The Centers for Disease Control and Prevention (CDC) recently unveiled a new rabies rapid test that can more easily and precisely diagnose rabies infections in animals. According to the recently published CDC study by Gigante and colleagues, the LN34 pan-lyssavirus real-time polymerase chain reaction (PCR) assay (LN34) displays a higher diagnostic capability when compared to the direct fluorescent antibody (DFA) test, the current gold standard. The reliability and robustness of the LN34 test rivals the DFA test in several aspects, and could very well replace the DFA test as the primary rabies diagnostic method.

In the aforementioned CDC study, 2,978 animal brain samples from the Americas, Europe, Africa, and Asia were assessed. The samples were obtained from over 60 rabies vector species, including dogs, racoons, skunks, foxes, and bats. LN34 correctly identified all DFA-positive samples, and yielded definitive results for 80 samples deemed inconclusive or untestable by the DFA test; 29 of these were rabies-positive. Additionally, LN34 generated no false negatives, fewer false positives, and fewer inconclusive results compared to the DFA test. But beyond numbers, how are these results meaningful?

The regions most affected by rabies include several resource-poor countries within Africa and Asia that do not have the capacity to easily rule out the disease. Due to limited access to testing equipment, the rabies vaccine, and skilled laboratory workers outside of urban areas, there is a high cost associated with travelling to and receiving the vaccine. However, the new LN34 test does not require extensive training or special lab equipment to interpret the results; it can be utilized worldwide in a variety of settings.

More importantly, LN34 will likely reduce unnecessary treatment and lessen the economic and social burden to patients. Currently, the DFA test is the only internationally approved method for diagnosing rabies; however, major public health organizations are in talks to add PCR-based tests, such as LN34, for primary diagnosis. GlobalData epidemiologists believe that the incorporation of LN34 testing may result in a shift in rabies epidemiology, since accurate case identification and early treatment impacts both incidence and mortality.

For more insight and data, visit the GlobalData Report Store – Verdict Medical Devices is part of GlobalData Plc.

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