COMPARISON OF CARE START™ HRP2/pLDH COMBO RAPID MALARIA TEST WITH LIGHT MICROSCOPY AMONG GOVERNMENTAL HEALTH INSTITUTUONS IN METEKEL ZONE, BENISHANGUL- GUMUZ REGION, ETHIOPIA, 2018.

Abstract

Abstract Background: In 2010, WHO recommended that, where possible all cases should be confirmed by parasitological diagnosis before treatment with anti-malarial medicines. Severe malaria disease needed to be confirmed by parasitological examination of the presence of falciparum malaria by either thick blood smear or RDTs although their sensitivity depends on parasitic density. The use of antigen-detecting rapid diagnostic tests (RDTs) provides the possibility of parasite-based diagnosis in areas where good quality microscopy cannot be maintained. Objective: The purpose of the Research is to compare the performance of CareStart™ rapid malaria test in reference to the gold standard Light Microscopy among governmental health Institutions in Metekel Zone of Benishangul-Gumuz region. Methods and Materials: A Cross-Sectional Study was conducted in Benishangul-Gumuz region to compare the performance of malaria diagnostic tests among acute febrile patients suspected for malaria who were visiting the Out patients (OPDs) of three Health institutions. A total of 2677patients were included in the study. Data was collected using standardized questionnaire and laboratory request and entered, cleaned and analyzed using Epi-Info 7 and SPSS version 23 statistical software packages. The Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Percent agreement and kappa Value was calculated. Result: The overall sensitivity of CareStart Malaria RDT was 97.1% (95–98%, 95% CI) and its sensitivity was 99.5% (99.5–99.8%, 95% CI). Moreover, the overall Positive Predictive value (PPV) of the test kit was 96.8% (94-98%, 95% CI) and its Negative Predictive Value (NPV) was 99.5% (99.3–99.8%, 95% CI). The calculated sensitivity of the CareStart RDT for Plasmodium falciparum or mixed infection was 97.6% (95.5-99.7%, 95%CI) and the specificity of the kit for the same species was 99.5% (95.2-99.8%, 95%CI). In addition, a sensitivity of 95.2% (81.5–98.9%, 95%CI) and a specificity of 99.5% (99.2-99.8%, 95%CI) for Plasmodium vivax was found. There was an excellent agreement between the two test methods with a kappa value of 0.965 (0.927-1.0, 95%CI). Conclusion: The CareStart RDT test showed high sensitivity and specificity with an excellent agreement to the reference light microscopy. Hence, the use of the RDT should be strengthened in place where use of light microscopy is limited. Key Words: Blood Film, Malaria, Metekel, Malaria rapid diagnostic test, Microscopy.