Quality Assurance (QA) Assessment for Malaria Rapid Diagnostic Test in Ngoma District, Eastern Province of Rwanda: A cross-sectional prospective study

Abstract

Background Currently, malaria rapid diagnostic tests (mRDTs) are increasingly used for diagnosis of malaria, particularly in community where microscopy-based diagnosis is not practical. However, the diagnostic accuracy of mRDTs performed by the community health workers (CHWs) remains unknown. This study was conducted to determine the accuracy of mRDT results performed by CHWs in Ngoma district, eastern province of Rwanda. Method This was a cross sectional prospective study. 420 blood samples of patients self-reported to CHWs for malaria diagnosis were collected and analyzed by CHWs using mRDT and quality control tests were performed by using microscopy as a reference test. The study was conducted from 22nd April to 08th July, 2021. Results Among the 420 patients, 234 (55.71%) were females and 186 (44.29%) were males. Malaria test positivity was 2.62% by using mRDT and 1.67% by using microscopic test. The sensitivity and specificity of mRDT were 85.71% and 98.78% respectively. Negative predictive value, positive predictive value and accuracy of mRDTs were 99.75%, 54.54% and 98.57% respectively. Sensitivity of mRDT was below the WHO recommended sensitivity (>95%) although the specificity (98.78%) was within the WHO recommended specificity (>=90). There was a substantial agreement between mRDT and malaria microscopic test results, k=0.642. Conclusion mRDTs continue to be an appropriate choice for malaria diagnosis in the absence of microscopy.