Clinical Utility of Monobiomaker-Based Malaria Rapid Diagnostic Test Kits at a Military Medical Centre in Ghana: An Exploration Pilot Study

Abstract

Background: Proliferation of non-falciparum species of plasmodium into predominant falciparum populations compromises the utility of monobiomaker based malaria Rapid Diagnostic Test (mRDT). This study evaluated the validity of a mono-biomarker based Carestart®) and Paracheck™ mRDTs in use at a Military Medical Centre in Ghana. Methodology: The study was designed to assess the validity of named mRDTs in a setting in Ghana. Blood samples collected from a consecutive series of 207 febrile patients in the months of June and July 2020, were tested for malaria parasites, using the mRDTs and microscopy as the gold standard. Prevalence, validity, and reliability metrics were determined using Frequentist, Receiver Operating Characteristics (ROC), and Kappa statistics, respectively. Results: The prevalence was 23.2% and 12.3% using microscopy and candidate mRDT, respectively. Sensitivities and specificities were 53.2% and 98.1% (Carestart®), 45.8% and 99.4% (Paracheck), respectively. Neither ROC analysis showed a significant disparity between mRDTs (Carestart®: AUROC=0.75 vs Paracheck™: AUROC=0.73), nor the reliability index showed disagreement between both mRDTs (Cronbach’s α = 0.92). But there was significant disagreement between microscopy and mRDTs (Carestart®: Kappa=0.58 vs Paracheck™: Kappa=0.55). Conclusion: The use of a monobiomaker mRDTs in this study led to a significant variation between the ‘internal’ and ‘ecological’ validity metrics. Averagely, 84% mRDT false negatives was non-falciparum. It is therefore, critical to accelerate the implementation of WHO’s recommendation to switch from mono to multiple biomarker (s)-based mRDTs for detecting both falciparum and non-falciparum species. Extended research is needed to consolidate our understanding of the dynamics of malaria among our military personnel exposed to non-falciparum plasmodium.

HRP2 and PLDH Performance Comparison as Rapid Diagnostic Tools for Symptomatic Malaria Patients at Rugazi HC IV in Rubirizi District

“…Consistent frequencies of positive cases discovered by both types of mRDTs result from the diagnostic sensitivity and specificity for both HRP2 and pLDH markers being similar across investigations. These studies all used the same testing procedures and protocols, and the mRDTs' similar test quality, production standards, and storage conditions also contributed to the consistency that was seen [26,27].…”