Assessing the Performance of CareStart™ Malaria Rapid Diagnostic Tests in Northwest Ethiopia: A Cross-Sectional Study

BACKGROUND: While rapid diagnostic tests are an alternative diagnostic tests for microscopy in the diagnosis of malaria in rural settings, their performance has been inconsistent. Performance of rapid diagnostic tests might be affected by manufacturing process, transportation and storage, parasitemia level, and skill of personnel who perform the tests. Therefore, periodic evaluation of the local field performance of rapid diagnostic tests is mandatory in order to make early corrections in case of decreased performance. METHODS: A facility-based cross-sectional study was conducted from January to May 2020 among 257 malaria-suspected patients attending selected health centers in Bahir Dar Zuria district. Capillary blood was collected from each participant and tested for Plasmodium infection by CareStart™ rapid diagnostic test kit and thin and thick blood film microscopy. Data were analyzed using statistical software for social sciences version 20 and MedCalc software version 19.3. Sensitivity, specificity, positive and negative predictive values, and kappa value were calculated to evaluate the performance of rapid diagnostic tests against microscopy. RESULTS: Among 257 study participants, 47 (18.3%) were tested positive for Plasmodium infection by at least one of the diagnostic methods. Rapid diagnostic tests revealed 3 false positive and 3 false negative results. The sensitivity and specificity of CareStart Malaria Pf/Pv Combo test were 93.2% and 98.6%, respectively (kappa = 0.918). CONCLUSION: CareStart™ rapid diagnostic test has comparable performance with microscopy for malaria diagnosis. We recommend continued use of CareStart Malaria Pf/Pv Combo test at health posts in Ethiopia where microscopy is not available.