Results of an international transferability study of the BINACLE (binding and cleavage) assay for in vitro detection of tetanus toxicity.

Behrensdorf-Nicol, Heike A; Bonifas, Ursula; Isbrucker, Richard; Ottiger, Hanspeter; Tierney, Robert; Hanschmann, Kay-Martin; Weisser, Karin; Krämer, Beate (2014). Results of an international transferability study of the BINACLE (binding and cleavage) assay for in vitro detection of tetanus toxicity. Biologicals, 42(4), pp. 199-204. Elsevier 10.1016/j.biologicals.2014.05.001

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Tetanus vaccines contain detoxified tetanus neurotoxin. In order to check for residual toxicity, the detoxified material (toxoid) has to be tested in guinea pigs. These tests are time-consuming and raise animal welfare issues. In line with the "3R" principles of replacing, reducing and refining animal tests, the "binding and cleavage" (BINACLE) assay for detection of active tetanus neurotoxin has been developed as a potential alternative to toxicity testing in animals. This in vitro test system can discriminate well between toxic and detoxified toxin molecules based on their receptor-binding and proteolytic characteristics. Here we describe an international study to assess the transferability of the BINACLE assay. We show that all participating laboratories were able to successfully perform the assay. Generally, assay variability was within an acceptable range. A toxin concentration-dependent increase of assay signals was observed in all tests. Furthermore, participants were able to detect low tetanus neurotoxin concentrations close to the estimated in vivo detection limit. In conclusion, the data from this study indicate that the methodology of the BINACLE assay seems to be robust, reproducible and easily transferable between laboratories. These findings substantiate our notion that the method can be suitable for the routine testing of tetanus toxoids.

Item Type:

Journal Article (Original Article)

Division/Institute:

05 Veterinary Medicine > Research Foci > Host-Pathogen Interaction
05 Veterinary Medicine > Department of Infectious Diseases and Pathobiology (DIP) > Institute of Virology and Immunology
05 Veterinary Medicine > Department of Infectious Diseases and Pathobiology (DIP)

ISSN:

1045-1056

Publisher:

Elsevier

Language:

English

Submitter:

Susanne Portner

Date Deposited:

04 Sep 2018 12:41

Last Modified:

17 Oct 2018 08:49

Publisher DOI:

10.1016/j.biologicals.2014.05.001

PubMed ID:

24882365

Uncontrolled Keywords:

In vitro toxicity assay Tetanus neurotoxin Toxoid vaccines Transferability study

BORIS DOI:

10.7892/boris.70399

URI:

https://boris.unibe.ch/id/eprint/70399

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