Assessing the Performance Characteristics of the “CareStartTM Malaria HRP2 pf (CAT NO: G0141, ACCESSBIO)” Rapid Diagnostic Test for Asymptomatic Malaria in Mutengene, Cameroon

Aim: The aim of this study was to determine the prevalence and density of malaria parasites in asymptomatic school children in Mutengene and evaluate the performance characteristics of the ‘CareStartTM Malaria HRP2 pf (CAT NO: G0141, ACCESSBIO)’ rapid diagnostic test (RDT) using light microscopy as a gold standard.
Study Design: The study was a cross-sectional survey.
Place and Duration of Study: The study was carried out in Mutengene, from February to March, 2013.
Methodology: A total of 406 pupils were studied. Demographic data was taken for each child and capillary blood was collected. Blood films were prepared for the assessment of parasite density and speciation. A drop of blood was used on the RDT to determine the malaria status.
Results: The mean age at 95% confidence interval (CI) was 8 ± 2 years (range = 4 -15 years) and the overall prevalence of malaria was 39.9% (162) by microscopy. The geometric mean parasite density (GMPD) was 2332.7 parasites/µL (range: 218 - 16000). Only 386 pupils were examined by both methods. More pupils were positive by microscopy (40.9%, CI = 36.1 - 45.9) than by RDT (27.9%, CI = 23.7 - 32.7) and the difference was statistically significant (χ2 = 16.1, P <0.0001). The majority of those detected had high infection (≥ 5000 parasite/µL). Less than 50% of those with low (25.0%, CI = 12.0 - 44.9), moderate (40.7%, CI = 32.24-49.70) and high parasitaemia (75%, CI = 5.00-89.82) were positive by RDT and the difference was significant (χ2 = 10.09, P = 0.006). The RDT showed a low sensitivity of 48.5% (CI = 40.3 – 56.9%) and specificity of 84.0% (CI = 80.0- 88.2%).
Conclusion: More research needs to be done on the RDT to improve on its performance characteristics before it could be used in mass surveillance programmes.