Abstract
As a neglected zoonotic disease, rabies causes approximately 5.9 × 104 human deaths annually, primarily affecting low- and middle-income countries in Asia and Africa. In those regions, insufficient surveillance is hampering adequate medical intervention and is driving the vicious cycle of neglect. Where resources to provide laboratory disease confirmation are limited, there is a need for user-friendly and low-cost reliable diagnostic tools that do not rely on specialized laboratory facilities. Lateral flow devices (LFD) offer an alternative to conventional diagnostic methods and may strengthen control efforts in low-resource settings. Five different commercially available LFDs were compared in a multi-centered study with respect to their diagnostic sensitivity and their agreement with standard rabies diagnostic techniques. Our evaluation was conducted by several international reference laboratories using a broad panel of samples. The overall sensitivities ranged from 0% up to 62%, depending on the LFD manufacturer, with substantial variation between the different laboratories. Samples with high antigen content and high relative viral load tended to test positive more often in the Anigen/Bionote test, the latter being the one with the best performance. Still, the overall unsatisfactory findings corroborate a previous study and indicate a persistent lack of appropriate test validation and quality control. At present, the tested kits are not suitable for in-field use for rabies diagnosis, especially not for suspect animals where human contact has been identified, as an incorrect negative diagnosis may result in human casualties. This study points out the discrepancy between the enormous need for such a diagnostic tool on the one hand, and on the other hand, a number of already existing tests that are not yet ready for use.
Highlights
Rabies is one of the most important yet neglected zoonotic diseases, causing approximately 5.9 × 104 human deaths annually and primarily affecting low- and middle-income countries in Asia and Africa [1,2]
The deadly encephalitis is caused by different lyssaviruses, with the prototypical rabies virus (RABV) being their best-known representative and responsible for the vast majority of human cases [3]
The United Against Rabies (UAR) consortium, comprising of the international organizations World Health Organization (WHO), World Organisation for Animal Health (OIE), Food and Agriculture Organization of the United Nations (FAO) and the Global Alliance for Rabies Control (GARC), have established a global strategic plan to reduce the burden of rabies, with the goal of reaching zero human deaths due to dog-mediated rabies by 2030 [6]
Summary
Rabies is one of the most important yet neglected zoonotic diseases, causing approximately 5.9 × 104 human deaths annually and primarily affecting low- and middle-income countries in Asia and Africa [1,2]. One of the pillars of this plan is to increase and harmonize rabies surveillance, ideally based on laboratory confirmation of clinically suspect animals to provide evidence-based guidance [7], i.e., both for bite case management and guidance for individual treatment as well as for general data aggregation to inform policymakers To this end, post mortem techniques recommended for the detection of the disease in animals [8] include the direct fluorescent antibody test (DFA), which was previously considered the gold standard and is still used as the reference method in most laboratories. Lateral flow devices (LFDs), known as rapid immunodiagnostic tests (RIDTs), immunodiagnostic assays or immunochromatographic strip tests, offer a promising alternative to conventional diagnostic methods and have the potential to strengthen prevention and control efforts in low-resource settings [17] These LFDs are principally based on colloidal gold conjugated monoclonal antibodies that capture the antigen within a sample. We determined the target of the diagnostic antibody used in the LFDs by assessing the reaction towards standardized samples consisting of transfected cells expressing only glycoprotein G, nucleoprotein N, matrix protein M, and phosphoprotein P, respectively
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