specificity of the RDT was 95.9% (95% CI 92.5-98.0%) and 98.4% (95% CI 96.5-99.4%) respectively, with corresponding positive and negative predictive values of 97.5% (95% CI 94.6-99.1%) and 97.3% (95% CI 95.2-98.7%) Conclusion: The Advanced Quality One Step™ Malaria (p.f.) test provided a high diagnostic accuracy for detection of symptomatic P. falciparum infections, comparable with gold standard light microscopy. This indicates that the RDT could be considered for the use in primary health care facilities in Tanzania where high quality light microscopy is not available.