Abstract
BackgroundIn Ethiopia, light microscopy is the gold standard for malaria diagnosis although it is not available in most peripheral health facilities. It is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. This study was aimed at testing the diagnostic performance of CareStart™ malaria rapid diagnostic test (RDT) with reference to light microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia.MethodsBlood samples were collected from 254 patients suspected to have malaria at Kola Diba Health Center in the late malaria transmission peak season from November 2011 to December 2011. The samples were examined immediately by light microscopy and the RDT (CareStart™ Malaria HRP2/pLDH COMBO Test kit). Statistical analysis was performed using SPSS version 16 and the JavaStat two-way contingency table analysis.ResultsThe overall sensitivity and specificity of CareStartTM RDT was found to be 95% (90–97.9%, 95% CI) and 94.2% (90.9–96%, 95% CI), respectively. The sensitivity of the CareStartTM RDT for Plasmodium falciparum or mixed infection was calculated to be 92.9% (82.5–98%, 95%CI) while a sensitivity of 90.9% (74.1–98.4%, 95%CI) was found for non-falciparum species. The specificity for P. falciparum or mixed infections was found to be 95.4% (92.5–96.8%, 95%CI) while it was 97.3% (94.8–98.4%, 95%CI) for non-falciparum species. There was an excellent agreement between the two tests with a kappa value of 0.918.ConclusionThe CareStartTM RDT test showed good sensitivity and specificity with an excellent agreement to the reference light microscopy. The RDT could therefore be used in place of light microscopy, which in poor set-ups cannot be used routinely.
Highlights
In Ethiopia, light microscopy is the gold standard for malaria diagnosis it is not available in most peripheral health facilities
Using logistic regression analysis the sex (OR=0.551, 95%Confidence Interval (CI)=0.325–0.932) and resident of the participants (OR=0.483, 95%CI=0.254– 0.919) were found to be significantly associated with parasite positivity
The present study revealed a high sensitivity and specificity of the CareStartTM rapid diagnostic test (RDT) (Table 4)
Summary
In Ethiopia, light microscopy is the gold standard for malaria diagnosis it is not available in most peripheral health facilities. It is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. The malaria transmission pattern in Ethiopia is highly seasonal and unstable [4] Because of this unstable transmission and infrequent exposure to infection, immunity is generally under-developed and all age groups are at risk of malarial disease. In Ethiopia, clinical diagnosis and empirical treatment has been the mainstay of malaria management in areas where laboratory facilities are not available. Light microscopy (LM) remains preferred and standard for laboratory diagnosis of malaria it is not accessible and affordable in most peripheral health facilities in the country. For a better and sustainable control, malaria diagnosis requires a more rapid, easy, sensitive and specific method
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