Assessment of a Highly Sensitive Rapid Diagnostic Test for Reactive Case Detection of Malaria Infections in Myanmar
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Background Recent epidemiological data indicate that 30–50% of all malaria infections are asymptomatic, with parasite densities below the limit of detection of standard diagnostic tests. A highly sensitive rapid diagnostic test (hsRDT) was developed to detect these low-density Plasmodium falciparum ( P. falciparum ) infections. This study evaluated the diagnostic performance of both hsRDTs and conventional RDTs (cRDT) in reactive case detection (RACD) activities among individuals (contacts) living and/or working in proximity to an “index case” in Ann Township in Rakhine State, Myanmar. Methods This prospective community-based RACD study was conducted in 2017–2018 among residents aged at least five years and older in 50 villages of Ann Township. We assessed the sensitivity, specificity, and positive and negative predictive values of both a hsRDT (NxTek™ Eliminate Malaria Ag P.f) and a cRDT (SD Malaria Ag P.f/P.v) using an ultra-sensitive polymerase chain reaction (usPCR) diagnostic assay as the gold standard. Results A total of 1,990 participants, all contacts of 51 index P. falciparum cases, were recruited. Among them, 28 (1.4%) tested positive by cRDT, 78 (3.9%) by hsRDT, and 171 (8.6%) by usPCR for P. falciparum mono-infection. The sensitivity and specificity of the hsRDT were 27.9% (95% CI: 18.2–39.6%) and 98.8% (95% CI: 98.2–99.4%), respectively, while the sensitivity and specificity of the cRDT were 13.7% (95% CI: 7.6–20.7%) and 100% (95% CI: 100–100%), respectively. The differences in sensitivity and specificity between hsRDT and cRDT were statistically significant (p < 0.01 for both). Conclusions Although hsRDTs identified more infected contacts than cRDTs during reactive case detection, they have low overall sensitivity compared to usPCR. In resource-limited settings like Myanmar, using hsRDTs in RACD should consider the field feasibility and cost-effectiveness of hsRDTs to accelerate malaria elimination efforts.
