- First CLIA automatized test for Tetanus IgG
- High sensitivity and specificity
- Cartridge optimized for laboratory routine testing
The Tetanus IgG test is an immunological chemiluminescent (CLIA) test for the quantity determination of the specific IgG class antibodies against the Tetanus Toxoid Antigen in serum and plasma (K3-EDTA and heparin sodium) samples, using IDS automated analyzers.
This dosage is used as a diagnostic aid in the assessment of the immune status of the patient with reference to infection by the tetanus bacteria.
Tetanus is a disease caused by Clostridium (C.) tetani, an obligate anaerobic spore-forming bacillus. It may live in the intestines of many animals and, occasionally, humans without causing disease or inducing immunity.
In the presence of anaerobic conditions, spores will develop into the vegetative form which produces Tetanospasmin, a highly potent neurotoxin, which produces intense muscle spasms. The toxin is neurotropic, binding specifically to ganglioside-containing receptors at nerve termini. Once inside neurons, Tetanus toxin cannot be neutralized by Tetanus anti-toxin (1).
After an incubation period of a few days up to several weeks, initial nonspecific symptoms appear like fatigue, headache, dizziness, muscle pain. This phase is followed by characteristic cramps which diffuse from craniofacial to caudal muscles affecting also the respiratory muscles(2).
In the meantime, renal, cardiac and circulatory failure and disseminated intravasal coagulation (DIC) may occur in the patient. Unfortunately, at least one third of the patients die(2).
To check for immune status and the individual response to vaccination, the detection of antitoxin IgG antibodies in the form of in vivo and in vitro techniques are used(1).
Despite the general acceptance of the in vivo neutralization assay as the “gold standard”, variation in the methodology does occur. For this reason, the in vitro tests are preferable since they are sensitive, accurate, simple and rapid.
1. Borrow, Ray, Paul, Balmer, Martha H. Roper – The immunological basis for immunization series – Module 3: Tetanus update 2006 WHO publication.
2. Robert-Kock-Institute Epidemiologisches Bulletin, 27/2002.
3. V. Rapisarda, M. Bracci, G. Nunnari, M. Ferrante and C. Ledda, Tetanus immunity in construction workers in Italy, Occupational Medicine 2014;64:217–219.
4. H.J. Larson, Maternal immunization: The new “normal” (or it should be), Elsevier Journal, Vaccine 33 (2015) 6374–6375.
5. J.P. Schröder, W.D. Kuhlmann, Chr. Trendelenburg, Knowledge-based approach to clinical decision-support system, with an application in Tetanus serology, Clin Chim Acta, Volume 222, Issues 1–2, 1993, Pages 79-83.
6. J.P. Schröder, W.D. Kuhlmann, Tetanusimmunität bei Männern und Frauen in der Bundesrepublik Deutschland. Immun. Infekt. 19, 14-17, 1991.