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Development of Tests in a Standardized Kit Format for Diagnosis of Arboviral Infections in Resource-Limited, Primary Health Care Setting


Background: Arthropod-borne virus infections may present with clinical symptoms similar to those of other bacterial or viral infections, such as a flu-like illness, encephalitis, or polio-like myelitis. Laboratory diagnosis is essential to determine etiology and calculate disease burden in order to guide treatment and control strategies, particularly if there is an effective vaccine available, such as for yellow fever and Japanese encephalitis. Detection of virus-specific immunoglobulin M (IgM) antibody in an enzyme-linked immunosorbant assay (MAC-ELISA) is the standard serological test for diagnosis of acute arbovirus infections. However, diagnostic tests are not available for many of these “neglected” but medically important arboviral diseases in resource poor laboratories. Samples must be sent to reference laboratories for testing, which delays diagnosis and reduces the number of laboratory-confirmed cases. “In-house” assays developed in reference laboratories are unsuitable for use in laboratories with limited technical capacity, due to the lack of standardized reagents and format. Project Goal: The goal of this project is the development of a laboratory test based on IgM detection to diagnose arboviral infections in a standardized kit format. A prototype yellow fever virus MAC- ELISA should be developed initially showing proof-of-concept. The developed assays should have the characteristics of simplicity and robustness as described by the World Health Organization. The format should be designed so that the assay can easily be modified to test for other arboviruses by switching out a limited number of standardized and validated reagents and controls. The variation, reproducibility, and accuracy of the test should be characterized and benchmarked against current tests. Suitability of the test for use in resource-limited surveillance laboratories should be demonstrated. Impact: The test is meant to be a screening test used at primary health care level. A rapid diagnostic test is essential to support vaccination and surveillance programs by increasing the number of biologically confirmed cases, thus improving the accuracy of disease burden estimates. These data will in turn improve the effectiveness of vaccine programs for vaccine-preventable diseases such as yellow fever. The primary benefit of such diagnostics is intended for resource-poor countries. Such rapid arbovirus diagnostics can be incorporated into resource-poor countries as laboratory capacity-building efforts. Innovative approaches such as “dipstick” technology that can be used in the clinic and the field are already being employed by manufacturers of commercial diagnostic assays for other medically important infectious diseases. Rapid diagnostics is an area that should be of particular interest to small business concerns. Laboratories in developing countries have either no alternative methods or only elaborate and inefficient methods to diagnose arbovirus infections at this time, a gap which a small business has the opportunity to fill.
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