Abstract
Background: Due to the difficulty in implementing microscopy-based definitive diagnosis of malaria especially in resource-poor areas, rapid diagnostic test (RDT) kits as alternatives have been developed by different companies. Kits from different companies may differ in sensitivity and specificity. It is therefore imperative to conduct field evaluation of kits from different manufacturers before they are recommended for widespread use in diagnosis of malaria. The present study sought to evaluate the performance of malaria RDT kits from two manufacturers against microscopy in detection of Plasmodium spp. infections among primary school children in Baringo County, Kenya. Methods: Two cross-sectional comparative surveys to assess three RDT kits (CareStart HRP-2, SD Bioline Ag-Pf and SD Bioline Ag-Pf/Pan) were conducted on 561 pupils from three primary schools within the Kerio Valley of Baringo County, Kenya. Results: A total of 561 blood samples were tested for Plasmodium spp. within a period of four months. SD Bioline Ag-Pf/ Pan RDT kit had a higher sensitivity (90%) compared to that of CareStart HRP-2 (70%) but this was not statistically significant (McNemar’s χ2 = 0.5, df = 1, p = 0.4795). The sensitivity of SD Bioline Ag-Pf was the same as that of Care Start HRP-2 (82.4%). The number of positive samples by microscopy was relatively lower than those detected by RDT kits. Two cases of non-P. falciparum infections were detected by RDT kits during the second survey. Conclusion: The results of the present study suggest that the performance of the three kits in the diagnosis of P. falciparum infections was better than microscopy. The sensitivity of SD Bioline Ag-Pf/Pan was slightly greater than that of Care Start HRP-2, although not statistically different.
Highlights
Malaria is a major public health problem accounting for 21% of out-patient consultation and 3% - 5% of hospital admissions in Kenya (KMOH [1] [2])
The results of the present study suggest that the performance of the three kits in the diagnosis of P. falciparum infections was better than microscopy
A total of 261 primary school pupils were tested out of whom 35 (13.4%) tested positive for P. falciparum infections by both rapid diagnostic test (RDT) kits while microscopic analysis showed that 7 (2.7%) of the blood slides were positive for P. falciparum
Summary
Malaria is a major public health problem accounting for 21% of out-patient consultation and 3% - 5% of hospital admissions in Kenya (KMOH [1] [2]). Many treated confirmed cases in Africa are lower compared to other regions of the world [4] This suggests that majority of treated cases are clinically diagnosed yet this type of diagnosis can be unreliable due to the non-specific nature of signs and symptoms of malaria [5]. The present study sought to evaluate the performance of malaria RDT kits from two manufacturers against microscopy in detection of Plasmodium spp. infections among primary school children in Baringo County, Kenya. Methods: Two cross-sectional comparative surveys to assess three RDT kits (CareStart HRP-2, SD Bioline Ag-Pf and SD Bioline Ag-Pf/Pan) were conducted on 561 pupils from three primary schools within the Kerio Valley of Baringo County, Kenya. The sensitivity of SD Bioline Ag-Pf/Pan was slightly greater than that of Care Start HRP-2, not statistically different
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