Multicenter comparative study of a new ELISA, PLATELIA™ RABIES II, for the detection and titration of anti-rabies glycoprotein antibodies and comparison with the rapid fluorescent focus inhibition test (RFFIT) on human samples from vaccinated and non-vaccinated people

• Published in: Vaccine Vol. 25; no. 12; pp. 2244 - 2251
• Main Authors: Feyssaguet, M, Dacheux, L, Audry, L, Compoint, A, Morize, J.L, Blanchard, I, Bourhy, H
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 08.03.2007; Elsevier; Elsevier Limited
• Subjects: Allergy and Immunology; Antibodies, Viral - blood; Antibodies, Viral - immunology; Antibody detection; Applied microbiology; Biological and medical sciences; Comparative studies; ELISA; Enzyme-Linked Immunosorbent Assay - methods; Enzymes; Fluorescent Antibody Technique - methods; Fundamental and applied biological sciences. Psychology; Glycoproteins - analysis; Glycoproteins - immunology; Humans; Immunization; Microbiology; Miscellaneous; Mortality; Rabies; Rabies - diagnosis; Rabies - immunology; Rabies - virology; Rabies Vaccines - analysis; Rabies Vaccines - immunology; Rabies virus; Reproducibility of Results; Rhabdoviridae - immunology; Sensitivity and Specificity; Synthetic products; Vaccination - methods; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Virology; Antibody detection; Rabies virus; ELISA; Human; Nervous system diseases; Antibody; Multicenter study; Glycoprotein; Vaccine; Infection; Virus; Mononegavirales; Rhabdoviridae; Viral disease; Rabies; Lyssavirus; Detection; ELISA assay; Comparative study; Quantitative analysis
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2006.12.012

Abstract The envelope glycoprotein G of rabies virus induces the production of neutralising antibodies, which are important in protection against rabies. Therefore, titration of anti-envelope glycoprotein antibodies is a good indicator of the degree of immunity in people during anti-rabies treatment or after vaccination. According to the World Health Organization (WHO) guidelines, a booster vaccine dose should be given if the rabies antibody titre falls below 0.5 IU/ml. Titration of anti-rabies antibodies is also useful for plasma centers in the preparation and standardization of human anti-rabies gamma-globulins for therapeutic use and to a lesser extent for the diagnosis of rabies in human sera and cerebrospinal fluid (CSF). This paper presents a new enzyme-linked immunosorbent assay (ELISA), PLATELIA™ RABIES II, developed for rabies envelope glycoprotein antibody detection or titration and its comparison to the current reference method (RFFIT). The data collected during validation of the test in a multicenter study are analysed to give a sound overall knowledge of the capabilities of the PLATELIA™ RABIES II, for instance specificity, linearity, accuracy, precision, detection limit and quantitation limit. To this aim, human serum samples from a total of 1348 vaccinated or non-vaccinated people were tested in parallel using the new ELISA and the RFFIT for the presence of anti-rabies antibodies. Data generated indicate a linear relationship across the range of titration between the two methods. The sensitivity reaches 98.6% and the specificity 99.4%. This study indicates that this new ELISA test is as sensitive and specific as the current standardized reference method. The method is simple, safe, rapid and can be considered as a useful alternative to the neutralisation test.