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 c...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.展开更多
文摘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.
