Abstract
Antibodies play a central role in prophylaxis against many infectious agents. While neutralization is a primary function of antibodies, the Fc- and complement-dependent activities of these multifunctional proteins may also be critical in their ability to provide protection against most viruses. Protection against viral pathogens in vivo is complex, and while virus neutralization—the ability of antibody to inactivate virus infectivity, often measured in vitro—is important, it is often only a partial contributor in protection. The rapid fluorescent focus inhibition test (RFFIT) remains the “gold standard” assay to measure rabies virus–neutralizing antibodies. In addition to neutralization, the rabies-specific antigen-binding activity of antibodies may be measured through enzyme-linked immunosorbent assays (ELISAs), as well as other available methods. For any disease, in selecting the appropriate assay(s) to use to assess antibody titers, assay validation and how they are interpreted are important considerations—but for a fatal disease like rabies, they are of paramount importance. The innate limitations of a one-dimensional laboratory test for rabies antibody measurement, as well as the validation of the method of choice, must be carefully considered in the selection of an assay method and for the interpretation of results that might be construed as a surrogate of protection.
Highlights
Whether an animal control worker wants to determine if a rabies vaccine booster is necessary to establish an acceptable preexposure status, or a physician is considering the causes of encephalitis in a child, or the owner of an immunologically compromised dog is worried that the dog’s response to rabies vaccination will not be sufficient to pass a serological test allowing them to travel to a rabies-free area, or a researcher is trying to determine if the rabies vaccine-bait response is adequate in a raccoon population, or one needs to assign a potency value to a rabies immune globulin product, all demand an accurate assessment based on the measurement of circulating antibodies
rabies virus neutralizing antibodies (RVNA) alone can result in viral clearance from the central nervous system (CNS) of Citation: Moore SM, Hanlon CA (2010) Rabies-Specific Antibodies: Measuring Surrogates of Protection against a Fatal Disease
Detection of specific rabies virus antibodies in the cerebrospinal fluid (CSF) is diagnostic of rabies infection, whether the test performed is one of the binding assays or a neutralization assay
Summary
Whether an animal control worker wants to determine if a rabies vaccine booster is necessary to establish an acceptable preexposure status, or a physician is considering the causes of encephalitis in a child, or the owner of an immunologically compromised dog is worried that the dog’s response to rabies vaccination will not be sufficient to pass a serological test allowing them to travel to a rabies-free area, or a researcher is trying to determine if the rabies vaccine-bait response is adequate in a raccoon population, or one needs to assign a potency value to a rabies immune globulin product, all demand an accurate assessment based on the measurement of circulating antibodies In each of these situations the measurement or the detection of rabies-specific virus-neutralizing or other antibodies will help resolve the question. We discuss the following (1) the role of rabies-specific antibodies in disease prevention, (2) the methods that can be used for detection and measurement, and (3) the considerations and current requirements for method standardization and validation
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