Efficacy demonstration of tetanus vaccines by double antigen ELISA.
Abstract: This paper describes a double antigen ELISA (DAE) for rapid, specific and reliable assessment of the antitetanus immune status of horses and sheep. Compared with the indirect ELISA, the double antigen ELISA has the advantage of species-independent testing of sera. Thanks to its test design, it is more specific since the detected antibodies are forced to bind tetanus toxoid twice. In addition, it is very sensitive to tetanus antibodies, enabling the detection of low antibody titres, in range which is relevant for the assessment of the protective status (tetanus toxin neutralising antibodies). The detection limit of the DAE for tetanus antibodies is in the order of 10(-4) EU/ml. A comparison of in vitro results of individual sera with in vivo titres showed that horse sera with titres of 0.04 and 0.05 EU/ml in the DAE showed titres of > 0.05 IU and 0.034 IU/ml respectively during in vivo testing thus indicating good agreement. For tested sheep sera which were rated > 0.05 IU/ml in vivo, the corresponding titre in the DAE was 0.24 EU/ml. Clear tetanus antitoxin establishment of protective ELISA limits requires further comparative examination of sera with low titres (< 1.0 EU/ml) in the double antigen ELISA and the toxin neutralisation test. With the double antigen ELISA, efficacy can be determined for marketing authorisation procedures of tetanus vaccines ad us. vet. As a consequence, the toxin neutralisation test (still being the standard method of choice for quantifying tetanus toxin neutralising antitoxin titres) could be replaced, since it requires too great a number of animals per test and involves considerable suffering for the animals. The test described here reduces the use of mice and guinea pigs within vaccine efficacy testing. In addition, it involves less exposure of the laboratory personnel to toxin.
Publication Date: 2005-12-13 PubMed ID: 16336937
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- Journal Article
Summary
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The study explored the use of a double antigen ELISA (DAE) for the accurate assessment of immunity to tetanus in horses and sheep, potentially offering a method to reduce animal testing in vaccine development.
A New Technique for Immunity Assessment
- The paper discusses a method known as double antigen ELISA (DAE) that allows for a quick, precise, and reliable examination of the immunity of horses and sheep against tetanus.
- The methodology offers a unique advantage over indirect ELISA because it isn’t species-specific; it can be used to test serum from any species.
- The design of the double antigen ELISA is such that it’s more specific; the antibodies that are detected have to bind to the tetanus toxoid twice, which increases the chances of accurate detection.
- The method is also highly sensitive to tetanus antibodies, capable of detecting low antibody titres which is significant for checking the protective status.
Comparison with In Vivo Testing
- The study also compared in vitro results of individual sera with in vivo titres. Horse sera that demonstrated titres of 0.04 and 0.05 EU/ml in the DAE also showed comparable results in in vivo testing.
- For sheep sera rated > 0.05 IU/ml in vivo, the corresponding titre in the DAE was 0.24 EU/ml, demonstrating decent compatibility.
- However, the paper suggests that to fully establish protective ELISA limits for tetanus antitoxin, further comparative testing of sera with low titres is required using the double antigen ELISA and the toxin neutralisation test.
Animal Welfare and Safety for Personnel
- The double antigen ELISA could potentially replace the currently used toxin neutralisation test, which requires a substantial number of animals per test, causing considerable animal suffering.
- Using the DAE for assessing the efficacy of tetanus vaccines could diminish the use of animals like mice and guinea pigs in vaccine testing.
- Moreover, less exposure of lab personnel to toxins is an added advantage of this method, promoting safer working conditions.
Cite This Article
APA
Rosskopf U, Noeske K, Werner E.
(2005).
Efficacy demonstration of tetanus vaccines by double antigen ELISA.
Pharmeuropa Bio, 2005(1), 31-52.
Publication
Researcher Affiliations
- Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany. rosut@pei.de
MeSH Terms
- Animals
- Bacterial Vaccines / standards
- Enzyme-Linked Immunosorbent Assay / methods
- Horses
- Quality Control
- Reproducibility of Results
- Sheep
- Tetanus / immunology
- Tetanus Toxoid / standards
Citations
This article has been cited 1 times.- Hammarlund E, Thomas A, Poore EA, Amanna IJ, Rynko AE, Mori M, Chen Z, Slifka MK. Durability of Vaccine-Induced Immunity Against Tetanus and Diphtheria Toxins: A Cross-sectional Analysis.. Clin Infect Dis 2016 May 1;62(9):1111-1118.
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